medical oncology - bc cancer includes a wide variety of phase i, ii, iii and iv clinical trials....

Biennial Research Report 2005 ‐2006

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MEDICAL ONCOLOGY B C C A N C E R A G E N C Y 600 West 10th Avenue Vancouver, BC V5Z 4E6 Telephone: 604‐877‐6000 ext. 2738

Ou r R e s e a r c h F o c u s : The department’s research objective is to address the rising incidence of cancer, related to the aging population and through studies of the effectiveness of the increasingly complex treatment programs incorporating new targeted small molecules and immunotherapeutic agents. Clinical research includes a wide variety of Phase I, II, III and IV clinical trials. These include the development of new anti‐cancer drugs, the evaluation of new doses schedules and combinations of drugs in the phase II setting and participation in multi‐institutional phase III studies and post‐marketing phase IV trials evaluating effective new cancer treatments. These clinical studies are supported directly by three important platforms: 1. Our Clinical Trials Units undertake carefully designed investigation of new treatments or combinations of old and new treatments in human patients. Drugs studied include chemotherapy drugs, hormone treatments, immune treatments, or new drugs designed to attack or block the function or growth of cancer cells in new ways. The Clinical Trials teams are highly skilled and experienced staff that provide expertise in protocol development, regulatory & ethics support, contract & budget management (closely linked with the Technology Development Office to mange intellectual property, etc.), data management, and overall trial management for the conduct of many different phases of clinical trials research. Since 2004, all current clinical trials have been put on the BC Cancer Agency’s website, where additional information about clinical trials can be accessed at www.bccancer.bc.ca under ‘Clinical Trials Research’. 2. The Investigational Drug Program (IDP) is growing rapidly at the BC Cancer Agency due to the commitment and expertise of the translational research clinical and scientific teams and the increasing availability of new agents for testing in North America. IDP can expedite the development of promising new therapeutic agents to the initial stage of early clinical trials. As a comprehensive unit, IDP offers a full range of services in four basic areas: i) pre‐clinical drug assessment, ii) rodent based GLP toxicology, iii) formal investigational drug development and cGMP manufacturing and iv) clinical trials. These four components integrate seamlessly to move novel anti‐cancer therapies into first‐in‐man studies. IDP has expertise with a variety of drug classes, including conventional small molecule drugs and immunotherapy through to the latest gene therapy approaches. Scientists and oncologists working at the BC Cancer Agency have capabilities unmatched in Canada to develop and evaluate new strategies for the treatment

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http://www.bccancer.bc.ca/

British Columbia Cancer Agency

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of cancer. At present, IDP is the only facility in British Columbia able to develop anti‐cancer therapeutics from bench through to early stage clinical evaluations, a continuity of service from formulation to trial that is of immeasurable benefit to the research and biotechnology sectors of the Province as well as to academia (see Advanced Therapeutics for further detail). 3. Pharmacy Drug Mart & Pharmaco‐Oncology Forecasting and Feedback. The Pharmacy Drug Mart comprises a single longitudinal resource of all cancer drugs dispensed across the province and prescription data going back to 1995. The prescription data includes the patient identifier (BC Cancer Agency number), prescription number, dispensing date, drug, dose, quantity dispensed, prescribing physician, and for drugs dispensed from BC Cancer Agency centre, the protocol code. The BC Cancer Agency is the sole payer for cancer drugs in the province of BC. Thus information captured in the Pharmacy Data Mart covers all chemotherapy and most hormonal agents dispensed to cancer patients in BC going back to 1995. This makes this data mart unique in Canada. The data mart gives the Systemic Program the ability to carry out population based analyses on drugs utilization to specific groups of cancer patients and/or drugs and drug therapies. The Pharmaco‐Oncology Forecasting and Feedback program uses pharmacoeconomic principles and data from the drug datamart to produce evidence‐based, population‐based, financial planning for the treatment of cancer in the province. Outcomes research (cost‐effectiveness analyses), is also performed to justify and maintain appropriate funded programs. The expertise and extensive data available also permit quality assurance and other research projects. Work performed via our pharmacoeconomics and drug datamart capabilities are presented and published regularly in local, national, and international conferences and journals.

K e y R e s e a r c h S t a f f Researcher Name Position & Cross‐Appointments Susan O’Reilly MD VP Cancer Care;

Head, Medical Oncology; Provincial Leader, Systemic Therapy Program, BCCA Clinical Professor, Medicine, UBC Head, Medical Oncology, UBC

Kim Chi MD Medical Oncologist, BCCA/VCC Assistant Professor, Medicine, UBC Stephen Chia MD Medical Oncologist, BCCA/VCC Assistant Professor, Medical Oncology, UBC Joseph Connors MD Chair, Lymphoma Tumour Group Clinical Professor, Medical Oncology, UBC Tom Ehlen MD Medical Oncology, Gyne Oncology, BCCA/VCC Assistant Professor, Obstetrics & Gynaecology, UBC Karen Gelmon MD Medical Oncologist, BCCA/VCC;

Chair, Breast Cancer Tumour Group; Head, Investigational Drug Program

Clinical Professor, Medical Oncology, UBC Sharlene Gill MD Medical Oncologist, BCCA/VCC

Chair, Gastrointestinal Tumour Group Assistant Professor, Medical Oncology, UBC Martin Gleave MD Chair, Genitourinary Tumour Group, BCCA

Professor, Urologic Sciences, UBC Director, Clinical Research, Prostate Centre, VGH

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Pippa Hawley MD Medical Oncologist, BCCA/VCC Clinical Instructor, General Internal Medicine, UBC Cheryl Ho MD Medical Oncologist BCCA/VCC Clinical Assistant Professor, Medical Oncology, UBC Paul Hoskins MD Medical Oncologist, BCCA/VCC Clinical Professor, Medical Oncology, UBC Hagen Kennecke MD Medical Oncologist, BCCA/VCC Clinical Assistant Professor Richard Klasa MD Medical Oncologist, BCCA/VCC Clinical Assistant Professor, Medical Oncology, UBC Margaret (Meg) Knowling MD Medical Oncologist;

Chair, Sarcoma Tumour Group, BCCA/VCC Clinical Assistant Professor, Medical Oncology, UBC Christian Kollmansberger MD Medical Oncologist, BCCA/VCC Clinical Associate Professor, Medicine, UBC Stephen Lam MD Chair, Lung Tumor Group, BCCA Professor of Medicine, UBC Janessa Laskin MD Medical Oncologist, BCCA/VCC Clinical Assistant Professor, Medical Oncologist, UBC Christopher Lee MD Medical Oncologist, BCCA/VCC Clinical Instructor, Medical Oncology, UBC Caroline Lohrisch MD Medical Oncologist, BCCA/VCC Clinical Assistant Professor Grant MacLean MD Medical Oncologist, BCCA/VCC Clinical Professor, Medical Oncology, UBC Nicol MacPherson MD Medical Oncologist, BCCA/VCC Clinical Assistant Professor, Medical Oncology, UBC Barbara Melosky MD Medical Oncologist, BCCA/VCC Clinical Assistant Professor, Medical Oncology, UBC Nevin Murray MD Medical Oncologist, BCCA/VCC Clinical Professor, Medical Oncology, UBC Kerry Savage MD Medical Oncologist, BCCA/VCC Assistant Professor, Medical Oncology, UBC Laurie Sehn MD Medical Oncologist, BCCA/VCC Clinical Instructor, Medical Oncology, UBC Brian Thiessen MD Medical Oncologist, BCCA/VCC Clinical Assistant Professor, Neurology, UBC

T r a i n i n g A . ) S umm a r y o f T r a i n e e s Total No. of

Current Students Core Residents Rotating

Residents Fellows Undergraduates

2005 63 10 33 2 18 2006 102 10 61 2 29

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B . ) T r a i n e e Aw a r d s Name Award Received

Arnold Gold Foundation Humanism and Excellence in Teaching Award (2006) (pan‐American special honor)

University of Alberta Hospital Medical Staff Society Medical Publication Prize (2006)Arnold Gold Foundation Humanism and Excellence in Teaching Award (2006)The A.M. Edwards Award for Medical Education (2006)The Gordon Denchfield Thompson Scholarship (2005)University of Alberta Division of Clinical Hematology Award (2005)

David Hui

Internal Medicine Residency Travel Funding Award (2005)

S e l e c t e d P e r s o n a l Aw a r d s a n d H o n o u r s Name Distinguished Award/Honour S Gill UBC Departmental Scholar Award (2005)

S e l e c t e d C u r r e n t C o n t r i b u t i o n s Name Membership/ Committee Involvement

Member of the Investigational New Drugs Executive Committee, NCIC – Clinical Trials Group, 2006

K Chi

Member of the Genitourinary Cancer Disease Site Executive Committee, NCIC – Clinical Trials Group, 2006 Member, Clinical Advisory Committee, World Health Organization Classification of Neoplastic Diseases of the Hematopoetic and Lymphoid Systems

J Connors

Member, SAB, Lymphoma Research Foundation (US) Member, Board of Directors, Lymphoma Foundation Canada (LFC) L Sehn

Research Fellowship Director, Lymphoma Foundation Canada (LFC) Co‐Chair, Gynecologic Cancer Steering Committee (GCSC) Ovarian Cancer Task Force, US National Institutes of Health / National Cancer Institute, Bethesda, MD, USA

KD Swenerton

International Ovarian Cancer Intergroup (Clinical Trials) Network, NCIC‐CTG Representative Member

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C l i n i c a l T r i a l s For a current list of clinical trials, please refer to www.bccancer.bc.ca/RES/ClinTrials/. BREAST CANCER CLINICAL TRIALS 1. A double blind re‐randomization to Letrozole or placebo for women completing five years of

adjuvant Letrozole in the MA.17 study Allan S (VIC) 1Pansegrau G (FVC) Shenkier T (VCC) Souliere S (CSI)

NCIC2

Opened 10‐Dec‐20043, Status: Open4

MA17R5

2. A pharmacokinetic interaction study of Docetaxel (RP56976, TAXOTERE ®) 75 mg/m2 IV on the combination therapy Doxorubicin (50 mg/m2 IV) and Cyclophosphamide (500 mg/ m2) in the treatment of advanced breast cancer Gelmon K (VCC) Industry

Opened 23‐Jun‐2003, Status: Closed P1TACDOC

3. A phase II multi‐centre study to assess the positive predictive value of Positron Emission Tomography (PET) in the preoperative evaluation of internal mammary lymph nodes in breast cancer patients Bernstein V (VIC) BCCA

Opened 30‐Apr‐2003, Status: Open BRPET2

4. A phase II multi‐centre trial of Caelyx in combination with Herceptin in HER‐2 over‐expressing advanced breast cancer Swenerton K (VCC) Industry

Opened 01‐Jun‐2001, Status: Follow‐up BRTLDOXT

5. A phase II, randomized, open‐label study of single agent CI‐1033 in patients with metastatic breast cancer Gelmon K (VCC) Industry

Opened 11‐Jun‐2003, Status: Follow‐up BRT1033

6. A phase II, single arm, multicenter study to evaluate the efficacy and safety of the combination of Omnitarg™ (pertuzumab) and Herceptin® (trastuzumab) in patients with HER2‐positive metastatic breast cancer Gelmon K (VCC) Industry

Opened 28‐Jun‐06, Status: Open BRTPMTM

7. A phase II study of a second generation clusterin antisense oligonucleotide (OGX‐011) in combination with docetaxel in advanced breast cancer

Chia S (VCC) Norris B (FVC) Ellard S (CSI)

NCIC Opened 13‐Sep‐2005, Status: Follow‐up IND164

1 Principal Investigator from each centre: VCC = Vancouver Cancer Centre; FVC = Fraser Valley Centre; VIC = Vancouver Island Center; CSI = Centre for the Southern Interior 2 NCIC = Funding Source (See pages 16‐17 for list of acronyms) 3 Open = Earliest date of clinical trials opening (may vary across regional centres) 4 Status = as of December 31st, 2006 5 MA17R = BCCA Protocol Code

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8. A phase II study of Lapatinib for brain metastases in subjects with ErbB2‐positive breast cancer following Trastuzumab‐based systemic therapy and cranial radiotherapy Shenkier T (VCC) Industry

Opened 7‐Jul‐06, Status: Follow‐up BRTLAPA

9. A phase II trial of Neoadjuvant chemotherapy with 5‐Fluorouracil, Epirubicin and Cyclophosphamide (FEC100) followed by Docetaxel, Capecitabine (XT) for Her‐2 non‐overexpressing locally advanced breast cancer Chia S (VCC) Bouttell E (CSI) Pansengrau G (FVC) Macpherson N (VIC)

BCCA Opened 23‐Nov‐2004, Status: Open BRTDCECF

10. A phase III adjuvant trial of sequenced EC+ Filgrastim + Epoetin Alfa followed by Paclitaxel versus Sequenced AC followed by Paclitaxel versus CEF as therapy for premenopausal women and early postmenopausal women who have had potentially curative surgery for node positive or high risk node negative breast cancer Gelmon K (VCC) Czerkawski B (CSI) Martin LA (FVC)

NCIC, Industry Opened 09‐May‐2001, Status: Open MA21

11. A phase III randomized study of Exemestane plus placebo versus Exemestane plus Celecoxib versus placebo in postmenopausal women at increased risk of developing breast cancer Gelmon K (VCC) Ellard S (CSI)

NCIC Opened Oct‐04, Status: Open BRMAP3

12. A phase III trial evaluating the role of ovarian function suppression and the role of Exemestane adjuvant therapies for premenopausal women with endocrine responsive breast cancer Kennecke H (VCC) Pansegrau G (FVC) Bouttell E (CSI)

NCIC Opened 06‐Jul‐2005, Status: Open MAC4

13. A phase III trial of novel Epothilone BMS‐247550 plus Capecitabine versus Capecitabine alone in patients with advanced breast cancer previously treated with or resistant to an Anthracycline and aho are Taxane resistant Shenkier T (VCC) Industry

Opened 21‐Jul‐2005, Status: Follow‐up BRT24755

14. A randomized active‐controlled study of AMG 162 in breast cancer subjects with bone metastasis who have not previously been treated with bisphosphonate therapy Kennecke H (VCC) Industry

Opened 15‐Feb‐2005, Status: Open BRTANLON

15. A randomized, double‐blind, multicenter study of Denosumab compared with Zoledronic Acid (Zometa?) in the treatment of bone metastases in subjects with advanced breast cancer Kennecke H (VCC) Industry

Opened 1‐Dec‐06, Status: Open BRTDENZO

16. A randomized, double blind, multicentre study to compare the efficacy and tolerability of Fulvestrant (FASLODEX ™) vs. Exemestane (AROMASIN ™) in postmenopausal women with hormone receptor positive advance breast cancer with disease progression Chia S (VCC) Industry

Opened 18‐May‐2004, Status: Active Tx BRTEFECT

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17. A randomized double blind phase II study of Anastrozole plus Lonafarnib (SCH 66336) or Anastrozole plus placebo for the treatment of subjects with advanced breast cancer Chia S (VCC) Industry

Opened 15‐Feb‐2005, Status: Open BRTANLON

18. A randomized, double‐blind, placebo‐controlled, multi‐centre study to evaluate the efficacy and safety of Bevacizumab (Avastin™) in combination with Docetaxel (Taxotere®) compared with Docetaxel plus placebo, as first line treatment for patients with HER‐2 negative breast cancer Lohrisch C (VCC) Industry

Opened 23‐Jun‐06, Status: Open BRTBEDOC

19. A randomized multi‐center study comparing prolonged primary systemic endocrine therapy with Femara® (letrozole) alone or in combination with Zometa® (zoledronic acid) in early breast cancer (NEOCAN study) Gelmon K (VCC) Bernstein V (VIC)

Industry Opened 15‐Nov‐2005, Status: Open BRTZAL

20. A randomized phase II study of two different schedules of Rad001c in patients with recurrent/metastatic breast cancer Ellard S (CSI) Gelmon K (VCC) Norris B (FVC)

NCIC Opened 07‐Jun‐2005, Status: Open BRIND163

21. A randomized phase III trial of Exemestane vs Anastrozole with or without Celecoxib in postmenopausal women with receptor positive primary breast cancer Macpherson N (VIC) Martin LA (FVC) Taylor M (CSI)

NCIC Opened Feb‐04, Status: Open BRMA27

22. A randomized phase III trial of Paclitaxel versus Paclitaxel plus Bevacizumab (rhuMAb VEGF) as first‐line therapy for locally recurrent or metastatic breast cancer Norris B (FVC) CTSU

Opened 27‐Nov‐2003, Status: Closed E2100

23. A randomized phase III trial of Paclitaxel versus Paclitaxel plus Bevacizumab (rhuMAb VEGF) as first‐line therapy for locally recurrent or metastatic breast cancer Shenkier T (VCC) NCIC

Opened 31‐Mar‐2003, Status: Follow‐up BRMAC3

24. A randomized, placebo‐controlled, double blind trial evaluating the effect of Exemestrane in clinical stage T 1‐3 N 0‐1 M 0 postmenopausal breast cancer patients completing at least five years of Tamoxifen therapy Shenkier T (VCC) NSABP

Opened 31‐Mar‐2003, Status: Active Tx BRB33

25. A randomised three‐arm multi‐centre comparison of 1 year and 2 years of Herceptin® versus no Herceptin® in women with Her2‐Positive primary breast cancer who have completed adjuvant chemotherapy Lohrisch C (VCC) Norris B (FVC) Ellard S (CSI)

NCIC Opened 30‐Aug‐2002, Status: Active Tx MA24

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26. Antisense oligonucleotide (ogx‐011) in combination with Docetaxel in advanced breast cancer Anderson H (CSI) Industry

Opened Oct 2005 BR17704

27. Comparison of aerobic versus resistance exercise training in enhancing quality of life in early stage breast cancer survivors receiving chemotherapy: A multicenter randomized trial Gelmon K (VCC) NCIC

Opened 22‐Aug‐2003, Status: Closed BRSTART

28. HERA: A randomized three‐arm multicentre comparison of 1 year and 2 years of Herceptin® vs No Herceptin® in women with HER‐2 positive primary breast cancer who have completed adjuvant chemotherapy re‐randomization Lohrisch C (VCC) Ellard S (CSI) Norris B (FVC) Bernstein V (VIC)

NCIC Opened Feb‐03, Status: Closed to screen 4/2004 BRMA24R

29. Protocol A: proposal for neoadjuvant chemotherapy with 5‐Fluorouracil, Epirubicin and Cyclophosphamide (FEC100) followed by locoregional radiation followed by Docetaxel, Cisplatin and Herceptin(TCH) forER‐2 Overexpressing locally advanced breast cancer Chia S (VCC) BCCA

Opened 23‐Nov‐2004, Status: Open BRTFECDT

30. The association of breast density changes, plasma hormone changes, and breast cancer recurrence Kennecke H (VCC) NCIC

Opened 16‐Nov‐06, Status: Open BRMA27D

31. The influence of five years of adjuvant Anastrozole or Exemestane on bone mineral density in postmenopausal women with primary breast cancer Kennecke H (VCC) NCIC

Opened 16‐Nov‐06, Status: Open BRMA27B

32. The influence of Letrozole on bone mineral density in women with primary breast cancer completing five or more years of adjuvant tamoxifen. A companion study to NCIC CTG MA.17 Shenkier T (VCC) NCIC

Opened 11‐Oct‐2001, Status: Follow‐up BRMA17B

CENTRAL NERVOUS SYSTEM 33. A phase I/II study of GW572016 in patients with recurrent malignant glioma

Thiessen B (VCC) Khoo K (CSI)

NCIC Opened 09‐May‐2005, Status: Open CNIND170

34. A phase III, randomized, open‐label study of IV Edotecarin vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in patients with glioblastoma multiforme that has progressed/recurred after Alkylator‐based (neo)adjuvant chemotherapy Thiessen B (VCC) Industry

Opened 21‐Jul‐2004, Status: Close CNTEDTCL

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35. A trial of Dalteparin low molecular eight Heparin for primary prophylaxis of venous thromboembolism in brain tumor patients Thiessen B (VCC) Other Govʹt Trial

Opened 27‐Mar‐2003, Status: Close CNTDALT

GASTROINTESTINAL‐ BILIARY 36. A phase III multicenter, single blind, randomized study of XL119 versus 5 Fluorouracil (5 FU) plus

Leucovorin (LV) in subjects with advanced biliary tumors not amenable to conventional surgery Kollmannsberger C (VCC) Industry

Opened 21‐Jul‐2005, Status: Follow‐up GITXL119

GASTROINTESTINAL‐ COLORECTAL 37. A 2X2 randomized phase III study of intermittent oral Capecitabine in combination with

intravenous Oxaliplatin (Q3W) (“XELOX”) with/without intravenous Bevacizumab (Q3W) Vs Bolus and continuous infusion Fluorouracil/Intravenous Leucovorin with intravenous Oxaliplatin (Q2W) (FOLFOX‐4) with or without intravenous Bevacizumab as first‐line treatment for patients with metastatic colorectal cancer arms B&D Melosky B (VCC) Gurjal A (FVC) Taylor M (CSI) Fitzgerald C (VIC)

Industry Opened 27‐Oct‐2003, Status: Follow‐up NO16966

38. A phase I/II study of Capecitabine (Xeloda) in patients with advanced colorectal cancer not known to derive survival benefits from combination therapy with 5FU and Irinatecan Taylor M (CSI) Martin LA (FVC)

LRCC/ Industry Opened Jan‐03, Status: Closed Capecitabine

39. A phase II study of chemoradiation for locally advanced and low rectal cancers A‐CORRECT (Avastin‐Capecitabine‐Oxaliplatin‐Radiation Rectal Cancer Trial) Kennecke H (VCC) BCCA

Opened 1‐Oct‐06, Status: Open GITBCORR

40. A phase II trial of VEGF trap in patients with previously treated metastatic colorectal cancer Kollmannsberger C (VCC) Other Coop Group ‐ PMHC

Opened 15‐Feb‐07, Status: Open GI7498

41. A phase III randomized study of Cetuximab (Erbitux, C225) and best supportive care versus best supportive care in patients with pretreated metastatic epidermal growth factor receptor (EGFR) ‐ positive colorectal carcinoma Anderson H (VIC) Le L (FVC) Kennecke H (VCC) Taylor M (CSI)

NCIC‐ CTG & Industry Opened July‐2004, Status: Follow‐up GICO17

42. A randomized, multicenter, phase III study to compare the efficacy of Panitumumab in combination with Oxaliplatin/ 5‐fluorouracil/ leucovorin to the efficacy of Oxaliplatin/ 5‐fluorouracil/ leucovorin alone in patients with previously untreated metastatic colorectal cancer Melosky B (VCC) Industry

Opened 20‐Dec‐06, Status: Open GITPAFOX

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43. A randomized phase III trial of Oxaliplatin (OXAL) plus 5‐Fluorouracil (5‐FU)/Leucovorin (CF) with or without Cetuximab (C225) after curative resection for patients with stage III colon cancer Gill S (VCC) Jasas K (FVC)

NCIC Opened 01‐Feb‐2007, Status: Open CRC2

44. A randomized, three‐arm, multinational phase III study to investigate bevacizumab (q3w or q2w) in combination with either intermittent capecitabine plus oxaliplatin (ʺXELOXʺ) (q3w) or fluorouracil / leucovorin with oxaliplatin (ʺFOLFOX‐4ʺ) versus “FOLFOX‐4” regimen alone as adjuvant chemotherapy in colon carcinoma Rao S (CSI) Gurjal A (FVC) Anderson H (VIC) Melosky B (VCC)

Industry Opened 05‐May‐2005, Status: Open GITAVANT

45. An open label randomized phase III study of intermittent oral Capecitabine in combination with IV Oxaliplatin (Q3W) (ʺXeloxʺ) vs. Bolus and continuous infusion 5FU/LV with IV Oxaliplatin (Q2W) (ʺFolfox‐4ʺ) as first line treatment for patients with metastatic colorectal cancer Taylor M (CSI) Gurjal A (FVC) Fitzgerald C (VIC) Melosky B (VCC)

Industry Opened Feb‐04, Status: Follow‐up GITOXELA

46. An open‐label randomized phase III study of intermittent oral Capecitabine in combination with intravenous Oxaliplatin (Q3W) (ʺXELOXʺ) versus Fluorouracil/ Leucovorin as adjuvant therapy for patients who have undergone surgery for colon carcinoma, AJCC/UIC Gurjal A (FVC) Industry

Opened 27‐Oct‐2003, Status: Closed NO16968

47. First line Bevacizumab and chemotherapy in metastatic cancer of the colon or rectum. An expanded access program Melosky B (VCC) Le L (FVC) Rao S (CSI) Fitzgerald C (VIC)

Industry Opened Jun‐2005, Status: Open GITBEAT

48. The circadian rhythm in sleep and activity, as measured by actigraphy in patients with stage III colon cancer undergoing adjuvant chemotherapy: Prognostic significance for recurrence and survival. A companion study in patients participating in study N016968 adjuvant XELOX vs. 5FU/LV in stage III colon cancer Taylor M (CSI)

Industry Opened Oct‐03

GASTROINTESTINAL‐ GASTROINTESTINAL STROMAL TUMOURS (GIST) 49. A phase III randomized double‐blind study of adjuvant STI571 (Gleevec) vs placebo in patients

following the resection of primary gastrointestinal stromal tumor (GIST) Knowling M (VCC) Attwell A (VIC)

ACOSOG – NCIC Opened Dec‐03; Status: Closed SAZ9001

50. A phase III randomized, intergroup trial assessing the clinical activity of STI‐571 at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) Expressing the kit teceptor tyrosine kinase Knowling M (VCC) NCIC

Opened 20‐Jun‐2001, Status: Follow‐up SASR4

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51. A treatment protocol for patients with gastrointestinal stromal tumor who are ineligible for participation in other SU011248 Protocols and are refractory to or intolerant of imatinib mesylate Knowling M (VCC) Industry

Opened June 2004, Status: Closed SAT1036

GASTROINTESTINAL‐ HEPATOCELLULAR CARCINOMA 52. A phase II study of G3139 with Doxorubicin in advanced hepatocellular carcinoma

Gill S (VCC) Other Co‐op Group – PMHC Opened 07‐Sep‐2004, Status: Closed GITG3139

53. A phase II study of SB‐715992 (D‐21266;NSC727990) in subjects with locally advanced, recurrent or metastatic hepatocellular carcinoma Gill S (VCC) NCIC

Opened 07‐Jun‐2005, Status: Open GIIND168

GASTROINTESTINAL‐ PANCREATIC 54. A phase I/II study of AZD0530 in combination with Gemcitabine in patients with advanced

pancreatic cancer Gill S (VCC) NCIC

Opened 5‐May‐06, Status: Open GIIND173

55. A phase III adjuvant trial in pancreatic cancer comparing 5‐Fu and D‐L folinic acid Vs Gemcitabine Vs no adjuvant treatment Weinerman B (VIC) Rao S (CSI) Taylor M (VCC)

NCIC & Industry Opened Jul‐04, Status: Open GIPA2

56. A phase III randomized open‐label study comparing Gemcitabine plus Cetuximab (IMC‐C225) versus Gemcitabine as first‐line therapy of patients with advanced pancreatic cancer (PAC1)

Rao S (CSI) Le L (FVC)

NCI/ NCIC/ CTSU Opened May‐05; Status: Open GIPAC1

57. A phase III trial of Irofulven versus 5‐Fluorouracil in Patients with Gemcitabine‐refractory advanced pancreatic adenocarcinoma Melosky B (VCC) Industry

Opened 22‐Mar‐2002, Status: Closed GITIROF

58. A randomized, double‐blind, placebo‐controlled, multi‐centre phase III trial to evaluate the efficacy and safety of adding Bevacizumab to Gemcitabine and Erlotinib in patients with metastatic pancreatic cancer Gill S (VCC) Industry

Opened 04‐Oct‐2005, Status: Follow‐up GIT17706

59. A randomized, open label, multicentre phase III study comparing the efficacy and safety of Gemcitabine and CPT‐11 to Gemcitabine alone in patients with locally advanced or metastatic pancreatic cancer Shah A (VCC) Industry

Opened 31‐Oct‐2001, Status: Closed GIPAIR

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60. A randomized placebo controlled study of OSI‐774 (Tarceva) plus Gemcitabine in patients with locally advanced, unresectable or metastatic pancreatic cancer Taylor M (VCC) NCIC

Opened 18‐Nov‐2002, Status: Closed GIPA3

61. An open label, stratified, single‐arm phase II study of RAD001 in patients with advanced pancreatic neuroendocrine tumor (NET) after failure of cytotoxic chemotherapy Amil S (VCC) Industry

Opened 6‐Dec‐06, Status: Open GITRAD

GENITOURINARY – BLADDER 62. A randomized phase III trial comparing immediate versus deferred chemotherapy after radical

cystectomy in patients with PT3‐PT4, and/or n + m0 transitional cell carcinoma (TCC) of the bladder Ellard S (CSI) NCIC

Opened July‐2002, Status: Open GUBL8

GENITOURINARY – UROTHELIAL 63. A prospective, randomised phase III trial of I.V. Vinflunine plus best supportive care as second

line therapy versus best supportive care after a platinum‐containing regimen, in patients with advanced transitional cell carcinoma of urothelial tract protocol Kollmannsberger C (VCC) Martins H (VIC)

Industry Opened 12‐Jul‐2005, Status: Follow‐up GUTVINF

64. A randomized phase III study comparing paclitaxel/ cisplatin/ gemcitabine and cisplatin/gemcitabine in patients with metastatic or locally advanced urothelial cancer without prior systemic therapy Chi K (VCC) NCIC

Opened 14‐Nov‐2002, Status: Closed GUBL7

GENITOURINARY – PROSTATE 65. A multicenter phase III randomized trial comparing docetaxel administered either weekly or every

three weeks in combination with prednisone versus mitoxantrone in combination with prednisone for metastatic hormone refractory prostate cancer Chi K (VCC) Industry

Opened 11‐May‐2001, Status: Follow‐up GUTTX327

66. A multicentre single‐arm, open‐label study of combination neoadjuvant hormone therapy and weekly Taxotere® prior to radical prostatectomy in localized prostate cancer Chi K (VCC) Other Co‐op Group

Opened 01‐May‐2001, Status: Closed GUTPNDOC

67. A phase I/II, pharmacokinetic, and biologic correlative study of G3139 (antisense oligonucleotide directed to BCL‐2) and Docetaxel in patients with hormone refractory prostate cancer (Phase 1) Chi K (VCC) Industry

Opened 14‐Nov‐2001, Status: Closed P1TG3139

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68. A phase I/II, pharmacokinetic, and biologic correlative study of G3139 (antisense oligonucleotide directed to BCL‐2) and docetaxel in patients with hormone‐refractory prostate cancer (Phase 2) Chi K (VCC) Industry

Opened 31‐Mar‐2003, Status: Closed GUTG3139

69. A phase II multicenter, randomized, double blind, study of docetaxel plus DN101 or placebo in androgen independent prostate cancer Chi K (VCC) Other Co‐op Group

Opened 31‐Oct‐2003, Status: Closed GUTDOCDN

70. A phase II study of BAY 43‐9006 (NSC 724772) in patients with hormone refractory prostate cancer Chi K (VCC) Ellard S (CSI)

NCIC Opened June‐2004, Status: Follow‐up GUIND167

71. A phase II study of neoadjuvant hormone therapy and weekly OGX‐011 (clusterin antisense oligonucleotide) prior to radical prostatectomy in patients with localized prostate cancer Chi K (VCC) Grant – UBC

Opened 14‐Jun‐2005, Status: Open GUTPOGX

72. A phase II study of GTI‐2040 in combination with docetaxel and prednisone in hormone‐refractory prostate cancer Chi K (VCC) Other Co‐op Group

Opened 09‐Dec‐2004, Status: Follow‐up GUGTIDP

73. A phase II study of neoadjuvant docetaxel + neoadjuvant/adjuvant hormone therapy and locoregrional radiation therapy for high risk localized adenocarcinoma of the prostate McKenzie M and Chi K (VCC) Ellard S (CSI)

Industry Opened Oct‐02 P2 Taxotere

74. A phase II study of neoadjuvant docetaxel plus neoadjuvant/adjuvant hormone therapy and locoregional radiation therapy for high risk localized adenocarcinoma of the prostate McKenzie M (VCC) Bernstein V (VIC)

BCCA/ Industry Opened Apr‐05, Status: Closed GUTBDOC

75. A phase III, randomized, open‐label study evaluating DN‐101 in combination with Docetaxel in androgen‐independent prostate cancer (AIPC) (ASCENTE‐2) Chi K (VCC) Saucic D (CSI)

Industry Opened 3‐Nov‐06, Status: Open GUTDN101

76. A pilot study evaluating the safety and feasibility of OGX‐011 in combination with second‐line chemotherapy in patients with hormone refractory prostate cancer Chi K (VCC) Industry

Opened 28‐Nov‐06, Status: Open GUTOGX07

77. A randomized phase II study of OGX‐011 in combination with Docetaxel and Prednisone or Docetaxel and Prednisone alone in patients with metastatic hormone refractory prostate cancer Chi K (VCC) Ellard S (CSI)

NCIC‐ Industry Opened 12‐Sep‐2005, Status: Open GUIND165

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78. A randomized phase II trial of Strontium‐89 with or without Cisplatin for the palliation of bone pain secondary to hormone refractory prostate cancer Chi K (VCC) Kwan W (FVC)

BCCA Opened 28‐Jul‐2003, Status: Open GUTPPS2

79. A three‐arm randomized phase II clinical study of Luven/ Prednisolone, Irofluven/ Capecitabine/ Prednisolone or Mitozantrone/Prednisolone in Docetaxel‐pretreated hormone refractory prostate cancer patients Chi K (VCC) Industry

Opened 16‐Dec‐2004, Status: Follow‐up GUTIROF

80. Choices after consultation: Active surveillance vs immediate treatment for localized prostate cancer – survey format Halperin R (CSI)

BCCA Opened May‐06 None

81. Non‐randomized, open‐label, multiple‐dose study to assess the effect of PTK787/ZK222584 on midazolam pharmacokinetics in non‐metastatic (M0) prostate cancer patients with serological relapse Chi K (VCC)

Industry Opened 22‐Feb‐2005, Status: Close GUTPTKMD

GENITOURINARY – RENAL CELL 82. A phase II study evaluating the efficacy and safety of ABT‐751 in patients with renal cell carcinoma

Chi K (VCC) Industry Opened 06‐Oct‐2003, Status: Closed GUTAB751

83. A phase II study of AZD2171 in progressive unresectable, recurrent or metastatic renal cell carcinoma (RCC) Kollmannsberger C (VCC) NCIC

Opened 16‐May‐06, Status: Open GUTPHAZD

84. A phase II study of Triapine (NSC 663249) in previously untreated patients with recurrent renal cell carcinoma Kollmannsberger C (VCC) NCIC

Opened 31‐May‐2004, Status: Follow‐up GUIND161

85. A phase III, randomized study of SU011248 versus interferon alpha (IFN‐?) as first–line systemic therapy for subjects with metastatic renal cell carcinoma Ellard S (CSI) Kollmannsberger C (VCC) Martins H (VIC)

Industry Opened 25‐Nov‐2004, Status: Follow‐up GUTSUIFN

86. A phase III, three arm, randomized open‐label study of interferon alpha alone, CCI‐779 alone, and combined interferon alpha and CCI‐779 in first‐line poor‐prognosis subjects with advanced renal cell carcinoma Chi K (VCC) Ellard S (CSI)

Industry Opened Aug‐04 None

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87. A SU011248 treatment protocol for patients with cytokine‐refractory metastatic, renal cell carcinoma who are ineligible for participation in other SU011248 protocols and may derive benefit from treatment with SU011248 Kollmannsberger C (VCC) Martins H (VIC) Ellard S (CSI)

Industry Opened 19‐Oct‐2005, Status: Active Tx GUT11248

GENITOURINARY – GERM CELL 88. Prospective open‐labeled non randomised phase‐II study of SU011248 (Sunitinib) in male patients

with relapsed or cisplatin‐refractory germ cell cancer ‐ A CUOG / GTCSG cooperative phase II study Kollmannsberger C (VCC) BCCA

Opened 28‐Nov‐06, Status: Open GUTSUN

HEAD AND NECK 89. A comparison of acute oral mucositis between morning and afternoon radiotherapy in patients

receiving radiation treatment for cancer of the head and neck Leung C (FVC) Wong F (FVC)

NCIC Opened 29‐May‐2000, Status: Closed HN3

90. A phase I/II trial of weekly Docetaxel and Cisplatin for locoregionally recurrent and/or metastatic squamous cell carcinoma of the head and neck Chia S (VCC) Industry

Opened 14‐Jul‐2003, Status: Follow‐up P1THNDC

91. A phase II study of SB‐715992 in recurrent or metastatic squamous cell carcinoma of the head and neck Chia S (VCC) NCI‐US

Opened 04‐Jan‐2006, Status: Follow‐up HN6803

92. A phase III randomized trial of concomitant radiation, Cisplatin, and Tirapazamine (SR259075) versus concomitant radiation and Cisplatin in patients with advanced head and neck cancer Leung C (FVC) Industry

Opened 27‐Oct‐2003, Status: Closed EFC4690

HEMATOLOGIC: LYMPHOMA AND LEUKEMIA 93. A multi‐center phase III study to investigate the safety and efficacy of Ttreandatm (bendamustine

hcl) in patients with indolent non‐hodgkin’s lymphoma (NHL) who are refractory to Rituximab Hoskins P (VCC) Industry

Opened 23‐May‐06, Status: Open LYTBENDA

94. A multicentre, randomized, double‐blind, placebo‐controlled, comparative trial of amd3100 (240mg/kg) plus G CSF (10mg/kg) versus G CSF (10mg/kd) plus placebo to mobilize and collect > 5 x 106 cd34+ cells/kg in non‐hodgkin’s lymphoma patients for autologous transplantation Smith C (BMT/VGH) Industry

Opened 03‐March‐2006, Status: Closed AMD3101CA

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95. A multicentre, randomized, double‐blind, placebo‐controlled, comparative trial of amd3100 (240mg/kg) plus G CSF (10mg/kg) versus G CSF (10mg/kd) plus placebo to mobilize and collect > 6 x 106 cd34+ cells/kg in multiple mycelia patients for autologous transplantation Smith C (BMT/VGH) Industry

Opened 03 March 2006, Status: Closed AMD3102CA

96. A multicenter, single‐arm, open‐label expanded access program for lenalidomide plus dexamethasone in previously treated subjects with multiple myeloma Song K (BMT/VGH) Industry

Opened 09‐Dec‐2005, Status: Open CC5013‐MM‐016

97. A pharmacodynamic phase II study of oral valganciclovir as preemptive therapy in allogeneic blood and marrow transplant recipients Lavoie J (BMT/VGH) Roche (Grant funded)

Sponsor: Leuk/BMT Program of BC & Hopital Maisonneuve Rosemont) Opened 15‐Sept‐2005, Status: Closed SC‐04‐01

98. A phase I‐II study of autologous transplantation with th9402 photodynamic cell processing of the progenitor cell graft for patients with non‐hodgkin’s lymphoma Toze C(BMT/VGH) Industry

Opened 19‐Jan‐2005, Status: Closed TH9402/II/NHL/002

99. A phase I/II study of SKI‐606 in Philadelphia chromosome positive leukemias Sutherland J (CSI)

Industry Opened Oct‐2006 SKI606

100. A phase Ia/II multicenter, dose‐escalation study of oral amn107 on a continuous daily dosing schedule in adult patients with gleevec (imatinib)‐resistant cml in accelerated phase or blast crisis, relapsed/refractory ph+ all, and other hematologic malignancies Forrest D (BMT/VGH) Industry

Opened 05‐May‐2006, Status: Open CAMN107A2101

101. A phase II clinical trial of oral suberoylanilide hydroxamic acid (l‐001079038) in patients with relapsed diffuse large b‐cell lymphoma (DLBCL) Al‐Tourah A (VCC) Industry

Opened 28‐Jul‐2005, Status: Open LYTSHA

102. A phase II, randomized, double‐blind, placebo‐controlled study comparing the combination of CNTO 328 (anti‐il‐6 monoclonal antibody) and decade versus decade alone in subjects with relapsed or refractory multiple myeloma Sutherland H (BMT/VGH)

Industry Opened Nov/06, Status: Open CNTO 328

103. A phase II study to assess the safety and efficacy of DBD combination therapy (doxil/caelyx) [doxorubicin hcl liposome injection], velcade [bortezomib] and dexamethasone) for previously untreated multiple myeloma patients Sutherland H (BMT/VGH) Industry

Opened 12‐July‐2006, Status: Closed Doxil‐MMY‐2001

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104. A phase II trial tailoring first‐line therapy for advanced stage diffuse large b‐cell non‐hodgkinʹs lymphoma based on mid‐treatment positron emission tomography (PET) scan results Sehn L (VCC) Gill J (FVC) Sutherland J (CSI) Macpherson N (VIC)

BCCA Opened 11‐Aug‐06, Status: Open LYTPET

105. A phase II study of bms‐354825 in subjects with accelerated phase chronic myeloid leukemia resistant to or intolerant of imatinib mesylate Forrest D (BMT/VGH) Industry

Opened 06‐May‐2005, Status: Closed CA180005

106. A phase II study of bms‐354825 in subjects with myeloid blast phase chronic myeloid leukemia resistant to or intolerant of imatinib mesylate Forrest D (BMT/VGH) Industry


107. A phase II study of bms‐354825 in subjects with lymphoid blast phase chronic myeloid leukemia or philadelphia chromosome positive acute lymphoblastic leukemia resistant to or intolerant of imatinib mesylate Forrest D (BMT/VGH) Industry


108. A phase II study of PS‐341 (NSC 681239) in patients with untreated or relapsed mantle cell lymphoma Sehn L (VCC) NCIC

Opened 17‐Jan‐2003, Status: Active Tx LYIND150

109. A phase II study to determine the activity of bms‐354825 in subjects with chronic phase philadelphia chromosome‐positive chronic myeloid leukemia who have disease that is resistant to high dose imatinib mesylate (gleevec®) or who are intolerant of imatinib Forrest D (BMT/VGH) Industry

Opened 06‐May‐2005, Status: Open CA180013

110. A phase III clinical trial of immunotherapy with humanized LL2 IGG (AMG 412) in subjects with low‐grade, follicular, b‐cell non‐hodgkin’s lymphoma refractory to Rituxan® (Rituximab) Connors J (VCC) Industry

Opened 07‐Nov‐2001, Status: Close LYTAM412

111. A phase III randomized study of cloretazine (vnp40101m) and ARAC in patients with acute myeloid leukemia in first relapse Hogge D (BMT/VGH) Industry

Opened: 15‐Sept‐2005, Status: Open CLI‐037

112. A phase III study of gemcitabine, dexamethasone, and cisplatin(gdp) compared to dexamethasone, cytaraine, and cisplatin (dhap) as salvage chemotherapy for patients with relapsed or refractory aggressive histology non‐hodgkinʹs lymphoma prior to autologous Sehn L (VCC) NCIC

Opened 24‐Feb‐2005, Status: Open LYLY12

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113. A pivotal phase II multicenter study of vincristine sulfate liposomes injection in diffuse large b‐cell non‐hodgkin’s lymphoma at second or later relapse Shenkier T (VCC)

Industry Opened 27‐Jul‐2001, Status: Closed LYTVSLI

114. A randomized phase III study of concurrent tretinoin and chemotherapy with or without arsenic trioxide (as2o3) (nsc#706363) as initial consolidation therapy followed by maintenance therapy with intermittent tretinoin versus intermittent tretinoin plus mercaptopurine for patients with untreated acute promyelocytic leukemia Nevill T (BMT/VGH) NCIC CTG/CALGB

Opened 19‐Feb‐2003; Status: Follow‐up AL.3 (Arsenic) (Protocol AML 00‐01)

115. A randomized, controlled, parallel‐group, multicenter study of extracorporeal photoimmune therapy with therakos* uvadex* for the treatment of patients with newly diagnosed acute graft‐versus‐host disease Hogge H (BMT/VGH) Industry

Opened Nov, 2006; Status: Open Acute‐GvHD‐1

116. A randomized controlled study of DOXIL/CAELYX and VELCADE or VELCADE monotherapy for the treatment of relapsed multiple myeloma Sutherland H (BMT/VGH) Industry

Opened 13‐Jul‐2006; Status: Follow‐up Doxil‐MMY‐3001

117. A randomized multi‐center open label study of bms‐354825 vs. imatinib mesylate (gleevec®) 800 mg/d in subjects with chronic phase philadelphia chromosome‐positive chronic myeloid leukemia who have disease that is resistant to imatinib at a dose at 400 ‐ 600 mg/d Forrest D (BMT/VGH) Industry

Opened 06‐May‐2005; status: Open CA180017

118. A randomized phase III trial of ABVD versus stanford V + radiation therapy in locally extensive and advanced stage hodgkinʹs disease with 0 ‐ 2 risk factors Connors J (VCC) NCIC

Opened 18‐Jun‐2002, Status: Follow‐up LYHD7

119. A randomized two‐arm, multicenter, open‐label phase II study of bms‐354825 administered orally at a dose of 70 mg twice daily or 140 mg once daily in subjects with cml in accelerated phase or in myeloid or lymphoid blast phase or with ph + acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate Forrest D (BMT/VGH) Industry

Opened 10‐Nov‐2005, Status: Follow up CA180035

120. A randomized two‐by‐two, multicenter, open‐label phase iii study of bms‐354825 administered orally at a dose of 50 mg or 70 mg twice daily or 100 mg or 140 mg once daily in subjects with chronic ph + chromosome or bcr‐abl positive cml who are resistant or intolerant to imatinib mesylate Forrest D (BMT/VGH) Industry

Opened 10‐Nov‐2005, Status: Closed CA180034

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121. An international single‐arm protocol to provide expanded access to VELCADE™ for patients with multiple myeloma who have received at least two previous lines of therapy and are refractory to or have relapsed after their last therapy for multiple myeloma Sutherland H (BMT/VGH) Industry

Opened 2004, Status: Follow‐up 26866138‐MMY‐3001

122. An open‐label, multicenter, dose‐escalating phase I/II trial of 3‐weekly rhuMAb 2H7 in patients with follicular non Hodgkin’s lymphoma Sehn L (VCC) Industry

Opened 16‐Nov‐2005, Status: Follow‐up LYTRHUMB

123. An open‐label, randomized, multicentre study comparing gleevec (imatinib) at doses of 400 mg and 800 mg in obtaining major molecular response in cml that have reached a compete cytogenetic response during 400 mg on gleevec Barnett M (BMT/VGH)

Industry Opened 14‐Jan‐2005, Status: Closed CSTI571ACA09

124. Compassionate use protocol for subjects with advanced cml and ph+ all (awaiting start‐up package from sponsor) Forrest D (BMT/VGH) Industry

Opened 24‐Oct‐2006, Status: Open BMS CA180‐033

125. Phase II open‐label study of amonafide l‐malate in combination with cytarabine in subjects with secondary acute myeloid leukemia Hogge D (BMT/VGH) Industry

Opened 12‐May‐2006, Status: Closed 0001A3‐200‐GL

126. Pilot study of cyclosporine pharmacokinetic monitoring in allogeneic BMT patients Nevill T (BMT/VGH) Grant Funded

Opened 15‐Oct‐2003, Status: Open SC‐02‐01

127. Randomized phase III study of thalidomide and prednisone as maintenance therapy following auto scat in patients with multiple myeloma Song K (BMT/VGH) NCIC

Opened 11‐Apr‐2003, status: open MY10

128. Safety, biological and clinical efficacy of two intensity levels of Theraflu extracorporeal photo chemotherapy in subjects with extensive chronic GvHD refractory or intolerant to standard therapy: a randomized, open‐label phase I/II clinical trial Hogge D (BMT/VGH) Industry

Opened 16‐Feb‐2006, Status: Open CR‐ECP‐001

129. Treatment with AMD3100 in non‐hodgkins’s lymphoma and multiple myeloma patients to increase the number of peripheral blood stem cells when given a mobilizing regimen of G CSF Smith C (BMT/VGH) Industry

Opened Jan‐2005, Status: Follow‐up AMD3100‐C201

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LUNG CANCER – NON‐SMALL CELL LUNG CANCER 130. A multi‐center, non‐randomized, open label safety study of BLP25 liposome vaccine (L‐BLP25) in

non‐small cell lung cancer (NSCLC) patients with unresectable stage III disease Murray N (VCC) Jasas K (FVC)

Industry Opened April 2005, Status: Follow‐up LUTB25LG

131. A multicentre, open label , phase II study of Velcade (Bortezomib) for injection in previously treated patients with stage IIIb and IV bronchioloalveolar carcinoma and adenocarcinoma with bronchioloalveolar features Murray N (VCC) Industry

Opened 20‐Feb‐06, Status: Active Tx LUTPEAK

132. A phase I‐II study of weekly OGX‐011 plus a Gemcitabine/platinum based regimen in patients with stage IIIB or IV non‐small cell lung cancer Lee C (FVC) Laskin J (VCC)

Industry Opened Nov‐2004, Status: Follow‐up LUTOGX11

133. A phase II multicentre randomised, parallel group, double‐blind, placebo‐controlled study of ZD1839 (Iressa) (250mg tablet) plus best supportive care (BSC) versus placebo plus BSC in chemotherapy‐naïve patients with advanced (STAGE IIIB OR IV) non‐small cell lung cancer Lee C (FVC) Industry

Opened 09‐Feb‐2005, Status: Closed AZ0711

134. A phase II study of SU011248 as consolidation therapy in patients with locally advanced or metastatic non‐small cell lung cancer Laskin J (VCC) Industry

Opened 11‐Jan‐2006, Status: Closed Tx LUT11248

135. A phase II trial of ACAPHA in former smokers with intraepithelial neoplasia Lam S (VCC) leRiche JC (VCC) MacAulay C (BCCRC)

NIH/NCI Opened 01‐Oct‐2002, Status: Follow‐up

136. A phase IIb randomized placebo controlled study of the safety and efficacy of Polyohenon E in smokers with bronchial dysplasia Lam, S (VCC) McWilliams (VCC) Ionescu D (VCC)

NIH/NCI Opened 2003, Status: Open C03‐0083

137. A phase III trial of Cisplatin/Etoposide/ radiotherapy with consolidation Docetaxel followed by maintenance therapy with ZD1839 or placebo in patients with inoperable locally advanced stage III non‐small cell lung cancer Fenton D (VCC) Sutherland J (CSI)

NCIC Opened Nov‐02, Status: Follow‐up LUBR15

138. A phase III randomized, double‐blind, placebo controlled trial of the epidermal growth factor receptor antagonist, ZD 1839 (Iressa) in completely resected primary NSCLC Laskin J (VCC) NCIC

Opened Jan‐2005, Status: Follow‐up LUBR19

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139. A pilot comparative study of the genomic, molecular and clinical profiles of patients with lung cancer, COPD or asthma, treated with Symbicort® Turbuhaler® Lam S (VCC) McWilliams A (VCC) Lam W (VCC)

Astra‐Zeneca Opened 2006, Status: Open D5892L00007

140. A prospective study to evaluate anemia and transfusion requirements in NSCLC patients with completely resected tumours undergoing adjuvant chemotherapy

Lee C (FVC) Melosky B (VCC) Rao S (CSI) Anderson H (VIC)

Ontario Cancer Control, Industry Opened Apr‐05, Status: Closed LEAD

141. A randomized double blind multi‐centre 2‐stage phase III study of Bevacizumab in combination with Cisplatin and Gemcitabine versus placebo, Cisplatin and Gemcitabine in patients with advanced or recurrent non‐squamous NSCLC who have not received prior chemotherapy Anderson H (VIC) Rao S (CSI)

Industry Opened Sep‐05, Status: Closed LUTBEVCG

142. A randomised, open‐label, parallel group, international multicenter, phase III study of oral ZD1839 (IRESSA®) versus intravenous docetaxel (Taxotere®) in patients with locally advanced or metastatic recurrent non‐small cell lung cancer who have previously chemotherapy Lee C (FVC) Industry

Opened 12‐Aug‐2004, Status: Open AZ0721

143. A randomized phase III study of docetaxel or pemetrexed with or without cetuximab in patients with recurrent or progressive non‐small cell lung cancer after platinum based therapy Murray N (VCC) Industry

Opened 30‐Oct‐06, Status: Open LUTDPC

144. An open label, randomized, multicenter, phase II study to determine the hemoglobin dose response, safety and pharmacokinetic profile of Ro 50‐3821 given subcutaneously once weekly or once every 3 weeks to anemic patients with stage IIIB or IV non‐small cell lung carcinoma receiving antineoplastic therapy Lee C (FVC) Melosky B (VCC)

Industry Opened 01‐Feb‐2004, Status: Closed NA17101b

145. Randomized, phase IIb trial of sulindac in smokers with bronchial dysplasia Lam S (VCC) McWilliams, A (VCC)

NIH/NCI Opened 2006, Status: Open May03‐1‐02

146. Understanding the correlation of clinical and biological predictors of response in a phase II study of Erlotinib (TarcevaTM) as first‐line treatment in patients with non‐small cell lung cancer Laskin J (VCC) Lee C (FVC)

BCCA, Industry Opened 13‐Sep‐06, Status: Open LUTERLOT

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LUNG CANCER – SMALL CELL LUNG CANCER 147. A phase II randomized, double‐blind, placebo controlled trial of ZD6474 vs. placebo in small cell

lung cancer patients who have complete or partial response to induction chemotherapy +/‐ radiation therapy Rao S (CSI)

NCIC and Industry Opened Jul‐03 None

148. A phase II study of ZD6474 or placebo in small cell lung cancer patients who have complete or partial response to induction chemotherapy ± radiation therapy Lee C (FVC) Fenton D (VCC)

NCIC Opened 30‐Mar‐2004, Status: Closed BR20

149. A phase II trial of Carboplatin and Irinotecan (cpt‐11) as first‐line therapy for patients with extensive stage small cell lung cancer (Protocol VIC THO 0321) Laskin J (VCC) Vanderbilt Univ

Opened 19‐Sep‐06, Status: Open LUTCAIRI

150. A randomized, double‐blind, placebo‐controlled study to evaluate the impact of maintaining haemoglobin levels using EPREX*/PROCRIT ( Epoetin alpha) in limited disease small cell lung cancer (LD SCLC) subjects receiving combined chemotherapy and radiation Melosky B (VCC) Industry

Opened 02‐Apr‐2002, Status: Closed LUTLEGCY

151. A randomized, phase III trial comparing CPT‐11(Irinotecan HCI; Camptosar TM Injection) / Cisplatin with Etoposide/Cisplatin in patients with previously untreated, extensive small cell lung cancer Martins H (VIC) Murray N (VCC)

Industry Opened 26‐Mar‐2002, Status: Closed LUTCPT11

MELANOMA 152. A phase II study of SB‐715992 (D‐21266; NSC 727990) in previously untreated patients with

metastatic or recurrent malignant melanoma Lee C (FVC) Savage K (VCC) Rao S (CSI)

NCIC Opened 01‐Apr‐2005, Status: Open IND 169

153. A phase III, open label, randomized, comparative study of tticilimumab and either dacarbazine or temozolomide in patients with advanced melanoma Savage K (VCC) Wilson K (VIC)

Industry Opened 23‐Jan‐07, Status: Open SMTTICTZ

154. A phase III randomized study of four weeks high dose IFN‐a2b in stage T3‐T4 or N1 (microscopic) melanoma Pansegrau G (FVC) Wilson K (VIC) Rao S (CSI) Savage K (VCC)

NCIC Opened Aug‐04, Status: Open ME10

155. A randomized study of dacarbazine versus dacarbazine plus G3139 (BCL‐2 antisense oligonucleotide) in patients with advanced malignant melanoma Klasa R (VCC) Industry

Opened 01‐Jul‐2001, Status: Follow‐up SMTG3139

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156. A randomized study of dacarbazine versus dacarbazine plus G3139 (BCL‐2 antisense oligonucleotide) in patients with advanced malignant melanoma (GM301) Lee C (FVC) Industry

Opened 12‐Feb‐2004, Status: Closed Genta

MESOTHELIOMA 157. An open‐label phase II trial of ZD1839 (Iressa ™ ) in patients with malignant mesothelioma

Lee C (FVC) Rao S (CSI) MacNeil M (VIC)

Industry Opened 30‐Sep‐2003, Status: Open LUTGEF

158. Expression of EGFR & VEGF in malignant pleural mesothelioma: defining potential therapeutics targets Lee C (FVC) MacNeil M (VIC) Rao S (CSI)

WCB/ Industry Opened 19‐Nov‐2002, Status: Open Immuno‐histochemistry

OVARIAN 159. A multi‐national, randomized, phase III, GCIC intergroup study comparing pegylated liposomal

doxorubicin (caelyx) and carboplatin vs. paclitaxel and carboplatin in patients with epithelial ovarian cancer in late relapse (>6 months): Gineco calypso study Lee U (FVC) Heywood M (VCC)

NCIC Opened 31‐Aug‐06, Status: Open OV17

160. A phase II evaluation of bevacizumab (anti‐VEGF humanized monoclonal antibody) in the treatment of persistent or recurrent epithelial ovarian primary peritoneal carcinoma Hoskins P (VCC) Other Govʹt Trial

Opened 27‐Feb‐2003, Status: Close GOG0170D

161. A phase II, open‐label, controlled, randomized, multicentre study to evaluate the efficacy and safety of pertuzumab (omnitarg), a recombinant humanized antibody against HER2, in combination with carboplatin‐based standard chemotherapy versus carboplatin‐based standard chemotherapy alone in patients with platinum sensitive recurrent ovarian cancer Swenerton K (VCC) Ellard S (CSI)

Industry Opened 10‐Feb‐2006, Status: Active Tx GOTPMABC

162. A phase II, open‐label, study of Caelyx and Carboplatin in intermediate platinum‐sensitive (6 to 12 months treatment free interval) relapsed epithelial ovarian cancer Lee U (FVC) Industry

Opened 04‐May‐2004, Status: Closed Schering

163. A phase II randomized study for focus: fragmin in ovarian cancer: utility on survival Lee U (FVC) Ontario Cancer Control

Opened 01‐Mar‐2006, Status: Open FOCUS

164. A phase II randomized study of fragmin in ovarian cancer: utility on survival Hoskins P (VCC) Ellard S (CSI)

OCOG Opened 09‐Feb‐2006, Status: Open GOTDALT

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165. A phase II study of OSI‐774 (NSC 718781) given in combination with Carboplatin in patients with recurrent epithelial ovarian cancer Ellard S (CSI) NCIC

Opened 21‐Aug‐2002, Status: Follow‐up GOIND149

166. A phase III study of cisplatin plus topotecan followed by paclitaxel plus carboplatin versus paclitaxel plus carboplatin as first line chemotherapy in women with newly diagnosed advanced epithelial ovarian cancer Lee U (FVC) Hoskins P (VCC) Taylor M (CSI)

NCIC Opened 01‐Feb‐2001, Status: Follow‐up OV16

167. An international phase III study comparing Gemcitabine plus Carboplatin vs Carboplatin monotherapy in patients with advanced epithelial ovarian carcinoma who failed first‐line platinum‐based therapy Chia S (VCC) NCIC

Opened 01‐Jun‐2001, Status: Closed GOOV15

168. An open‐label, multicenter, non‐comparative phase II study of the combination of intravenous Topotecan and Gemcitabine administered once weekly for three weeks every 28 days as second‐line treatment in patients with recurrent platinum‐sensitive ovarian ca Hoskins P (VCC) Industry

Opened 30‐Apr‐2003, Status: Closed GOTOVTG

169. An open‐label phase I/II dose escalation study evaluating the safety and efficacy of EPO906 in patients with advanced ovarian, primary fallopian, or primary peritoneal cancer. Protocol no Hoskins P (VCC) Industry

Opened 20‐Nov‐06, Status: Open GOTEP906

PHASE I CLINICAL TRIALS 170. A phase I, dose‐finding study of Rituximab in combination with recombinant human IL‐2 (L2‐7001,

a liquid formulation of Aldesleukin) for relapsed and refractory non‐Hodgkinʹs lymphoma Connors J (VCC) Industry

Opened 08‐Jan‐2003, Status: Active Tx LYTIL2R

171. A phase I dose‐finding trial of weekly docetaxel, gemcitabine and cisplatin for advanced urothelial cancer Chi K (VCC) Industry

Opened 11‐Dec‐2001, Status: Closed GUTDGC

172. A phase I, multi‐centre, open‐label, dose‐escalation study to evaluate the safety, tolerability and pharmacokinetics of HGS‐TR2J (fully human monoclonal antibody to the trail‐r2) in subjects with advanced solid malignancies Gelmon K (VCC) Industry

Opened 20‐Aug‐2004, Status: Open P1THTR2J

173. A phase I open label dose escalation study of Herzyme in patients with HER2 overexpressing cancers Gelmon K (VCC) Industry

Opened 03‐Aug‐2001, Status: Closed P1THERZY

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174. A phase I open‐label, multi‐center dose‐escalation study to determine the maximum tolerated dose (MTD) and dose limiting toxicity of gimatecan (LBQ707) administered in two different schedules in adult patients with advanced solid tumors Chia S (VCC)

Industry Opened 30‐Oct‐06, Status: Open P1TGIMAT

175. A phase I, open‐label, multiple dose study to assess the safety, tolerability and pharmacokinetics of arry‐334543 given on a daily oral regimen in patients with advanced cancer Kollmannsberger C (VCC) Industry

Opened 09‐Jan‐2006, Status: Open P1T0501

176. A phase I pharmacokinetic and pharmacodynamic study of weekly and twice weekly OSI‐774 Chia S (VCC) BCCA

Opened 25‐Oct‐2004, Status: Active Tx P1ERLOT

177. A phase I safety and pharmacokinetic/pharmacodynamic study of CP‐724,714 in patients with advanced malignant solid tumors that express HER2 Gelmon K (VCC) Industry

Opened 23‐Mar‐2004, Status: Closed P1TCP724

178. A phase I study of a second generation clusterin antisense oligonucleotide (OGX‐011) in combination with Docetaxel Chi K (VCC) NCIC

Opened 04‐Apr‐2003, Status: Follow‐up P1IND154

179. A phase I study of ABT‐751 in combination with Docetaxel in patients with metastatic hormone refractory prostate cancer Chi K (VCC) Le L (FVC) Ellard S (CSI) Michels J (VIC)

Industry Opened 01‐Mar‐2004, Status: Open P1TAB751 or ABT751

180. A phase I study of AEG35156 given as a 2 hour intravenous infusion in combination with Docetaxel in patients with solid tumours Chi K (VCC) NCIC

Opened 16‐Jun‐2005, Status: Follow‐up P1IND166

181. A phase I study of AEG35156 given as a 2 hour intravenous infusion in combination with Docetaxel in patients with solid tumours Chi K (VCC) NCIC

Opened 28‐Jul‐06, Status: Open P1IND166B

182. A phase I study of CCI‐779 in combination with carboplatin and paclitaxel in patients with advanced solid tumours Kollmannsberger C (VCC)

NCIC Opened 12‐Feb‐07, Status: Open P1IND179

183. A phase I study of combination neoadjuvant hormone therapy and weekly OGX‐011 (clusterin antisense oligonucleotide) prior to radical prostatectomy in patients with localized prostate cancer Chi K (VCC) NCIC

Opened 06‐Dec‐2002, Status: Closed P1IND153

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184. A phase I study of CPX‐1 (irinotecan hcl: floxuridine) liposome injection in patients with advanced solid tumors Gelmon K (VCC) Industry

Opened 07‐Jan‐2005, Status: Open P1TIRFXD

185. A phase I study Of G3139 antisense oligonucleotide (oblimersen) in combination with CHOP and Rituximab in untreated advanced stage diffuse large B cell lymphoma Klasa R (VCC) Sutherland J (CSI)

NCI/ NCIC Opened 30‐Jul‐2003, Status: Closed LYTG3139

186. A phase I study of dt388il3 fusion protein in patients with relapsed and refractory acute leukemia (AML)

Hogge D (BMT/VGH) Dr. Frankel, Scott & White Hospital, Texas Opened: 17‐June‐2005; Status: Open

187. A phase I study of MGCD0103 given as a three‐times weekly oral dose in patients with advanced solid tumors or non‐hodgkin’s lymphoma Gelmon K (VCC) Industry

Opened 17‐May‐2004, Status: Closed P1TMGCD

188. A phase I study of OC144‐093 in combination with paclitaxel in patients with cancer Chi K (VCC) Industry

Opened 01‐May‐2001, Status: Closed MOTONT06

189. A phase I study of safety and immunogenicity of ALVAC‐CEA/B7.1 Vaccine administered concurrently with chemotherapy or following chemotherapy In patients with stage III colorectal adenocarcinoma Lohrisch C (VCC) Industry

Opened 17‐Jan‐2003, Status: Closed GITAJVAC

190. A phase I study of the safety of myo‐inositol in smokers with bronchial dysplasia Lam S (VCC) McWilliams A (VCC) leRiche JC (VCC)

NIH/NCI Opened Jan 15, 2004, Status: Closed

SYMPTOM MANAGEMENT 191. A multicentre, open‐label, long‐term efficacy and safety continuation study of subcutaneous

tetrodotoxin (TectinTM) for moderate to severe cancer‐related pain Hawley P (VCC) Industry

Opened 26‐Aug‐2004, Status: Closed SCTTETOL

192. A multicenter, randomized, double‐blind, placebo‐controlled, parallel‐design trial of the efficacy and safety of sub‐cutaneous Tetrodotoxin (Tectin) for moderate to severe inadequately controlled cancer‐related pain Hawley P (VCC) Fyles G (CSI)

Industry Opened 26‐Aug‐2004, Status: Closed SCTTETRO

193. Double‐blind phase III, two‐week, placebo controlled study of Methylnaltrexone (MNTX) for relief of constipation due to opioid therapy in advanced medical illness Fyles G (CSI)

Industry Opened Aug‐04

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UTERUS 194. A phase II, open label, study of doxorubicin HCL liposome (caelyx) and carboplatin in utero‐

cervical malignancies Swenerton K (VCC)

Industry Opened 18‐Sep‐2001, Status: Closed GOTLDOXC

195. A phase II evaluation of thalidomide (nsc #66847) in the treatment of recurrent or persistent carcinosarcoma of the uterus Hoskins P (VCC) Other Govʹt Trial

Opened 24‐Dec‐2002, Status: Closed GOEND230

196. A phase II evaluation of thalidomide (nsc #66847) in the treatment of recurrent or persistent leiomyosarcoma of the uterus Hoskins P (VCC) Other Govʹt Trial

Opened 15‐Jan‐2003, Status: Closed GOEND231

197. A phase II study of CCI‐779 in patients with metastatic and/or locally advanced recurrent endometrial cancer Hoskins P (VCC) NCIC

Opened 26‐Oct‐2004, Status: Open GOIND160

198. A phase II study OSI‐774 (NSC 718781) in patients with locally advanced and/or metastatic carcinoma of the endometrium (uterus) Hoskins P (VCC) NCIC

Opened 03‐Dec‐2002, Status: Follow‐up GOIND148

OTHER CLINICAL TRIALS 199. A multicentre, randomised, double‐blind, placebo‐controlled study of darbepoetin alpha for the

treatment of anemia of cancer Hoskins P (VCC) Industry

Opened 11‐Jan‐2005, Status: Open SCTDA103

200. A multicentre, randomised, double‐blind, placebo‐controlled roll over study to protocol 20010103 of darbepoetin alpha for the treatment of anemia of cancer Hoskins P (VCC) Industry

Opened 25‐Oct‐2005, Status: Closed SCTDA149

201. A randomised, double blind study of front‐loading darbepoetin alpha compared with standard weekly administration for the treatment of anaemia in subjects with a non myeloid malignancy and receiving multicycle chemotherapy Hoskins P (VCC) Industry

Opened 23‐Apr‐2003, Status: Closed SCTDARBE

202. A randomized double blind placebo controlled study of darbepoetin alpha for the treatment of anemia in subjects with non‐myeloid malignancy receiving multicycle chemotherapy Hoskins P (VCC) Industry

Opened 25‐Jun‐2004, Status: Closed SCTDA232

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203. An open‐label, multicenter, randomized, comparative, phase III study to evaluate the efficacy and safety of Rituximab plus Fludarabine and Cyclophosphamide (FCR) versus Fludarabine and Cyclophosphamide alone (FC) in previously treated patients with CD20 p Hoskins P (VCC) Industry

Opened 29‐Sep‐2004, Status: Open LYTFCRFC

204. An open‐label phase IIa study in subjects with recurrent n‐cadherin positive advanced solid tumours to investigate the safety and efficacy of ADH‐1 administered intravenously as a single agent once every 3 weeks. adherex protocol number AHX‐01‐201 Chi K (VCC) Industry

Opened 20‐Jul‐06, Status: Open P2TADH1

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medical oncology - bc cancer includes a wide variety of phase i, ii, iii and iv clinical trials....

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