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McG Studies

Gerald Bronfman Centre for Clinical Research in Oncology

Clinical Research Program

546 Pine Avenue West

Montreal, Quebec H2W 1S6

- McGill Studies List -

Period of January 2000 to Present

-McG 0001- [CZOL446 0702]

A Randomized, Placebo-Controlled Study on the Efficacy and Tolerability of Zometa in the Prevention of Disease Recurrence in Patients with Node Positive Primary Breast Cancer

Novartis

Dr. L. Panasci WITHDRAWN BY COMPANY

-McG 0002- [CA99002]

Pivotal Phase II Multicenter Study of Vincristine Sulfate Liposomes Injection in Diffuse Large B-Cell Non-Hodgkin’s Lymphoma at Second or Later Relapse

Inex TERMINATED

Dr. S. Caplan

-McG 0003- [195-301]

Phase III, Randomized, Multicenter Study to Assess the Efficacy and Safety of HuM195 (Recombinant Humanized Anti-CD33 Monoclonal Antibody) in Combination with Standardized Chemotherapy Compared to Standardized Chemotherapy Alone in the Treatment of Patients With Refractory or First-Relapsed Acute Myelogenous Leukemia (AML)

Theradex WITHDRAWN BY COMPANY

Dr. P. Laneuville

-McG 0004- [R115777-INT-11]

A Phase III Double-Blind, Placebo Controlled Trial of Gemcitabine Plus Placebo vs. Gemcitabine Plus R115777 in Chemonaive Patients with Advanced Pancreatic Cancer

Janssen-Ortho

Dr. A. Langleben/Beverly DeSalis TERMINATED

-McG 0005- [T99-0046]

Multicenter, Open-Ended, Double-Blind, Placebo-Controlled, Phase III Study of AE-941 in Addition to Combined Modality Treatment (Chemotherapy/Radiotherapy) For Locally Advanced Unresectable Non-Small Cell Lung Cancer

Aeterna

Dr. G.Batist/Ginette Ricard TERMINATED

-McG 0006- [PR96-27-031]

The Effects of PROCRIT (Epoetin alfa) on Hemoglobin, Symptom Distress and Quality of Life During Chemotherapy in Lymphoma, Chronic Lymphocytic Leukemia or Multiple Myeloma Patients with Mild to Moderate Anemia

Ortho Biotech WITHDRAWN

Dr. C. Shustik

-McG 0007- [M39021]

An Open-Label, Randomized, Multi-Center, Phase III Trial Comparing CVP + MabThera to Standard CVP Chemotherapy in Patients with Previously Untreated CD20 Positive Follicular Lymphoma (Stage III-IV)

Hoffman-LaRoche CLOSED

Dr. C. Shustik

-McG 0008- [RSR13 RT-009]

A Phase 3 Randomized, Open-Label, Comparative Study of Standard Whole Brain Radiation Therapy with or without RSR13 in Patients with Brain Metastases

Allos Therapeutics TERMINATED

Dr. K. Sultanem

-McG 0009- [104864/552]

A Phase II, Multicenter, Open-Label Study of Oral Topotecan and Cisplatin in Ovarian Cancer Recurring  6 Months Following Initial Platinum-Based Chemotherapy

SmithKline Beecham TERMINATED

(Dr. M. Trudeau) (Dr. A. Langleben) Dr. G. Stanimir

-McG 0010- [98-6475-183]

A Randomized, Open-Label, Multicenter, Phase III Study Study Comparing the Efficacy and Safety of Gemcitabine and Irenotecan HCI (CPT-11) to the Gemcitabine Alone in Patients with Locally Advanced or Metastatic Pancreatic Cancer who Have Not Received Prior Systemic Therapy

Pharmacia TERMINATED

(Dr. Trudeau) (Dr. A. Langleben) Dr. W. Miller

-McG 0011- [CSTI571 0106] “IRIS”

A Phase III Study of STI571 Versus Interferon-a (IFN-a) Combined with Cytarabine (ARA-C) in Patients with Newly Diagnosed Previously Untreated Philadelphia Chromosome Positive (PH+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Novartis CLOSED

Dr. C. Shustik

-McG 0011E- [STI571 0106 Extension]

An Extension Protocol for Patients who Progress to Accelerated Phase or Blast Crisis on the INF-a + Ara-C Treatment Arm of the Core Protocol

Novartis CLOSED

Dr. C. Shustik

-McG 0012- [H4Z-MC-JWXD]

Phase 3 Randomized Double-Blind Evaluation of LY353381 Compared with Tamoxifen in Women with Locally Advanced or Metastatic Breast Cancer

Eli Lilly TERMINATED

Dr. L.Panasci

-McG 0013- [N91-00-02-040]

A Randomized, Double-Blind, Placebo Controlled Comparison of the Analgesic Activity of Valdecoxib (SC-65872) 40mg BID as Add-on Therapy to Opioid Medication in Patients with Chronic Cancer Pain

Searle TERMINATED

Dr. B. Gagnon

-McG 0014- [-]

Phase II Multicenter Trial with Gemcitabine and Docetaxel in Patients with Advanced (Stage IIIB + IV) Non-Small Cell Lung Cancer

Aventis Pharma TERMINATED

Dr. V. Hirsh

-McG 0015- [1164.4]

A Phase III, Double-Blind, Randomized, Placebo-Controlled Study of Porfiromycin Used as an Adjuvant to Radiation Therapy in Postoperative Head and Neck Cancer Patients

Boehringer Ingelheim WITHDRAWN

-McG 0016- [9902]

A Phase III Multicenter, Randomized, Open-Label Trial Evaluating High Dose Melphalan plus Holmium-166-DOTMP versus High Dose Melphalan Alone when Given in Conjunction with Peripheral Blood Stem Cell Transplantation in Patients with Multiple Myeloma

NeoRx Corporation

Dr. C. Shustik INVESTIGATOR WITHDRAWN

-McG 0017- [1839IL/0017]

A Randomized, Double-Blind, Phase III Comparative Trial of 2 Doses of ZD1839 (IRESSA™) in Combination with Paclitaxel and Carboplatin versus Placebo in Combination with Paclitaxel and Carboplatin in Chemotherapy-Naïve Patients with Advanced (Stage III or IV) Non-Small Cell Lung Cancer

AstraZeneca TERMINATED

Dr. V. Hirsh

-McG 0018- [WO16229]

A Phase II Study of Herceptin Monotherapy Administered 3 Weekly in Women with HER2 Overexpression/Amplification in Metastatic Breast Cancer

Hoffmann La-Roche TERMINATED

Dr. L. Panasci

-McG 0019- [MEL06199]

A Phase I Study of Heterologous Prime-Boost Immunization by Intranodal or Subcutaneous Administration with Recombinant Canarypox Virus Expressing Tumour Antigen gp100 (Modified) Followed by Modified gp100 Peptide Combination in Melanoma

Aventis Pasteur Mérieux Connaught TERMINATED

Dr. S. Burdette-Radoux

-McG 0020- [GN301]

Randomized Study of Dacarbazine Versus Dacarbazine Plus G3139 (Bcl-2 Antisense Oligonucleotide) in Patients with Advanced Malignant Melanoma

Genta Incorporated TERMINATED

Dr. W. Miller

-McG 0020ext- [GM214]

Continuation Protocol for Genasense (G3139, Bcl-2 Antisense Oligonucleotide) and Dacarbazine in Patients with Malignant Melanoma Who to Responded to this Combination in GM301

Genta Incorporated TERMINATED

Dr. W. Miller

-McG 0021- [PRI/EPO-INT-76/EPO-CA-489]

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Impact of Maintaining Hemoglobin Using EPREX® (Epoetin Alpha; RWJPRI-22512) in Metastatic Breast Carcinoma Subjects Receiving Chemotherapy

Janssen-Ortho TERMINATED

Dr. M. Thirlwell

-McG 0022- [EPO CAN 20]

Randomized Trial of Epoetin Alpha in Patients with Advanced Non-Small Cell Carcinoma of the Lung

OCOG TERMINATED

Dr. B. Gagnon/Mary Ann Tasca

-McG 0023- [VIN20009]

A Phase II Multi-Centre Trial of Sequential Therapy with Vinorelbine and Gemcitabine in Patients with Stage IIIB + IV Non-Small Cell Lung Cancer (NSCLC) with Emphasis on the Elderly and Frail

Glaxo Wellcome CLOSED

Dr. Vera Hirsh

-McG 0024- [20010116]

A Phase 3 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)

Amgen TERMINATED

Dr. C. Shustik

-McG 0101- [CSTI571 0113]

An Expanded Access Protocol of STI571 in Patients with Chronic Myeloid Leukemia Who Are Hematologically or Cytogenetically Resistant or Refractory to Interferon-Alpha, or Intolerant of, Interferon-Alpha

Novartis TERMINATED

Dr. C. Shustik

-McG 0102- [CSTI571 0114]

An Expanded Access Protocol of STI571 in Adult Patients with Either Chronic Myeloid Leukemia in Accelerated Phase or Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Novartis TERMINATED

-McG 0103- [CSTI571 0115]

An Open-Label, Multicenter Expanded Access Study of STI571 in Patients with Either Chronic Myeloid Leukemia in Myeloid or Lymphoid Blast Crisis, or Philadelphia Chromosome-Positive Acute Myelogenous Leukemia

Novartis TERMINATED

Dr. C. Shustik

-McG 0104- [BCH-4556-214]

A Phase II Study of Troxatyl in Patients with CML Blastic Phase Disease

BioChem Pharma, Inc.

Dr. P. Laneuville COMPANY WITHDRAWN

-McG 0105- [Æ-MM-00-02]

Neovastat (Æ-941) in Refractory and Early Relapse Multiple Myeloma Patients

Æterna Laboratories, Inc.

Dr. C. Shustik TERMINATED

-McG 0106- [H3E-MC-JMEI(a)]

A Phase 3 Trial of ALIMTA vs Docetaxel in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Were Previously Treated with Chemotherapy

Eli Lilly

Dr. V. Hirsh/Sylvie Beaudoin TERMINATED

-McG 0107- [104864/557]

A Phase II Trial of Topotecan and Cisplatin in Patients with Metastatic or Recurrent Squamous Cell Carcinoma of the Cervix

SmithKline Beecham

(Dr. M. Trudeau) (Dr. A. Langleben) Dr. L. Souhami TERMINATED

-McG 0108- [CA163-013]

A Phase II Study of Epothilone Analog BMS-247550 in Patients with Metastatic Gastric Adenocarcinoma Previously Treated with a Fluoropyrimidine and/or a Platinum

Bristol-Myers Squibb

Dr. A. Langleben TERMINATED

-McG 0108-BC [CA163-022]

A Protocol to Collect Blood Samples for Pharmacogenomic Research from Patients Enrolled in a Clinical Trial of BMS-247550 Epothilone B Analog.

Bristol-Myers Squibb

Dr. A. Langleben WITHDRAWN BY COMPANY

-McG 0108-TC [CA163-016]

A Protocol to Collect a Tumour Tissue Sample for Pharmacogenomic Research from Patients Enrolled in a Clinical Trial of BMS-247550 Epothilone B Analog.

Bristol-Myers Squibb

Dr. A. Langleben WITHDRAWN BY COMPANY

-McG 0109- [401.00.001]

An Open Label, Randomized, Controlled, Phase III, Multi-center, Clinical Trial of PN401 with High Dose 5-Fluorouracil (5FU) versus Gemcitabine for Treatment of Patients with Advanced Pancreatic Cancer

Pro-Neuron, Inc.

Dr. W. Miller TERMINATED

-McG 0110- [B9E-CA-0312]

Phase I/II Multicenter Trial with Carboplatin and Gemcitabine Induction Chemotherapy, Followed by Radiotherapy Concomitantly with Low-Dose Weekly Paclitaxel and Gemcitabine for Patients with Stage IIIA + B Non-Small Cell Lung Cancer

Eli Lilly

Dr. V. Hirsh & Dr. M. Duclos CLOSED

-McG 0111- [TH9402/II/NHL/002]

Autologous TH9402 Purged Progenitor Cell transplantation for Non-Hodgkin’s Lymphoma

Theratechnologies Inc.

Dr. P. Laneuville TERMINATED

-McG 0112- [EPO-CAN-15]

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Impact of Maintaining Haemoglobin Levels Using EPREX*/PROCRIT® (Epoetin alfa) in Limited Disease Small Cell Lung Cancer (LD SCLC) Subjects Receiving Combined Chemotherapy and Radiation Therapy.

Ortho Biotech Inc. TERMINATED

Dr. V. Hirsh

-McG 0113- [GMY302]

Randomized Phase III Study of Dexamethasone With or Without Genasense™ 9Bcl-2 Antisense Oligonucleotide) in Patients with Relapsed or Refractory Multiple Myeloma

Genta TERMINATED

Dr. C. Shustik

-McG 0114- [RPI0003]

A Phase II, Open-Label, Multi-Center Trial of Angiozyme in Combination with 5-FU, Leucovorin and Irinotecan in Subjects with Metastatic Colorectal Cancer

Ribozyme Pharmaceuticals TERMINATED

Dr. W. Miller

-McG 0114ext- [RPI0102]

A Phase II, Open-Label, Multicenter Trial of Angiozyme in Subjects With Metastatic Colorectal Cancer Who Have Completed RPI0003

Ribozyme Pharmaceuticals TERMINATED

Dr. W. Miller

-McG 0115- [EFC4585]

A Multicenter, Open-label, Randomized, Two-Arm Study of Irinotecan (CPT-11) Versus the Combination of Oxaliplatin + Irinotecan (CPT-11) as Second-Line Treatment of Metastatic Colorectal Carcinoma

Sanofi-Synthelabo TERMINATED

Dr. W. Miller

-McG 0116- [88951A-PRT031

A Randomized, Open-Label, Multicenter Phase III Study Comparing the Efficacy and Safety of a Combination of Intravenous DX-8951f (Exatecan Mesylate) Plus Gemcitabine to Gemcitabine Alone in Patients with Locally Advanced or Metastatic Cancer of the Exocrine Pancreas Who Have Not Received Prior Chemotherapy

Daiichi TERMINATED

Dr. M. Thirlwell

-McG 0117- [R115777-INT-17]

A Phase 2 Study Evaluating the Efficacy of the Farnesyl Transferase Inhibitor (FTI) R115777 in Patients with Refractory or Elapsed Acute Myeloid Leukemia (AML)

Janssen Research Fdn. TERMINATED

Dr. C. Shustik

-McG 0118- [COL14]

Pilot Phase II Study of Safety and Immunogenicity of an Alvac-CEA/B7.1 Vaccine Administered Either Subcutaneously or Intranodally, Concurrently with Chemotherapy, in Patients with Metastatic Colorectal Adenocarcinoma.

Aventis

Dr. A. Langleben WITHDRAWN BY COMPANY

-McG 0119- [EFC 4584]

A Multicenter, Open-Label, Randomized, Three-Arm Study of 4-Fluorouracil (5-FU) Plus Leucovorin (LV) or Oxaliplatin or a Combination or 5-FU/LV + Oxaliplatin as Second-Line Treatment of Metastatic Colorectal Carcinoma.

Sanofi TERMINATED

Dr. W. Miller

-McG 0120- [440E-ONC-0020-262]

A Randomized, Phase III Trial Comparing CPT-11 (Irinotecan HCI; Camptosar Injection) Cisplatin with Etoposide in Patients with Previously Untreated, Extensive, Small-Cell Lung Cancer

Pharmacia TERMINATED

Dr. V. Hirsh

-McG 0121- [EPO906A2203]

An Open-Label Phase IIA Trial Evaluating the Safety and Efficacy of EPO906

in Patients with Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer

Novartis WITHDRAWN

Dr. M. Trudeau

-McG 0122- [PO2565]

A Phase II, Open-Label Study of Interferon alfa-2b in Combination with SCH 66336 in Patients with Metastatic Renal Cell Cancer

Schering TERMINATED

Dr. S. Tanguay

-McG 0123- [TNP-470]

A Phase II Study Comparing TNP-470/Paclitaxel/Carboplatin Combinations to Paclitaxel/Carboplatin Alone for Treatment of Non-Small Cell Lung Cancer

TAP Pharmaceuticals

Dr. A. Langleben WITHDRAWN BY COMPANY

-McG 0124- [BO16411]

A Randomised, Double-Blind, Placebo Controlled, Multicentre, Phase III Study of Tarceva Plus Chemotherapy (Cisplatin and Gemcitabine) Versus Chemotherapy Alone in Patients with Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Chemotherapy

Hoffmann-La Roche TERMINATED

Dr. V. Hirsh

-McG 0124 RG-

Roche Sample Repository Research Project in Conjunction with Hoffman-LaRoche Protocol Entitled: “A Randomised, Double-Blind, Placebo Controlled, Multicentre, Phase III Study of Tarceva Plus Chemotherapy (Cisplatin and Gemcitabine) Versus Chemotherapy Alone in Patients with Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Chemotherapy”

Hoffmann-La Roche

Dr. V. Hirsh TERMINATED

-McG 0125- [0473IL/0016]

A Multicentre, Open-Label, Randomized, Parallel-Group Study Evaluating the Efficacy and Tolerability of ZD0473 Versus Doxorubicin HCl liposome injection (Doxil™, Caelyx™) in Patients with Refractory Advanced Epithelial Ovarian Cancer in Whom Both Platinum- and Paclitaxel-Based Chemotherapy Regimens Have Failed

AstraZeneca WITHDRAWN BY COMPANY

Dr. M. Trudeau

-McG 0126- [5416.035]

A Phase III, Randomized, Open-Label, Multicenter, International Study Comparing the Combination of SU5416/Irinotecan/5-Fluorouracil/Leucovorin versus Irinotecan/5-Fluorouracil/Leucovorin Alone as First-Line Therapy of Patients With Previously Untreated Metastatic Colorectal Cancer

Sugen/Pharmacia WITHDRAWN BY COMPANY

Dr. A. Langleben

-McG 0127- [971-ONC-0028-057]

A Pilot, Open-Label, Randomized, Comparative Study of Exemestane Versus Anastrozole in Post-Menopausal Breast Cancer Patients With Visceral Disease

Pharmacia TERMINATED

Dr. M. Thirlwell

-McG 0128- [P01848]

Phase II Multi-Centre Trial of Caelyx™ in Combination with Herceptin® in Her-2 Over-expressing Advanced Breast Cancer

Schering TERMINATED

Dr. L. Panasci

-McG 0129- [PC4]

A Prospective, Randomised, Controlled, Double-Blind, Multinational, Multi-Centre Study of G17DT Immunogen in Combination With Gemcitabine in Previously Untreated Subjects With Locally Advanced (Nonresectable Stage II and III), Recurrent Disease Following Primary Resection, or Metastatic (Stage IV) Adenocarcinoa of the Pancreas

Orion

Dr. W.Miller TERMINATED

-McG 0130- -See McG 0202 [MP-8899-0104]

A Phase III Multi-Centre Controlled Trial with Stratified Randomization Comparing the Efficacy of Interleukin-2 (IL-2) plus Histamine Dihydrochloride (HDC) versus IL-2 Alone to Increase the Duration of Survival in Patients with AJCC Stage IV Malignant Melanoma with Hepatic Metastases

Maxim Pharmaceuticals, Inc.

Dr. S. Burdette-Radoux WITHDRAWN

-McG 0131- [Biomed 777-CLP-29]

Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer

BioMedicines, Inc. TERMINATED

Dr. W. Miller

-McG 0201- [RSR13 RT-012]

A Phase I/II Study to Evaluate the Safety, Tolerance, and Efficacy of RSR13 Administered to Patients Receiving a Course of Cisplatin and Radiation Therapy for Locally Advanced Carcinoma of the Cervix