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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00642577 |
This 2 arm study will assess the efficacy and safety of Avastin in combination with irinotecan + 5-fluorouracil/folinic acid, versus irinotecan + fluorouracil/folinic acid alone, as first line treatment in Chinese patients with metastatic colorectal cancer. Patients will be randomized 2:1 to receive 6-weekly cycles of Avastin (5mg/kg iv every 2 weeks) + irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks, or 6-weekly cycles of irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks. The anticipated time on study treatment is until disease progression, and the sample size is 100-500 individuals.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: bevacizumab [Avastin] Drug: irinotecan Drug: leucovorin Drug: fluorouracil |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open Label Study to Compare the Effect of First-Line Treatment With Avastin in Combination With Irinotecan + 5-Fluorouracil/Folinic Acid, and Irinotecan + 5-Fluorouracil/Folinic Acid Alone, on Progression-Free Survival in Chinese Patients With Metastatic Colorectal Cancer. |
Estimated Enrollment: | 210 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | December 2009 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: bevacizumab [Avastin]
5mg/kg iv every 2 weeks
Drug: irinotecan
125mg/m2 iv weekly for 4 weeks of each 6 week cycle
Drug: leucovorin
20mg/m2 iv weekly for 4 weeks of each 6 week cycle
Drug: fluorouracil
500mg/m2 iv weekly for 4 weeks of each 6 week cycle
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2: Active Comparator |
Drug: irinotecan
125mg/m2 iv weekly for 4 weeks of each 6 week cycle
Drug: leucovorin
20mg/m2 iv weekly for 4 weeks of each 6 week cycle
Drug: fluorouracil
500mg/m2 iv weekly for 4 weeks of each 6 week cycle
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China | |
GUANGZHOU, China, 510060 | |
GUANGDONG, China, 510515 | |
WUHAN, China, 430030 | |
BEIJING, China, 100036 | |
BEIJING, China, 100021 | |
BEIJING, China, 100071 | |
NANJING, China, 210002 | |
SHANGHAI, China, 200080 | |
TIANJIN, China, 300060 | |
CHONGQING, China, 400042 | |
QINGDAO, China, 266003 | |
SHANGHAI, China, 200003 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | BO20696 |
Study First Received: | March 19, 2008 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00642577 |
Health Authority: | China: Ministry of Health |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Irinotecan Disease Progression Leucovorin Bevacizumab |
Intestinal Diseases Rectal Diseases Intestinal Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Growth Inhibitors Angiogenesis Modulating Agents Micronutrients Antineoplastic Agents, Phytogenic |