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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: | Open Label, Parallel Assignment, Randomized, Safety/Efficacy Study, Treatment |
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 | |
SHANGHAI, China, 200003 | |
SHANGHAI, China, 200080 | |
TIANJIN, China, 300060 | |
CHONGQING, China, 400042 | |
QINGDAO, China, 266003 | |
NANJING, China, 210002 |
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: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00642577 History of Changes |
Health Authority: | China: Ministry of Health |
Antimetabolites Vitamin B Complex Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Irinotecan Disease Progression Leucovorin Trace Elements Bevacizumab Intestinal Diseases Angiogenesis Inhibitors |
Immunosuppressive Agents Rectal Diseases Intestinal Neoplasms Folic Acid Digestive System Diseases Vitamins Fluorouracil Gastrointestinal Neoplasms Micronutrients Antineoplastic Agents, Phytogenic Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Irinotecan Colonic Diseases Physiological Effects of Drugs Leucovorin Bevacizumab Rectal Diseases Neoplasms by Site Vitamins Therapeutic Uses |
Growth Inhibitors Angiogenesis Modulating Agents Micronutrients Digestive System Neoplasms Vitamin B Complex Growth Substances Enzyme Inhibitors Intestinal Diseases Angiogenesis Inhibitors Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil |