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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00278889 |
The primary purpose of this study is to compare the efficacy of AZD2171 in combination with FOLFOX to the efficacy of bevacizumab in combination with FOLFOX, in the second-line treatment of patients with metastatic colorectal cancer
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Drug: AZD2171 Drug: 5-fluorouracil Drug: Leucovorin Drug: Oxaliplatin Drug: Bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Study to Compare the Efficacy of AZD2171 in Combination With 5-Fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX) and the Efficacy of Bevacizumab in Combination With FOLFOX in the Second-Line Treatment of Patients With Metastatic Colorectal Cancer |
Enrollment: | 215 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Bevacizumab + FOLFOX
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Drug: 5-fluorouracil
intravenous infusion
Drug: Leucovorin
intravenous infusion
Drug: Oxaliplatin
intravenous infusion
Drug: Bevacizumab
intravenous infusion
|
2: Experimental
AZD2171 + FOLFOX
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Drug: AZD2171
oral tablet
Drug: 5-fluorouracil
intravenous infusion
Drug: Leucovorin
intravenous infusion
Drug: Oxaliplatin
intravenous infusion
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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:
Study Director: | AstraZeneca AZD2171 Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | D8480C00041, EUDRACT number 2005-003443-31, HORIZON I |
Study First Received: | January 17, 2006 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00278889 |
Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines |
Colorectal Cancer phase II metastatic colorectal cancer AZD2171 RECENTIN |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Leucovorin Bevacizumab Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Oxaliplatin 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 Angiogenesis Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Growth Inhibitors Angiogenesis Modulating Agents Micronutrients |