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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00109226 |
This Phase II, multicenter, double-blind, randomized, active-controlled trial is designed to evaluate the efficacy and safety of rhuMAb VEGF (Avastin) when administered at a dose of 5 mg/kg every 2 weeks in combination with 5 FU (fluorouracil)/leucovorin versus 5 FU/leucovorin alone in subjects with previously untreated metastatic colorectal cancer who are not optimal candidates to receive first-line CPT-11 (irinotecan). A total of 48 doses of rhuMAb VEGF may be administered during this study (maximum of 96 weeks of therapy).
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Drug: Avastin (Bevacizumab) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Safety/Efficacy Study |
Official Title: | A Phase II, Multicenter, Double-Blind, Randomized, Active-Controlled Clinical Trial to Evaluate the Efficacy and Safety of rhuMAb VEGF (Bevacizumab), a Recombinant Humanized Monoclonal Antibody to Vascular Endothelial Growth Factor, in Combination With 5-Fluorouracil and Leucovorin Chemotherapy in Subjects With Metastatic Colorectal Cancer Who Are Not Optimal Candidates for First Line CPT-11 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix H), serious cardiac arrhythmia requiring medication, or Grade II or greater peripheral vascular disease within
1 year prior to Day 0
Study ID Numbers: | AVF2192g |
Study First Received: | April 26, 2005 |
Last Updated: | September 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00109226 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Metastatic Colorectal Cancer Cancer |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Irinotecan Leucovorin Bevacizumab Folinic Acid Endothelial Growth Factors Intestinal Diseases Angiogenesis Inhibitors |
Rectal Diseases Intestinal Neoplasms Antibodies, Monoclonal Antibodies Digestive System Diseases Fluorouracil Mitogens Gastrointestinal Neoplasms Colorectal Neoplasms Immunoglobulins |
Digestive System Neoplasms Antineoplastic Agents Gastrointestinal Diseases Growth Substances Physiological Effects of Drugs Colonic Diseases Bevacizumab Intestinal Diseases Rectal Diseases Angiogenesis Inhibitors |
Pharmacologic Actions Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Growth Inhibitors Angiogenesis Modulating Agents Colorectal Neoplasms |