Abstract
We planned a multicenter randomized phase III study to evaluate the efficacy of appropriate dose of bevacizumab (5 or 10 mg/kg) with FOLFIRI in patients with advanced/metastatic colorectal cancer who have failed prior bevacizumab plus oxaliplatin-based therapy. The primary endpoint is progression-free survival. The secondary endpoints are the toxicity, response rate, time to treatment failure, overall survival, overall survival from the start of the first-line treatment and second progression-free survival (time duration from the initiation of the first-line treatment until progression after the protocol treatment). A total of 370 patients were considered to be appropriate for this trial.
Publication types
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Clinical Trial, Phase III
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Multicenter Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Adult
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Aged
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Angiogenesis Inhibitors / administration & dosage*
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Antibodies, Monoclonal, Humanized / administration & dosage*
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Antineoplastic Combined Chemotherapy Protocols / administration & dosage
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Bevacizumab
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Camptothecin / administration & dosage
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Camptothecin / analogs & derivatives
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Colorectal Neoplasms / drug therapy*
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Colorectal Neoplasms / pathology*
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Disease Progression
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Disease-Free Survival
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Drug Administration Schedule
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Female
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Fluorouracil / administration & dosage
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Humans
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Leucovorin / administration & dosage
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Male
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Middle Aged
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Neoplasm Staging
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Organoplatinum Compounds / administration & dosage
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Oxaliplatin
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Patient Selection
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Treatment Failure
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Treatment Outcome
Substances
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Angiogenesis Inhibitors
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Antibodies, Monoclonal, Humanized
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Organoplatinum Compounds
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Oxaliplatin
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Bevacizumab
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Leucovorin
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Fluorouracil
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Camptothecin