Randomized Phase II Clinical Trial of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Line Treatment for Metastatic Colorectal Cancer
Due to greater patient convenience and favorable toxicity profiles, clinical practice has
seen an increased use of the combinations of capecitabine with oxaliplatin (CAPOX) and
capecitabine with irinotecan (CAPIRI). Given the data documenting the improved efficacy for
5-FU based chemotherapy in combination with bevacizumab, it is important to investigate the
potential advantages of adding this agent to regimens containing capecitabine.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
One-year Progression-free Survival (PFS)
Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Norman Wolmark, MD
NSABP Foundation, Inc.
United States: Food and Drug Administration
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