Title
Study of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Course of Treatment for Patients With Colorectal Cancer That Has Spread Beyond the Colon
Randomized Phase II Clinical Trial of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Line Treatment for Metastatic Colorectal Cancer
Phase
Phase 2Lead Sponsor
NSABP FoundationStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Colorectal NeoplasmsIntervention/Treatment
irinotecan bevacizumab capecitabine oxaliplatin ...Study Participants
7Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy works to kill cancer cells directly. This study is being done to see how colorectal cancer responds to treatment with the combination of bevacizumab and chemotherapy.
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.
7.5 mg/kg IV Day 1 every 21 days for eight cycles* *For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression.
130 mg/m2 IV Day 1 every 21 days for eight cycles
850 mg/m2 po BID Days 1-14 every 21 days for eight cycles*# *For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression. #For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID
200 mg/m2 IV Day 1 every 21 days for eight cycles
Inclusion Criteria: Pathological diagnosis of colon or rectal cancer from either the colon or rectum or a metastatic site (beyond the colon or rectum) Evidence of adequate organ function (such as liver, kidneys, etc.) Exclusion Criteria: Diagnosis of anal cancer Patients who are candidates for surgery Patients who have received previous treatments Pregnant or lactating women History of chronic disease(s) or other serious medical conditions
| Event Type | Organ System | Event Term |
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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.
