Conditions: Colorectal Neoplasms
Keywords: NSABP bevacizumab capecitabine oxaliplatin irinotecan rectal cancer colon cancer colorectal cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 7
Healthy volunteers: no

Brief summary:
Bevacizumab 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.

Detailed description:
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.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Bevacizumab intervention 2: Oxaliplatin intervention 3: Capecitabine intervention 4: Irinotecan
Intervention descriptions: intervention 1: 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. intervention 2: 130 mg/m2 IV Day 1 every 21 days for eight cycles intervention 3: 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 intervention 4: 200 mg/m2 IV Day 1 every 21 days for eight cycles

Protocol document: