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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
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
NSABP Operations Center
Pittsburgh, Pennsylvania, United States
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.
Time frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Objective Response Rate
Time frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Toxicity - Adverse Events
Time frame: Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab
Overall Survival
Time frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Duration of Response
Time frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
200 mg/m2 IV Day 1 every 21 days for eight cycles