Conditions: Colorectal Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 820
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of adding bevacizumab to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus bevacizumab. Participants will receive chemotherapy alone, or in combination with bevacizumab. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after stopping chemotherapy.

Detailed description:

Arms:
arm 1: Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal arm 2: Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal

Interventions: intervention 1: Chemotherapy intervention 2: Bevacizumab
Intervention descriptions: intervention 1: As prescribed intervention 2: Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle.

Protocol document: