Conditions: Colorectal Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 168
Healthy volunteers: no

Brief summary:
This expanded access study will assess the safety and efficacy of intravenous bevacizumab (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum. The anticipated time on study treatment is 3-12 months.

Detailed description:

Arms:
arm 1: Bevacizumab will be administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.

Interventions: intervention 1: Bevacizumab intervention 2: Fluoropyrimidine-based Chemotherapy
Intervention descriptions: intervention 1: 5 mg/kg bevacizumab administered intravenously every 2 weeks or 7.5 mg/kg bevacizumab administered intravenously every 3 weeks according to the standard chemotherapy regimen. intervention 2: Fluoropyrimidine-based chemotherapy administered according to standard of care.

Protocol document: