Conditions: Colorectal Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 40
Healthy volunteers: no

Brief summary:
This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.

Detailed description:

Arms:
arm 1: Participants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.

Interventions: intervention 1: 5-Fluorouracil intervention 2: Bevacizumab intervention 3: Irinotecan intervention 4: Oxaliplatin
Intervention descriptions: intervention 1: Intravenous 5-fluorouracil based chemotherapy will be administered until disease progression or until termination of the study. The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor. intervention 2: Bevacizumab will be administered IV 5 mg/kg every 2 weeks until disease progression or until termination of the study. intervention 3: Irinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study. intervention 4: Oxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study.

Protocol document: