Conditions: Colorectal Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 41
Healthy volunteers: no

Brief summary:
This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: capecitabine [Xeloda] intervention 2: capecitabine [Xeloda] intervention 3: bevacizumab [Avastin] intervention 4: oxaliplatin intervention 5: irinotecan
Intervention descriptions: intervention 1: 1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle intervention 2: 1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle intervention 3: 5 mg/kg taken intravenously on Day 1 of each 2 week cycle intervention 4: 85 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles intervention 5: 135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles

Protocol document: