Conditions: Colorectal Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 435
Healthy volunteers: no

Brief summary:
This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients were randomized to receive either: 1) Xeloda 850 mg/m\^2 orally twice a day (po bid) on Days 1-14, oxaliplatin 130 mg/m\^2 IV on Day 1, and Avastin 7.5 mg/kg IV on Day 1 of each 3-week cycle; or 2) Xeloda 1500 mg/m\^2 po bid on Days 1-7, oxaliplatin 85 mg/m\^2 IV on Day 1 and Avastin 5 mg/kg IV on Day 1 of each 2-week cycle. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: capecitabine intervention 2: Oxaliplatin intervention 3: bevacizumab intervention 4: capecitabine intervention 5: Oxaliplatin intervention 6: bevacizumab
Intervention descriptions: intervention 1: 850 mg/m\^2 po bid on Days 1-14 of each 3-week cycle intervention 2: 130 mg/m\^2 IV on Day 1 of each 3-week cycle intervention 3: 7.5 mg/kg IV on Day 1 of each 3-week cycle intervention 4: 1500 mg/m\^2 po bid on Days 1-7 of each 2-week cycle intervention 5: 85 mg/m\^2 IV on Day 1 of each 2-week cycle intervention 6: 5 mg/kg IV on Day 1 of each 2-week cycle

Protocol document: