Conditions: Colorectal Cancer
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 75
Healthy volunteers: no

Brief summary:
This open-label single arm study will evaluate the efficacy and safety of Avastin added to XELOX or FOLFOX in patients with metastatic colorectal cancer and disease progression on 1st line therapy with FOLFIRI plus Avastin. Patients will receive either Avastin (7.5mg/kg iv infusion every 3 weeks) and standard XELOX (Xeloda \[capecitabine\] plus oxaliplatin) chemotherapy or Avastin (5 mg/kg iv infusion every 2 weeks) and standard FOLFOX (5-FU and leucovorin plus oxaliplatin) chemotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: fluorouracil (5FU) intervention 2: leucovorin intervention 3: bevacizumab [Avastin] intervention 4: capecitabine [Xeloda] intervention 5: oxaliplatin
Intervention descriptions: intervention 1: standard FOLFOX regimen intervention 2: standard FOLFOX regimen intervention 3: 7.5 mg/kg iv infusion every 3 weeks OR 5 mg/kg iv infusion every 2 weeks intervention 4: standard XELOX regimen intervention 5: standard XELOX or FOLFOX regimen

Protocol document: