At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-arm Open-label Phase II Study: Treatment Beyond Progression by Adding Bevacizumab to XELOX or FOLFOX Chemotherapy in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI + Bevacizumab Combination
In Brief
A Phase 2 clinical trial evaluating fluorouracil (5FU), leucovorin, and 3 other interventions for Colorectal Cancer. Completed, enrolled 75 participants across 28 sites.
Detailed 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.
Study Details
Timeline
Interventions
standard FOLFOX regimen
standard FOLFOX regimen
7.5 mg/kg iv infusion every 3 weeks OR 5 mg/kg iv infusion every 2 weeks
standard XELOX regimen
standard XELOX or FOLFOX regimen