At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed metastatic or inoperable locally advanced colorectal cancer
- ✓At least one measurable target lesion by imaging
- ✕Prior systemic chemotherapy for advanced or metastatic disease
- ✕Prior bevacizumab treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-label Study of the Effect of 2 Different Treatment Schedules of Xeloda With Eloxatin and Avastin on Progression-free Survival in Treatment-naïve Patients With Locally Advanced or Metastatic Colorectal Cancer
In Brief
A Phase 2 clinical trial evaluating capecitabine, Oxaliplatin, and 1 other intervention for Colorectal Cancer. Completed, enrolled 435 participants.
Detailed 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.
Study Details
Timeline
Interventions
850 mg/m\^2 po bid on Days 1-14 of each 3-week cycle
130 mg/m\^2 IV on Day 1 of each 3-week cycle
7.5 mg/kg IV on Day 1 of each 3-week cycle
1500 mg/m\^2 po bid on Days 1-7 of each 2-week cycle
85 mg/m\^2 IV on Day 1 of each 2-week cycle
5 mg/kg IV on Day 1 of each 2-week cycle