At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open Label Trial to Assess the Steady State Pharmacokinetics of Avastin Given With Either XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer
In Brief
A Phase 3 clinical trial evaluating bevacizumab [Avastin], XELOX, and 1 other intervention for Colorectal Cancer. Completed, enrolled 64 participants across 7 sites in 3 countries.
Detailed Summary
This 2 arm study will compare the pharmacokinetics and safety of Avastin at steady state under 2 different dosing regimens, in combination with XELOX (oxaliplatin + Xeloda) or FOLFOX-4 (oxaliplatin, leucovorin and 5-fluorouracil). Patients randomized to the XELOX arm will receive Avastin (7.5mg/kg iv) on Day 1 of each 3 week cycle; patients randomized to the FOLFOX-4 arm will receive Avastin (5mg/kg iv) on Day 1 of each 2 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
Study Details
Timeline
Interventions
7.5mg/kg iv on day 1 of each 3 week cycle
As prescribed
5mg/kg iv on day 1 of each 2 week cycle
As prescribed