At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Expanded Access Program of AvastinTM (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum
In Brief
A Phase 4 clinical trial evaluating 5-Fluorouracil, Bevacizumab, and 2 other interventions for Colorectal Cancer. Completed, enrolled 40 participants across 8 sites.
Detailed Summary
This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.
Study Details
Timeline
Interventions
Intravenous 5-fluorouracil based chemotherapy will be administered until disease progression or until termination of the study. The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor.
Bevacizumab will be administered IV 5 mg/kg every 2 weeks until disease progression or until termination of the study.
Irinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study.
Oxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study.