CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 90 enrolled
Drug / intervention
bevacizumab [Avastin] +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01135498
NCT01135498Phase 2Completed

An Open-label Study of the Effect of First-line Treatment With Avastin+Xelox, Followed by Avastin+Tarceva, on Progression-free Survival in Patients With Metastatic Colorectal Cancer

Hoffmann-La Roche·interventional·Posted Jun 2, 2010·Updated Feb 6, 2015

In Brief

A Phase 2 clinical trial evaluating bevacizumab [Avastin], eloxatin, and 2 other interventions for Colorectal Cancer. Completed, enrolled 90 participants across 12 sites.

Detailed Summary

This study will evaluate the efficacy and safety of a first-line regimen of Avastin and Xelox (Xeloda + Eloxatin) followed by Avastin and Tarceva, in patients with metastatic colorectal cancer. Patients will receive 6 x 21 day cycles of treatment with Avastin (7.5mg/kg iv on day 1), Xeloda (1000mg/m2 po twice daily on days 1 to 14) and Eloxatin (130mg/m2 iv on day 1). Patients free of disease progression will then continue with Avastin (7.5mg/kg iv once every 3 weeks) and Tarceva (150mg po daily). The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2, 2010
Enrollment StartNov 1, 2006
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 16.1 years ago

Interventions

bevacizumab [Avastin]drug

Intravenous repeating dose

eloxatindrug

Intravenous repeating dose

capecitabine [Xeloda]drug

Oral repeating dose

erlotinib [Tarceva]drug

Oral repeating dose