CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
bevacizumab +3 morebiological
Likely dose
bevacizumab 10 mg/kgfrom 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/NCT00416494
NCT00416494Phase 2Completed

Phase II Study of Oxaliplatin, Capecitabine and Bevacizumab in the Treatment of Metastatic Colorectal Cancer

Herbert Hurwitz, MD·interventional·Posted Dec 28, 2006·Updated Sep 3, 2014

In Brief

A Phase 2 clinical trial evaluating bevacizumab, oxaliplatin, and 1 other intervention for Colorectal Cancer. Completed, enrolled 50 participants.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine and oxaliplatin together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with bevacizumab works in treating patients with metastatic or recurrent colorectal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 28, 2006
Enrollment StartSep 1, 2003
Primary CompletionJan 1, 2008
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 19.5 years ago

Interventions

bevacizumabbiological

10 mg/kg intravenously over 30-90 minutes on day 1

oxaliplatindrug

85 mg/m2 intravenously over 2 hours on day 1.

Capecitabinedrug

Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort

Capecitabinedrug

Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort