CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 509 enrolled
Drug / intervention
bevacizumab +4 morebiological
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/NCT00719797
NCT00719797Phase 3Completed

A PHASE III RANDOMIZED TRIAL OF FOLFOXIRI + BEVACIZUMAB VERSUS FOLFIRI + BEVACIZUMAB AS FIRST- LINE TREATMENT FOR METASTATIC COLORECTAL CANCER

Gruppo Oncologico del Nord-Ovest·interventional·Posted Jul 22, 2008·Updated Mar 11, 2015

In Brief

A Phase 3 clinical trial evaluating bevacizumab, fluorouracil, and 3 other interventions for Colorectal Cancer. Completed, enrolled 509 participants across 44 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, oxaliplatin, leucovorin, and fluorouracil, 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 block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with bevacizumab may kill more tumor cells. PURPOSE: This randomized phase III trial is comparing two combination chemotherapy regimens given together with bevacizumab to see how well they work as first-line therapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

Study Details

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

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 22, 2008
Enrollment StartJul 1, 2008
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.9 years ago

Interventions

bevacizumabbiological

Given IV

fluorouracildrug

Given IV

irinotecan hydrochloridedrug

Given IV

leucovorin calciumdrug

Given IV

oxaliplatindrug

Given IV