CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
FOLFOX +1 moredrug
Likely dose
FOLFOX 400 mg/m2from 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/NCT00673673
NCT00673673Phase 2Completed
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Phase II Study of FOLFOX With Bevacizumab (Avastin(TM)) in Metastatic or Unresectable Gastroesophageal and Gastric Cancer

Yale University·interventional·Posted May 7, 2008·Updated Feb 4, 2015

In Brief

A Phase 2 clinical trial evaluating FOLFOX and bevacizumab for Gastroesophageal Cancer and Gastric Cancer. Completed, enrolled 39 participants across 2 sites.

Detailed Summary

This is a Phase II open-label study to determine the anti-tumor efficacy and tolerability of FOLFOX in combination with bevacizumab (Avastin(TM))in patients with metastatic or unresectable gastroesophageal and gastric adenocarcinoma. Our primary objective is to determine the time to progression in patients treated with FOLFOX in combination with bevacizumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Cancer, Gastric Cancer
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 7, 2008
Enrollment StartMay 1, 2008
Primary CompletionMay 1, 2013
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 18.2 years ago

Interventions

FOLFOXdrug

Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours

bevacizumabdrug

bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy