CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
5-fluorouracil +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/NCT00307736
NCT00307736Phase 2Completed
CompareCT.gov

A Phase I/II Study of Bevacizumab, Erlotinib and 5-fluorouracil With Concurrent External Beam Radiation Therapy in Locally Advanced Rectal Cancer

Massachusetts General Hospital·interventional·Posted Mar 28, 2006·Updated May 10, 2017

In Brief

A Phase 2 clinical trial evaluating 5-fluorouracil, bevacizumab, and 2 other interventions for Rectal Cancer and Adenocarcinoma of the Rectum. Completed, enrolled 32 participants across 3 sites.

Detailed Summary

The purpose of this study is determine the safety of 5-fluorouracil, bevacizumab and erlotinib when administered in combination with external beam radiation therapy(Phase I portion) as well as to begin to collect information about whether this combination treatment is effective in treating(Phase II portion) patients with locally advanced rectal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRectal Cancer, Adenocarcinoma of the Rectum
CountriesUnited States
CollaboratorsBeth Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Genentech, Inc.

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 28, 2006
Enrollment StartMay 1, 2006
Primary CompletionApr 1, 2010
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 20.3 years ago

Interventions

5-fluorouracildrug

Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.

bevacizumabdrug

Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.

erlotinibdrug

Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.

External beam radiation therapy (EBRT)procedure

Given on days 1-5 and 8-12