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Bevacizumab, Erlotinib and 5-Fluorouracil With External Beam Radiation Therapy in Locally Advanced Rectal Cancer

NCT00307736 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-05-10

Study results available
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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.

Conditions

Interventions

DRUG

5-fluorouracil

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

DRUG

bevacizumab

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

DRUG

erlotinib

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

PROCEDURE

External beam radiation therapy (EBRT)

Given on days 1-5 and 8-12

Sponsors & Collaborators

Principal Investigators

  • Lawrence S. Blaszkowsky, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2010-04-30
Completion
2011-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00307736 on ClinicalTrials.gov