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Bevacizumab, Erlotinib, and Capecitabine for Locally Advanced Rectal Cancer

NCT00543842 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2015-02-26

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerable dose of bevacizumab (Avastin) and erlotinib hydrochloride (Tarceva) that can be given in combination with standard radiation therapy and capecitabine before surgery to patients with rectal cancer. The safety and effectiveness of this combination of therapies will also be studied.

The goal of this Phase I trial was to determine the maximal tolerated dose (MTD) of concurrent capecitabine, bevacizumab and erlotinib with preoperative radiation therapy (RT) for rectal cancer. The trial completed as Phase I without progressing to the Phase II portion.

Conditions

Interventions

DRUG

Bevacizumab

5 mg/kg By Vein Every 2 Weeks x 3 Doses (Weeks 1, 3, 5)

DRUG

Capecitabine

Starting Dose 650 mg/m\^2 By Mouth Twice Daily Monday-Friday x 6 Weeks

DRUG

Erlotinib

Starting Dose 50 mg By Mouth Daily Weeks 1-3

RADIATION

Radiation Therapy

30 minute radiation treatments, dose of 50.4 Gy once daily on 5 consecutive days, for up to 5 weeks and 3 days, totaling 28 treatments

PROCEDURE

Surgery

At least 8 weeks after radiation therapy, surgical removal of rectal tumor

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Prajnan Das, MD · UT MD Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00543842 on ClinicalTrials.gov