Bevacizumab, Erlotinib, and Capecitabine for Locally Advanced Rectal Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00543842
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    5 mg/kg By Vein Every 2 Weeks x 3 Doses (Weeks 1, 3, 5)
  • Capecitabine — DRUG
    Starting Dose 650 mg/m\^2 By Mouth Twice Daily Monday-Friday x 6 Weeks
  • Erlotinib — DRUG
    Starting Dose 50 mg By Mouth Daily Weeks 1-3
  • Radiation Therapy — RADIATION
    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
  • Surgery — PROCEDURE
    At least 8 weeks after radiation therapy, surgical removal of rectal tumor

Study Details

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.

Key Dates

First listed
Oct 15, 2007
Start date
Dec 31, 2007
Status verified
Feb 2015
Primary completion
Dec 31, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab + Erlotinib + Capecitabine + Radiation Therapy
    Bevacizumab 5 mg/kg intravenous (IV) every 2 weeks for 3 Doses (Weeks 1, 3, 5). Erlotinib starting dose 50 mg orally daily Weeks 1-3. Capecitabine starting dose 650 mg/m\^2 orally twice daily Monday-Friday for 6 Weeks. 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. At least 8 weeks after radiation therapy, surgical removal of rectal tumor.

Primary Outcome Measure

Maximal tolerated dose (MTD) [ Time Frame: Continuoual Reassessment Weeks 1- 6 ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

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By specialty
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