Bevacizumab, Erlotinib, and Capecitabine for Locally Advanced Rectal Cancer
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.
Radiation: Radiation Therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Trial of Preoperative Radiotherapy With Concurrent Bevacizumab, Erlotinib and Capecitabine for Locally Advanced Rectal Cancer|
- Maximal tolerated dose (MTD) [ Time Frame: Continuoual Reassessment Weeks 1- 6 ] [ Designated as safety issue: Yes ]MTD derived from differing dose combinations of Capecitabine, Bevacizumab, and Erlotinib of using the continual reassessment method (CRM). Dose limiting toxicity defined as any grade 3 or higher acute toxicity during chemoradiation. The MTD will be defined as the dose at which grade 3 or higher acute toxicity exceeds 25%.
|Study Start Date:||December 2007|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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.
5 mg/kg By Vein Every 2 Weeks x 3 Doses (Weeks 1, 3, 5)
Other Names:Drug: Capecitabine
Starting Dose 650 mg/m^2 By Mouth Twice Daily Monday-Friday x 6 Weeks
Other Name: XelodaDrug: Erlotinib
Starting Dose 50 mg By Mouth Daily Weeks 1-3
Other Names: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
Other Names:Procedure: Surgery
At least 8 weeks after radiation therapy, surgical removal of rectal tumor
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00543842
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Prajnan Das, MD||UT MD Anderson Cancer Center|