Bevacizumab, Erlotinib, and Capecitabine for Locally Advanced Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT00543842|
Recruitment Status : Completed
First Posted : October 15, 2007
Last Update Posted : February 26, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Drug: Bevacizumab Drug: Capecitabine Drug: Erlotinib Radiation: Radiation Therapy Procedure: Surgery||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Trial of Preoperative Radiotherapy With Concurrent Bevacizumab, Erlotinib and Capecitabine for Locally Advanced Rectal Cancer|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
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)
Starting Dose 650 mg/m^2 By Mouth Twice Daily Monday-Friday x 6 Weeks
Other Name: Xeloda
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
At least 8 weeks after radiation therapy, surgical removal of rectal tumor
- Maximal tolerated dose (MTD) [ Time Frame: Continuoual Reassessment Weeks 1- 6 ]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%.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00543842
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Prajnan Das, MD||UT MD Anderson Cancer Center|