Bevacizumab, Erlotinib and Capecitabine for Advanced Pancreatic Cancer
The goal of this clinical research study is to find the highest tolerable dose of capecitabine, erlotinib hydrochloride, and bevacizumab that can be given in combination with radiation to patients with pancreatic cancer.
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 Trial of Preoperative Radiotherapy With Concurrent Bevacizumab, Erlotinib and Capecitabine for Locally Advanced Pancreatic Cancer|
- Highest Tolerated Dose of Capecitabine, Erlotinib hydrochloride, and Bevacizumab + Radiation [ Time Frame: 5 1/2 Weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Bevacizumab, Erlotinib + Capecitabine
Bevacizumab IV every 2 weeks at 5 mg/kg, Erlotinib 100 mg PO daily + Capecitabine 400 mg/m2 PO BID only on days of radiation. Radiation treatment once daily for 5 1/2 weeks or 28 doses, Dose 50.4 Gy.
5 mg/kg IV Over 90 Minutes Every 2 Weeks
Other Names:Drug: Erlotinib
100 mg by mouth Once Daily on days with radiation.
Other Names:Drug: Capecitabine
400 mg/m^2 PO Twice Daily on days with radiation.
Other Name: XelodaRadiation: Radiation Therapy
Radiation treatment once daily for 5 1/2 weeks or 28 doses, Dose 50.4 Gy
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00614653
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sunil Krishnan, MD||M.D. Anderson Cancer Center|