Study of Combined RHUMAB VEGF and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer
The goal of this clinical research study is to find the highest safe dose of the drug Bevacizumab that can be given in combination with chemoradiation for the treatment of pancreatic cancer. The effect that this combination treatment has on the tumor will also be studied.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of Concurrent RHUMAB VEGF (BEVACIZUMAB) and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer|
- Safety of combination Radiation, Bevacizumab, and Capecitabine. [ Time Frame: 6 weeks after the completion of therapy ] [ Designated as safety issue: Yes ]
- To evaluate the local tumor response and median survival in patients treated with the above regimen. [ Time Frame: 6 weeks after the completion of therapy. ] [ Designated as safety issue: No ]
- To evaluate VEGF serum levels before and after anti-VEGF therapy. [ Time Frame: 6 weeks after the completion of therapy. ] [ Designated as safety issue: No ]
- To evaluate tumor hypoxia via PET scanning (gallium PET with the novel hypoxia tracer Ga-68 ECMN) before, during, and after therapy. [ Time Frame: 6 weeks after the completion of therapy. ] [ Designated as safety issue: No ]
- To evaluate quality of life in patients receiving this therapy. [ Time Frame: 6 weeks after the completion of therapy. ] [ Designated as safety issue: No ]
|Study Start Date:||September 2002|
|Study Completion Date:||July 2006|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
Radiation, Bevacizumab, and Capecitabine
Beginning 2 weeks prior to radiotherapy, dose of 5 mg/kg by vein then of 2.5 mg/kg during radiotherapy for four weeks every 2 weeks (three doses).
Other Names:Drug: Capecitabine
650mg/m^2 taken by mouth twice a day 15-52 during the radiotherapy.
Other Name: XelodaRadiation: Radiotherapy
Radiography given once a day for 5 days at 50.4 Gy in 28 fractions over 5.5 weeks.
Other Name: XRT
This study administers 50.4 Gy of radiation for unresectable pancreatic cancer with concurrent capecitabine and an experimental drug, Bevacizumab. The drug is an antiangiogenic agent (kills tumor blood vessels) and has been shown in preclinical models to enhance the antitumor effect of radiation and chemotherapy.
|United States, Texas|
|University of Texas MDAnderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Christopher H. Crane, MD||M.D. Anderson Cancer Center|