Study of Combined RHUMAB VEGF and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00047710|
Recruitment Status : Completed
First Posted : October 16, 2002
Last Update Posted : August 1, 2012
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Bevacizumab Drug: Capecitabine Radiation: Radiotherapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Concurrent RHUMAB VEGF (BEVACIZUMAB) and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||July 2006|
|Actual Study Completion Date :||July 2006|
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).
650mg/m^2 taken by mouth twice a day 15-52 during the radiotherapy.
Other Name: Xeloda
Radiography given once a day for 5 days at 50.4 Gy in 28 fractions over 5.5 weeks.
Other Name: XRT
- Safety of combination Radiation, Bevacizumab, and Capecitabine. [ Time Frame: 6 weeks after the completion of therapy ]
- 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. ]
- To evaluate VEGF serum levels before and after anti-VEGF therapy. [ Time Frame: 6 weeks after the completion of therapy. ]
- 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. ]
- To evaluate quality of life in patients receiving this therapy. [ Time Frame: 6 weeks after the completion of therapy. ]
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): NCT00047710
|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|