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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
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.
Radiography given once a day for 5 days at 50.4 Gy in 28 fractions over 5.5 weeks.
University of Texas MDAnderson Cancer Center
Houston, Texas, United States
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.
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