This study is to determine the efficacy of bevacizumab and gemcitabine in combination with radiation therapy in the preoperative treatment of potentially-resectable subjects with pancreatic cancer.
This is a 2 stage phase II study of bevacizumab (10 mg/kg) and fixed dose rate (FDR) gemcitabine (1500 mg/m2 at 10 mg/kg/min) in combination with sequential rapid fractionation radiotherapy (30 Gy total) in the preoperative treatment of potentially-resectable subjects with adenocarcinoma of the pancreas. The purpose of this study is to determine the rate of margin negative surgical resection (R0 resection rate) and the rate of complete pathological response in patients with resected pancreas cancer. The overall goal of this study is to determine the merit of this novel regimen for further study in a Phase III trial examining time to progression and overall survival. Based on the need for 48 evaluable subjects to evaluate the primary endpoints, the study will be opened with a target accrual of 60 subjects given an expected 20% rate of attrition observed in prior studies of subjects with pancreas cancer at UPCI.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
10 mg/kg, days 1, 15, 29 and 43
On days 1, 15, and 29, subjects will receive gemcitabine 1500 mg/m2 IV over 150 minutes at the fixed-dose rate (10 mg/m2/min).
3 Gy/fraction utilizing a 95% isodose field over 10 consecutive weekdays, Monday to Friday, for a total of 30 Gy
University of Pittsburgh Medical Centers
Pittsburgh, Pennsylvania, United States
Rate of Margin Negative Surgical Resection (R0 Resection Rate)
Number of participants who underwent laparoscopy and pancreatic resections that were margin negative/total number of participants who underwent laparoscopy and pancreatic resections.
Time frame: Up to 48 months
Rate of Pathologic Complete Response (pCR)
Rate of pathologic complete response (pCR) is no residual invasive tumor, in situ carcinoma can be present, and no residual lymph node metastasis. Rate of pCR is the number of participants who underwent laparoscopy and pancreatic resections that experienced complete pathologic response/total number of participants who underwent laparoscopy and pancreatic resections.
Time frame: Up to 48 months
Overall Survival (OS)
Time frame: Up to 48 months
Progression-free Survival (PFS)
Time frame: Up to 48 months
Rate of Surgical Resection
Number of participants that underwent resection / per the total number of evaluable participants
Time frame: Up to 48 months
Radiographic Tumor Response
CT scans evaluated for response using Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Up to 48 months
Ca 19-9 Level (in Serum) - Biomarker Response
Percentage decrease in Ca 19-9 level (in serum)
Time frame: Baseline and up to 48 months
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