Clinical trialPhase 2Completed
Efficacy of Neoadjuvant Chemoradiation for Potentially Resectable Pancreas Cancer
Phase II Study of the Anti-Vascular Endothelial Growth Factor (α-VEGF) Monoclonal Antibody Bevacizumab in Combination With Fixed Dose Rate (FDR) Gemcitabine and Rapid-Fractionation Radiotherapy in the Pre-operative Treatment of Potentially- Resectable Pancreatic Adenocarcinoma
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- December 2006
- Expected end
- December 2016
- Enrollment
- 59 participants
- Sites
- 1
- Primary outcomes
- Rate of Margin Negative Surgical Resection (R0 Resection Rate); Rate of Pathologic Complete Response (pCR)
- Sponsor
- Other
- Results posted
- 2016-12-12
- Last update
- 25 September 2018
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Rate of Margin Negative Surgical Resection (R0 Resection Rate) [Up to 48 months]. Number, percentage of participants (95% Confidence Interval). FDR GEM + BEV +/- BEV/RT (n=43): 88 (75 to 96).
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Rate of Pathologic Complete Response (pCR) [Up to 48 months]. Number, percentage of participants (95% Confidence Interval). FDR GEM + BEV +/- BEV/RT (n=43): 2.3 (0.1 to 12).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [Up to 48 months]. Number, months (95% Confidence Interval). FDR GEM + BEV +/- BEV/RT (n=58): 16.8 (14.9 to 21.3).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [Up to 48 months]. Number, months (95% Confidence Interval). FDR GEM + BEV +/- BEV/RT (n=43): 19.7 (16.5 to 28.2).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival (PFS) [Up to 48 months]. Median, months (95% Confidence Interval). FDR GEM + BEV +/- BEV/RT (n=58): 6.6 (4.9 to 12.4).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival (PFS) [Up to 48 months]. Median, months (95% Confidence Interval). FDR GEM + BEV +/- BEV/RT (n=43): 12.9 (7.0 to 18.7).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Rate of Surgical Resection [Up to 48 months]. Number, percentage of participants. FDR GEM + BEV +/- BEV/RT (n=58): 74.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Radiographic Tumor Response [Up to 48 months]. Number, Participants. metastatic progression (at restaging): FDR GEM + BEV +/- BEV/RT (n=58): 4. stable disease: FDR GEM + BEV +/- BEV/RT (n=58): 39. partial response: FDR GEM + BEV +/- BEV/RT (n=58): 5. progressive disease: FDR GEM + BEV +/- BEV/RT (n=58): 10.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Ca 19-9 Level (in Serum) - Biomarker Response [Baseline and up to 48 months]. Mean, percentage decrease in serum Ca19-9 leve (Standard Deviation). FDR GEM + BEV +/- BEV/RT (n=54): 25 (80).