Neoplasms

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Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

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Pancreatic Cancer

All Drugs and Chemicals

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Antibodies

Antibodies, Monoclonal

Gemcitabine

Bevacizumab

Immunoglobulins

Endothelial Growth Factors

Mitogens

Pancrelipase

Pancreatin

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Intervention: Drug: Avastin (bevacizumab) 10 mg/kg, days 1, 15, 29 and 43

Intervention: Drug: Gemzar (Gemcitabine) 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).

Intervention:Radiation: external beam radiotherapy 3 Gy/fraction utilizing a 95% isodose field over 10 consecutive weekdays, Monday to Friday, for a total of 30 Gy

Avastin (bevacizumab)

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).

Gemzar (Gemcitabine)

3 Gy/fraction utilizing a 95% isodose field over 10 consecutive weekdays, Monday to Friday, for a total of 30 Gy

external beam radiotherapy

Herbert J. Zeh, MD

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.

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

Number of participants who underwent laparoscopy and pancreatic resections that were margin negative/total number of participants who underwent laparoscopy and pancreatic resections.

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.

Number of participants that underwent resection / per the total number of evaluable participants

CT scans evaluated for response using Response Evaluation Criteria in Solid Tumors (RECIST)

Percentage decrease in Ca 19-9 level (in serum)

Amer Zureikat

Assistant Professor

Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m\^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1-2 cm vascular margin, +/- laparoscopy and resection after day 85.

FDR GEM + BEV +/- BEV/RT

Age, Continuous

Sex: Female, Male

Herbert Zeh, MD

Participants who underwent laparoscopy and pancreatic resection.

Rate of Margin Negative Surgical Resection (R0 Resection Rate)

Participants who underwent laparoscopy and pancreatic resections.

Rate of Pathologic Complete Response (pCR)

Overall Survival (OS)

Includes participants who underwent laparoscopy and pancreatic resection.

Progression-free Survival (PFS)

Rate of Surgical Resection

metastatic progression (at restaging)

stable disease

partial response

progressive disease

Radiographic Tumor Response

Participants that did NOT demonstrate metastatic progression upon restaging CT.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy of Neoadjuvant Chemoradiation for Potentially Resectable Pancreas Cancer	NCT00557492	Pancreatic Canc...	Avastin (bevaci... Gemzar (Gemcita... external beam r...	18 Years - 80 Years	University of Pittsburgh
Efficacy of Neoadjuvant Chemoradiation for Potentially Resectable Pancreas Cancer	NCT00557492	Pancreatic Canc...	Avastin (bevaci... Gemzar (Gemcita... external beam r...	18 Years - 80 Years	University of Pittsburgh

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