Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
University of Pittsburgh |
---|---|
Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00557492 |
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.
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer |
Drug: Avastin (bevacizumab) Drug: Gemzar (Gemcitabine) Radiation: external beam radiotherapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | 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 |
Estimated Enrollment: | 60 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Symptomatic or endoscopic evidence of gastric outlet obstruction
• Endoscopic findings suggesting tumor erosion into the gastrointestinal mucosa.
Contact: Arthur J. Moser, MD | 412-647-0132 | moseraj@upmc.edu |
Contact: Connie H. Kinney, RN, BSN | 412-623-3471 | kinneych@upmc.edu |
United States, Pennsylvania | |
University of Pittsburgh Medical Centers | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Sub-Investigator: Herbert J Zeh, MD | |
Sub-Investigator: Kenneth Lee, MD | |
Sub-Investigator: David L Bartlett, MD | |
Sub-Investigator: Steven Ahrendt, MD | |
Sub-Investigator: Linda M Farkas, MD | |
Sub-Investigator: Barry Lembersky, MD |
Principal Investigator: | Arthur J. Moser, MD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh ( A. James Moser, MD ) |
Study ID Numbers: | 06-035 |
Study First Received: | November 13, 2007 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00557492 |
Health Authority: | United States: Institutional Review Board |
pancreas pancreatic cancer resectable |
Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Bevacizumab Endothelial Growth Factors Pancrelipase Antibodies, Monoclonal Antibodies |
Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Gemcitabine Immunoglobulins Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |