Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
M.D. Anderson Cancer Center Genentech |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00614653 |
Primary Objective:
1. To evaluate the safety of adding bevacizumab and erlotinib to capecitabine-based chemoradiation in patients with locally advanced pancreatic cancer.
Secondary Objectives:
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer |
Drug: Bevacizumab Drug: Erlotinib Drug: Capecitabine Radiation: Radiation Therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Trial of Preoperative Radiotherapy With Concurrent Bevacizumab, Erlotinib and Capecitabine for Locally Advanced Pancreatic Cancer |
Estimated Enrollment: | 30 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Bevacizumab + Erlotinib + Capecitabine
|
Drug: Bevacizumab
5 mg/kg IV Over 90 Minutes Every 2 Weeks
Drug: Erlotinib
100 mg PO Twice Daily on days with radiation.
Drug: Capecitabine
400 mg/m^2 PO Twice Daily on days with radiation.
Radiation: Radiation Therapy
Radiation treatment once daily for 5 1/2 weeks or 28 doses, Dose 50.4 Gy
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sunil Krishnan, MD | 713-563-2361 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Sunil Krishnan, MD |
Principal Investigator: | Sunil Krishnan, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Sunil Krishnan, MD/Assistant Professor ) |
Study ID Numbers: | 2007-0044 |
Study First Received: | January 31, 2008 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00614653 |
Health Authority: | United States: Institutional Review Board |
Pancreatic Cancer Bevacizumab Avastin™ Anti-VEGF monoclonal antibody rhuMAb-VEGF Erlotinib |
Erlotinib Hydrochloride Tarceva OSI-774 Capecitabine Xeloda |
Erlotinib Capecitabine Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Bevacizumab Antibodies, Monoclonal |
Antibodies Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Immunoglobulins Endocrine Gland Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Protein Kinase Inhibitors Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |