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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Genentech |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00614653 |
Purpose
The goal of this clinical research study is to find the highest tolerable dose of capecitabine, erlotinib hydrochloride, and bevacizumab that can be given in combination with radiation to patients with pancreatic cancer.
| 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 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Bevacizumab, Erlotinib + Capecitabine: Experimental
Bevacizumab IV every 2 weeks at 5 mg/kg, Erlotinib 100 mg PO daily + Capecitabine 400 mg/m2 PO BID only on days of radiation.
|
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
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| 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: | December 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00614653 History of Changes |
| 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 |
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Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Bevacizumab Protein Kinase Inhibitors Antibodies, Monoclonal Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents |
Growth Inhibitors Endocrine Gland Neoplasms Erlotinib Capecitabine Digestive System Neoplasms Growth Substances Endocrine System Diseases Enzyme Inhibitors Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Digestive System Diseases Pancreatic Diseases |