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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Genentech |
| Information provided by (Responsible Party): | 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 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bevacizumab, Erlotinib + Capecitabine
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
Other Names:
Drug: Erlotinib
100 mg by mouth Once Daily on days with radiation.
Other Names:
Drug: Capecitabine
400 mg/m^2 PO Twice Daily on days with radiation.
Other Name: Xeloda
Radiation: Radiation Therapy
Radiation treatment once daily for 5 1/2 weeks or 28 doses, Dose 50.4 Gy
Other Names:
|
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 | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Sunil Krishnan, MD | |
| Principal Investigator: | Sunil Krishnan, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00614653 History of Changes |
| Other Study ID Numbers: | 2007-0044 |
| Study First Received: | January 31, 2008 |
| Last Updated: | May 14, 2012 |
| 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 |
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Antibodies Antibodies, Monoclonal Fluorouracil Capecitabine Bevacizumab Erlotinib Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors |