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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Genentech |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00047710 |
Purpose
The goal of this clinical research study is to find the highest safe dose of the drug Bevacizumab that can be given in combination with chemoradiation for the treatment of pancreatic cancer. The effect that this combination treatment has on the tumor will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: Bevacizumab Drug: Capecitabine Radiation: Radiotherapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
| Official Title: | A Phase I Trial of Concurrent RHUMAB VEGF (BEVACIZUMAB) and Capecitabine-Based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer |
| Enrollment: | 48 |
| Study Start Date: | September 2002 |
| Study Completion Date: | July 2006 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Bevacizumab: Experimental
Radiation, Bevacizumab, and Capecitabine
|
Drug: Bevacizumab
Beginning 2 weeks prior to radiotherapy, dose of 5 mg/kg by vein then of 2.5 mg/kg during radiotherapy for four weeks every 2 weeks (three doses).
Drug: Capecitabine
650mg/m^2 taken by mouth twice a day 15-52 during the radiotherapy.
Radiation: Radiotherapy
Radiography given once a day for 5 days at 50.4 Gy in 28 fractions over 5.5 weeks.
|
This study administers 50.4 Gy of radiation for unresectable pancreatic cancer with concurrent capecitabine and an experimental drug, Bevacizumab. The drug is an antiangiogenic agent (kills tumor blood vessels) and has been shown in preclinical models to enhance the antitumor effect of radiation and chemotherapy.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| University of Texas MDAnderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Christopher H. Crane, MD | U.T. M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T. M.D. Anderson Cancer Center ( Christopher H. Crane, MD / Associate Professor ) |
| Study ID Numbers: | ID02-146 |
| Study First Received: | October 14, 2002 |
| Last Updated: | July 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00047710 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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pancreatic cancer pancreas cancer pancreas |
|
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Pancreatic Neoplasms Physiological Effects of Drugs Endocrine System Diseases Bevacizumab |
Angiogenesis Inhibitors Pharmacologic Actions Antibodies, Monoclonal Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Pancreatic Diseases Growth Inhibitors Angiogenesis Modulating Agents Endocrine Gland Neoplasms |