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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: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: Bevacizumab
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).
Other Names:
Drug: Capecitabine
650mg/m^2 taken by mouth twice a day 15-52 during the radiotherapy.
Other Name: Xeloda
Radiation: Radiotherapy
Radiography given once a day for 5 days at 50.4 Gy in 28 fractions over 5.5 weeks.
Other Name: XRT
|
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 | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Christopher H. Crane, MD / Associate Professor, U.T. M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00047710 History of Changes |
| Other Study ID Numbers: | ID02-146 |
| Study First Received: | October 14, 2002 |
| Last Updated: | July 6, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
pancreatic cancer pancreas cancer pancreas |
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Antibodies, Monoclonal Fluorouracil Capecitabine Bevacizumab 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 |