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Sponsors and Collaborators: |
Fox Chase Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00066677 |
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with docetaxel may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying bevacizumab and docetaxel to see how well they work compared to bevacizumab alone in treating patients with metastatic pancreatic cancer.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Biological: bevacizumab Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | Phase II and Coagulation Study of rhuMAb-VEGF With or Without Docetaxel in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma |
Estimated Enrollment: | 46 |
Study Start Date: | October 2003 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 46 patients (23 per treatment arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the pancreas
Unidimensionally measurable disease outside of the pancreas
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Pennsylvania | |
Fox Chase Cancer Center - Philadelphia | |
Philadelphia, Pennsylvania, United States, 19111-2497 |
Study Chair: | Steven J. Cohen, MD | Fox Chase Cancer Center |
Study ID Numbers: | CDR0000316454, FCCC-03003 |
Study First Received: | August 6, 2003 |
Last Updated: | August 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00066677 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the pancreas recurrent pancreatic cancer stage IV pancreatic cancer |
Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Bevacizumab Angiogenesis Inhibitors Pancrelipase Recurrence |
Docetaxel Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Endocrine Gland Neoplasms |
Digestive System Neoplasms Antineoplastic Agents Growth Substances Pancreatic Neoplasms Physiological Effects of Drugs Endocrine System Diseases Bevacizumab Angiogenesis Inhibitors Pharmacologic Actions |
Docetaxel Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Pancreatic Diseases Growth Inhibitors Angiogenesis Modulating Agents Endocrine Gland Neoplasms |