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Brief Title: Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas
Official Title: A Phase II Study of Gemcitabine and Docetaxel in Pancreatic Adenocarcinoma
Study ID: NCT00003810
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more that one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and docetaxel in treating patients who have locally advanced or metastatic cancer of the pancreas.
Detailed Description: OBJECTIVES: I. Determine the objective response rate of patients with pancreatic adenocarcinoma treated with combination gemcitabine and docetaxel. II. Determine the toxicity profile of this combination therapy in these patients. III. Assess the survival rate of these patients. OUTLINE: Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes. Patients receive treatment every other week for 8 weeks (4 courses). Patients may continue treatment in the absence of unacceptable toxicity or disease progression. Patients are followed every 12 weeks until death. PROJECTED ACCRUAL: This study will accrue approximately 10 patients per month for a maximum of 33 patients.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Indiana University Cancer Center, Indianapolis, Indiana, United States
Greater Baltimore Medical Center and Cancer Center, Baltimore, Maryland, United States
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
New England Medical Center Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Veterans Affairs Medical Center - Nashville, Nashville, Tennessee, United States
Vanderbilt Cancer Center, Nashville, Tennessee, United States
Veterans Affairs Medical Center - Madison, Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Name: Robert C. Shepard, MD
Affiliation: University of Virginia
Role: STUDY_CHAIR