Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas
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.
|Pancreatic Cancer||Drug: docetaxel Drug: gemcitabine hydrochloride||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of Gemcitabine and Docetaxel in Pancreatic Adenocarcinoma|
|Study Start Date:||April 1999|
|Primary Completion Date:||May 2002 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003810
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-5265|
|United States, Maryland|
|Greater Baltimore Medical Center and Cancer Center|
|Baltimore, Maryland, United States, 21204|
|Johns Hopkins Oncology Center|
|Baltimore, Maryland, United States, 21287|
|United States, Massachusetts|
|New England Medical Center Hospital|
|Boston, Massachusetts, United States, 02111|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Nebraska|
|CCOP - Missouri Valley Cancer Consortium|
|Omaha, Nebraska, United States, 68131|
|United States, Tennessee|
|Veterans Affairs Medical Center - Nashville|
|Nashville, Tennessee, United States, 37212|
|Vanderbilt Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|United States, Wisconsin|
|Veterans Affairs Medical Center - Madison|
|Madison, Wisconsin, United States, 53705|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Study Chair:||Robert C. Shepard, MD||University of Virginia|