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Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00003810
Recruitment Status : Completed
First Posted : August 4, 2004
Last Update Posted : August 23, 2013
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: docetaxel Drug: gemcitabine hydrochloride Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma or poorly differentiated carcinoma of the pancreas Metastatic disease with at least 1 bidimensionally measurable lesion OR Locally advanced disease that is either recurrent or not amenable to surgery Measurable disease outside of prior radiation port or disease progression within the port

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 125,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT no greater than 2.5 times ULN (less than 3 times ULN if liver metastases) Renal: Creatinine no greater than ULN Other: Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease At least 1 year since prior adjuvant chemotherapy Prior chemoradiotherapy as initial therapy allowed Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics See Chemotherapy At least 4 weeks since prior radiotherapy Surgery: Not specified

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Robert C. Shepard, MD University of Virginia
More Information

ClinicalTrials.gov Identifier: NCT00003810     History of Changes
Other Study ID Numbers: CDR0000066955
First Posted: August 4, 2004    Key Record Dates
Last Update Posted: August 23, 2013
Last Verified: August 2013

Keywords provided by Eastern Cooperative Oncology Group:
stage III pancreatic cancer
stage IV pancreatic cancer
recurrent pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators