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

June 13, 2023 updated by: Eastern Cooperative Oncology Group

A Phase II Study of Gemcitabine and Docetaxel in Pancreatic Adenocarcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5265
        • Indiana University Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center and Cancer Center
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Oncology Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02111
        • New England Medical Center Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • CCOP - Missouri Valley Cancer Consortium
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt Cancer Center
      • Nashville, Tennessee, United States, 37212
        • Veterans Affairs Medical Center - Nashville
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Veterans Affairs Medical Center - Madison
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Robert C. Shepard, MD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 1999

Primary Completion (Actual)

May 1, 2002

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

August 3, 2004

First Posted (Estimated)

August 4, 2004

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066955
  • ECOG-1298

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

Clinical Trials on docetaxel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe