Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

September 20, 2011 updated by: Eastern Cooperative Oncology Group

A Phase III, Randomized Study of Gemcitabine (Fixed-Dose Rate Infusion) and Oxaliplatin (NSC 266046) Versus Gemcitabine (Fixed-Dose Rate Infusion) Versus Gemcitabine (30-Minute Infusion) in Pancreatic Carcinoma

RATIONALE: Drugs used in chemotherapy such as gemcitabine and oxaliplatin use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more tumor cells. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without oxaliplatin in treating patients who have locally advanced or metastatic pancreatic cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare survival of patients with locally advanced or metastatic pancreatic cancer treated with prolonged infusion gemcitabine with vs without oxaliplatin vs standard infusion gemcitabine.
  • Compare the toxicity of these regimens in these patients.
  • Compare the objective response in patients treated with these regimens.
  • Compare the patterns of failure and progression-free survival of patients treated with these regimens.
  • Compare the reported frequency of deep vein thrombosis and pulmonary embolism among patients treated with these regimens.
  • Compare the changes in quality of life, including improved symptom control and/or additional side effects of patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance status (0 or 1 vs 2) and disease stage (locally advanced vs metastatic). Patients are randomized to 1 of 3 treatment arms.

  • Arm I (standard treatment): Patients receive gemcitabine IV over 30 minutes once weekly for 7 weeks followed by 1 week of rest for course 1 only. In all subsequent courses, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15, with courses repeating every 4 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive gemcitabine IV over 150 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm III: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 120 minutes on day 2. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then at 8 and 16 weeks.

Patients are followed for 3 years.

PROJECTED ACCRUAL: A total of 789 patients (263 per treatment arm) will be accrued for this study within 18 months.

Study Type

Interventional

Phase

  • Phase 3

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

  • South Africa
      • Pretoria, South Africa, 0001
        • Pretoria Academic Hospital
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Comprehensive Cancer Institute
    • Arizona
      • Scottsdale, Arizona, United States, 85259-5404
        • CCOP - Mayo Clinic Scottsdale Oncology Program
    • Colorado
      • Aurora, Colorado, United States, 80012-0000
        • Medical Center of Aurora - South Campus
      • Boulder, Colorado, United States, 80301-9019
        • Boulder Community Hospital
      • Colorado Springs, Colorado, United States, 80933
        • Penrose Cancer Center at Penrose Hospital
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, United States, 80218
        • Presbyterian - St. Luke's Medical Center
      • Denver, Colorado, United States, 80224
        • CCOP - Colorado Cancer Research Program, Incorporated
      • Denver, Colorado, United States, 80218-1191
        • St. Joseph Hospital
      • Denver, Colorado, United States, 80220
        • Rocky Mountain Cancer Centers - Denver Rose
      • Englewood, Colorado, United States, 80112
        • Swedish Medical Center
      • Lone Tree, Colorado, United States, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, United States, 80501
        • Hope Cancer Care Center at Longmont United Hospital
      • Pueblo, Colorado, United States, 81004
        • St. Mary-Corwin Regional Medical Center
      • Thornton, Colorado, United States, 80229
        • Rocky Mountain Cancer Centers - Thornton
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University
      • Decatur, Georgia, United States, 30033
        • Veterans Affairs Medical Center - Atlanta (Decatur)
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Chicago, Illinois, United States, 60611-4494
        • Veterans Affairs Medical Center - Lakeside Chicago
      • Decatur, Illinois, United States, 62526
        • CCOP - Central Illinois
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital Cancer Care Institute
      • Hinsdale, Illinois, United States, 60521
        • Hinsdale Hematology Oncology Associates
      • La Grange, Illinois, United States, 60525
        • La Grange Oncology Associates
      • Rockford, Illinois, United States, 61104-2315
        • Swedish-American Regional Cancer Center
      • Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5289
        • Indiana University Cancer Center
      • Indianapolis, Indiana, United States, 46202
        • Veterans Affairs Medical Center - Indianapolis (Roudebush)
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403-1206
        • CCOP - Cedar Rapids Oncology Project
      • Des Moines, Iowa, United States, 50309-1016
        • CCOP - Iowa Oncology Research Association
    • Kansas
      • Wichita, Kansas, United States, 67214-3882
        • CCOP - Wichita
      • Wichita, Kansas, United States, 67218
        • Veterans Affairs Medical Center - Wichita
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • MBCCOP - LSU Health Sciences Center
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02111
        • Cancer Center at Tufts - New England Medical Center
    • Michigan
      • Kalamazoo, Michigan, United States, 49007-3731
        • West Michigan Cancer Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • Veterans Affairs Medical Center - East Orange
      • New Brunswick, New Jersey, United States, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • MBCCOP - University of New Mexico HSC
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein Cancer Center at Albert Einstein College of Medicine
      • New York, New York, United States, 10016
        • NYU Cancer Institute at New York University Medical Center
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • CCOP - Merit Care Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth's Cancer Care Center at MetroHealth Medical Center
      • Columbus, Ohio, United States, 43206
        • CCOP - Columbus
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • CCOP - Oklahoma
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-2001
        • CCOP - Geisinger Clinic and Medical Center
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center at the University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15236
        • Hillman Cancer Center at University of Pittsburgh Cancer Institute
      • Wynnewood, Pennsylvania, United States, 19096
        • CCOP - MainLine Health
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Cancer Center at Lankenau Hospital
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • CCOP - Sioux Community Cancer Consortium
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6307
        • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
    • Texas
      • Temple, Texas, United States, 76508
        • CCOP - Scott and White Hospital
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • CCOP - St. Vincent Hospital Cancer Center, Green Bay
      • Madison, Wisconsin, United States, 53792-0001
        • University of Wisconsin Comprehensive Cancer Center
      • Marshfield, Wisconsin, United States, 54449
        • CCOP - Marshfield Clinic Research Foundation

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma or poorly differentiated carcinoma
  • Ineligible for curative resection
  • Measurable and/or nonmeasurable disease
  • Must have evidence of disease outside prior radiation fields OR radiologically confirmed progression of disease within the radiation fields after completion of radiotherapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 3,500/mm^3 OR
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 125,000/mm^3

Hepatic

  • Bilirubin < 2.0 mg/dL
  • AST < 3 times upper limit of normal (ULN)

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No uncontrolled cardiac disease

Other

  • Not pregnant or nursing

  • Negative pregnancy test

    • Negative vaginal ultrasound for patients with an elevated beta human chorionic gonadotropin level
  • Fertile patients must use effective nonhormonal contraception
  • No other malignancies within the past 5 years except nonmetastatic, nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer cured by surgery or small field radiotherapy
  • No active or uncontrolled infection
  • No other active illness that would preclude study participation
  • No symptomatic sensory peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for metastatic disease
  • No prior (including adjuvant) gemcitabine or oxaliplatin
  • Prior adjuvant chemotherapy allowed provided there was more than 6 months between the last dose of adjuvant chemotherapy and recurrence of pancreatic cancer
  • Prior chemotherapy as a radiosensitizing agent allowed* NOTE: *To the primary site

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy to the primary tumor site and recovered
  • No prior radiotherapy to more than 25% of the functional bone marrow

Surgery

  • See Disease Characteristics
  • Prior surgical resection allowed

Other

  • No concurrent participation in supportive care trials
  • Concurrent enrollment on protocol ECOG-E1Y03 allowed

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
  • Allocation: Randomized

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: Elizabeth A. Poplin, MD, Rutgers Cancer Institute of New Jersey

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

March 1, 2003

Primary Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

April 7, 2003

First Submitted That Met QC Criteria

April 8, 2003

First Posted (Estimate)

April 9, 2003

Study Record Updates

Last Update Posted (Estimate)

September 21, 2011

Last Update Submitted That Met QC Criteria

September 20, 2011

Last Verified

April 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000287015
  • ECOG-6201

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.

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