Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT00058149
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (61)
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Hope Cancer Care Center at Longmont United Hospital
🇺🇸Longmont, Colorado, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Veterans Affairs Medical Center - East Orange
🇺🇸East Orange, New Jersey, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation
🇺🇸Marshfield, Wisconsin, United States
Veterans Affairs Medical Center - Lakeside Chicago
🇺🇸Chicago, Illinois, United States
Cancer Center at Tufts - New England Medical Center
🇺🇸Boston, Massachusetts, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
St. Mary-Corwin Regional Medical Center
🇺🇸Pueblo, Colorado, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
🇺🇸Decatur, Georgia, United States
Comprehensive Cancer Institute
🇺🇸Huntsville, Alabama, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Boulder Community Hospital
🇺🇸Boulder, Colorado, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Sky Ridge Medical Center
🇺🇸Lone Tree, Colorado, United States
Pretoria Academic Hospital
🇿🇦Pretoria, South Africa
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
La Grange Oncology Associates
🇺🇸La Grange, Illinois, United States
Abramson Cancer Center at the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Oklahoma
🇺🇸Tulsa, Oklahoma, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
🇺🇸Indianapolis, Indiana, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
🇺🇸Nashville, Tennessee, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
Penrose Cancer Center at Penrose Hospital
🇺🇸Colorado Springs, Colorado, United States
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
Rocky Mountain Cancer Centers - Thornton
🇺🇸Thornton, Colorado, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
St. Joseph Hospital
🇺🇸Denver, Colorado, United States
Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center
🇺🇸Denver, Colorado, United States
Rocky Mountain Cancer Centers - Denver Rose
🇺🇸Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated
🇺🇸Denver, Colorado, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Hinsdale Hematology Oncology Associates
🇺🇸Hinsdale, Illinois, United States
Medical Center of Aurora - South Campus
🇺🇸Aurora, Colorado, United States
Swedish-American Regional Cancer Center
🇺🇸Rockford, Illinois, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
NYU Cancer Institute at New York University Medical Center
🇺🇸New York, New York, United States
Lankenau Cancer Center at Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
CCOP - Geisinger Clinic and Medical Center
🇺🇸Danville, Pennsylvania, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
MBCCOP - University of New Mexico HSC
🇺🇸Albuquerque, New Mexico, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States