Gemcitabine Alone or in Combination With Other Chemotherapy Drugs in Treating Patients With Metastatic Cancer of the Pancreas
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00012220
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective when given alone or in combination with another chemotherapy drug in treating cancer of the pancreas.
PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine given alone or in combination with other chemotherapy drugs in treating patients who have metastatic cancer of the pancreas.
- Detailed Description
OBJECTIVES:
* Compare the overall survival rate of patients with metastatic pancreatic cancer treated with gemcitabine alone vs with cisplatin vs with docetaxel vs with irinotecan.
* Compare the time to disease progression in patients treated with these regimens.
* Compare the CA 19-9 biomarker response in patients treated with these regimens.
* Correlate the CA 19-9 biomarker response with survival in patients treated with these regimens.
* Compare the toxicity of these regimens in these patients.
* Compare the response in patients with measurable disease treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of four treatment arms.
* Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 followed by cisplatin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive gemcitabine IV over 150 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
* Arm III: Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 60 minutes on days 1 and 8. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.
* Arm IV: Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 240 patients (60 per arm) will be accrued for this study within 30 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 259
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gemcitabine + cisplastin gemcitabine hydrochloride Addition of cisplastin to gemcitabine Gemcitabine + docetaxel gemcitabine hydrochloride Addition of docetaxel to gemcitabine Gemcitabine + Irinotecan gemcitabine hydrochloride Addition of irinotecan to gemcitabine Gemcitabine gemcitabine hydrochloride Standard treatment Gemcitabine + Irinotecan irinotecan hydrochloride Addition of irinotecan to gemcitabine Gemcitabine + cisplastin cisplatin Addition of cisplastin to gemcitabine Gemcitabine + docetaxel docetaxel Addition of docetaxel to gemcitabine
- Primary Outcome Measures
Name Time Method Overall Survival 4 years post treatment
- Secondary Outcome Measures
Name Time Method Time to disease progression treatment up to 4 years post treatment Toxicity treatment and up to 4 years post treatment
Trial Locations
- Locations (76)
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Veterans Affairs Medical Center - Asheville
🇺🇸Asheville, North Carolina, United States
Lenoir Memorial Hospital Cancer Center
🇺🇸Kinston, North Carolina, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Louis A. Weiss Memorial Hospital
🇺🇸Chicago, Illinois, United States
West Suburban Center for Cancer Care
🇺🇸River Forest, Illinois, United States
Saint Anthony Medical Center
🇺🇸Rockford, Illinois, United States
Hematology Oncology Associates of the Quad Cities
🇺🇸Bettendorf, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Veterans Affairs Medical Center - Baltimore
🇺🇸Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Veterans Affairs Medical Center - Las Vegas
🇺🇸Las Vegas, Nevada, United States
Elmhurst Hospital Center
🇺🇸Elmhurst, New York, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Queens Cancer Center of Queens Hospital
🇺🇸Jamaica, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
NorthEast Oncology Associates
🇺🇸Concord, North Carolina, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Cape Fear Valley Health System
🇺🇸Fayetteville, North Carolina, United States
FirstHealth Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Lifespan: The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Green Mountain Oncology Group
🇺🇸Bennington, Vermont, United States
Veterans Affairs Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Vermont Cancer Center at University of Vermont
🇺🇸Burlington, Vermont, United States
Virginia Oncology Associates - Norfolk
🇺🇸Norfolk, Virginia, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
🇺🇸Roanoke, Virginia, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Fargo
🇺🇸Fargo, North Dakota, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Veterans Affairs Medical Center - White River Junction
🇺🇸White River Junction, Vermont, United States
Lakeland Medical Center - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Ministry Medical Group - Northern Region
🇺🇸Rhinelander, Wisconsin, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
University of Puerto Rico School of Medicine Medical Sciences Campus
🇵🇷San Juan, Puerto Rico
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
Veterans Affairs Medical Center - San Diego
🇺🇸San Diego, California, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Memorial Regional Hospital Comprehensive Cancer Center
🇺🇸Hollywood, Florida, United States
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
🇺🇸West Palm Beach, Florida, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
🇺🇸Fort Wayne, Indiana, United States
St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Veterans Affairs Medical Center - Washington, DC
🇺🇸Washington, District of Columbia, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Baptist Hospital East - Louisville
🇺🇸Louisville, Kentucky, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Martha Jefferson Hospital
🇺🇸Charlottesville, Virginia, United States