Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT00023972
- Lead Sponsor
- Daiichi Sankyo
- 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 with or without exatecan mesylate in treating pancreatic cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine alone to that of gemcitabine and exatecan mesylate in treating patients who have locally advanced or metastatic pancreatic cancer.
- Detailed Description
OBJECTIVES:
* Compare the overall survival of patients with chemotherapy-naive locally advanced or metastatic cancer of the exocrine pancreas treated with exatecan mesylate and gemcitabine versus gemcitabine alone.
* Compare the measures of clinical benefit in patients treated with these regimens.
* Compare the anti-tumor efficacy of these regimens in this patient population.
* Determine the safety profile of exatecan mesylate and gemcitabine in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to performance status (60% vs 70-80% vs 90-100%), extent of disease (locally advanced vs metastatic), and prior radiotherapy for pancreatic cancer (yes or no). Patients are randomized to one of two treatment arms.
* Arm I: Patients receive exatecan mesylate (DX-8951f) IV over 30 minutes immediately followed by gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive gemcitabine IV over 30 minutes once weekly for up to 7 weeks followed by one week of rest (course 1). For all subsequent courses, patients receive gemcitabine once weekly for 3 weeks followed by one week of rest. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly.
PROJECTED ACCRUAL: Approximately 340 patients (170 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 (74)
Summit Medical Group, P.A.
🇺🇸Summit, New Jersey, United States
HemOnCare, P.C.
🇺🇸Brooklyn, New York, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Family Cancer Center
🇺🇸Germantown, Tennessee, United States
MD Anderson Cancer Center Orlando
🇺🇸Orlando, Florida, United States
Billings Oncology Associates
🇺🇸Billings, Montana, United States
Memorial Hospital Cancer Center - Chattanooga
🇺🇸Chattanooga, Tennessee, United States
Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
Hope Center
🇺🇸Terre Haute, Indiana, United States
N.W. Carolina Oncology & Hematology, P.A.
🇺🇸Hickory, North Carolina, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Medical Oncology and Hematology, P.C.
🇺🇸Hamden, Connecticut, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
Great Falls Clinic
🇺🇸Great Falls, Montana, United States
Hematology Oncology Associates
🇺🇸Morristown, New Jersey, United States
Nassau Hematology/Oncology PC
🇺🇸Lake Success, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Buffalo Medical Group, P.C.
🇺🇸Williamsville, New York, United States
Lancaster Cancer Center
🇺🇸Lancaster, Pennsylvania, United States
Providence Hospital Cancer Center
🇺🇸Southfield, Michigan, United States
Cleveland Clinic Cancer Center
🇺🇸Cleveland, Ohio, United States
Peachtree Hematology and Oncology Consultants, P.C.
🇺🇸Atlanta, Georgia, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Lutheran General Cancer Care Center
🇺🇸Park Ridge, Illinois, United States
St. Joseph Oncology, Inc.
🇺🇸Saint Joseph, Missouri, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Cancer and Blood Institute of the Desert
🇺🇸Rancho Mirage, California, United States
nTouch Research
🇺🇸Melbourne, Florida, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Central Georgia Hematology Oncology, P.C.
🇺🇸Macon, Georgia, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Mid-Ohio Oncology/Hematology, Inc.
🇺🇸Columbus, Ohio, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Rainier Oncology
🇺🇸Puyallup, Washington, United States
UW Cancer Center Wausau Hospital
🇺🇸Wausau, Wisconsin, United States
Harbor Hospital Center
🇺🇸Baltimore, Maryland, United States
Oncology-Hematology Associates, P.A.
🇺🇸Clinton, Maryland, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Nevada Cancer Center
🇺🇸Las Vegas, Nevada, United States
Virginia Piper Cancer Institute
🇺🇸Minneapolis, Minnesota, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Cancer Therapy and Research Center
🇺🇸San Antonio, Texas, United States
Sarah Cannon-Minnie Pearl Cancer Center
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Intermountain Hematology/Oncology Associates, Inc.
🇺🇸Salt Lake City, Utah, United States
State University of New York Health Sciences Center - Stony Brook
🇺🇸Stony Brook, New York, United States
Midwest Hematology Oncology Consultants, Ltd.
🇺🇸Saint Louis, Missouri, United States
Providence Cancer Center
🇺🇸Mobile, Alabama, United States
Intouch Research
🇺🇸Huntsville, Alabama, United States
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Medical Oncology/Hematology
🇺🇸Gilroy, California, United States
California Cancer Care, Inc.
🇺🇸Greenbrae, California, United States
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Center for Cancer And Hematologic Disease
🇺🇸Cherry Hill, New Jersey, United States
Hematology and Oncology Group
🇺🇸Somerset, New Jersey, United States
Mary Imogene Bassett Hospital
🇺🇸Cooperstown, New York, United States
Lifespan: The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Medical Oncology Associates of Wyoming Valley, P.C.
🇺🇸Kingston, Pennsylvania, United States
Williamson Medical Center
🇺🇸Franklin, Tennessee, United States
Jackson-Madison County General Hospital
🇺🇸Jackson, Tennessee, United States
Central Utah Medical Clinic
🇺🇸Provo, Utah, United States
Scott and White Memorial Hospital
🇺🇸Temple, Texas, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Yakima Regional Cancer Care Center
🇺🇸Yakima, Washington, United States
Cancer Care Ontario - Windsor Regional Cancer Centre
🇨🇦Windsor, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
🇨🇦Sudbury, Ontario, Canada
Queen Elizabeth Hospital, PEI
🇨🇦Charlottetown, Prince Edward Island, Canada
CHUM Hopital Saint-Luc
🇨🇦Montreal, Quebec, Canada
Veterans Affairs Medical Center - San Juan
🇵🇷San Juan, Puerto Rico
Montreal General Hospital
🇨🇦Montreal, Quebec, Canada