S9700 Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00003018
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemotherapy following surgery may be an effective treatment for pancreatic cancer.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with stage II or stage III pancreatic cancer that has not been surgically removed.
- Detailed Description
OBJECTIVES: I. Assess the one year overall survival rate of patients with advanced, unresectable pancreatic cancer treated with fluorouracil, leucovorin, mitomycin and dipyridamole. II. Assess the response rate in this group of patients. III. Evaluate the frequency and severity of the toxic effects associated with this therapy. IV. Assess the rate of resectability in patients who respond to therapy.
OUTLINE: All patients undergo surgical placement of an indwelling central venous line. Patients receive fluorouracil IV by continuous infusion on days 1-28, leucovorin calcium IV on days 1, 8, 15, and 22, oral dipyridamole on days 1-28, and mitomycin IV every 6 weeks starting on day 1. Treatment repeats every 6 weeks for 4 courses. Patients with a partial or complete response are reevaluated for possible surgical resection. Resected patients resume chemotherapy 4-8 weeks after surgery for an additional 16 weeks. Patients are followed every 6 months for 2 years, then annually until death.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chemotherapy leucovorin calcium dipyridamole: 75mg/dose, PO, Days 1-28 of 5 week cycle; fluorouracil: 200 mg/m\^2/day, continuous IV, Days 1-28 of 5 week cycle; leucovorin calcium: 30 mg/m\^2/day, IV, Days 1,8,15,22 of 5 week cycle; mitomycin C: 10 mg/m\^2, IV, Day 1 of 6 week cycle (for only 4 cycles) Chemotherapy dipyridamole dipyridamole: 75mg/dose, PO, Days 1-28 of 5 week cycle; fluorouracil: 200 mg/m\^2/day, continuous IV, Days 1-28 of 5 week cycle; leucovorin calcium: 30 mg/m\^2/day, IV, Days 1,8,15,22 of 5 week cycle; mitomycin C: 10 mg/m\^2, IV, Day 1 of 6 week cycle (for only 4 cycles) Chemotherapy fluorouracil dipyridamole: 75mg/dose, PO, Days 1-28 of 5 week cycle; fluorouracil: 200 mg/m\^2/day, continuous IV, Days 1-28 of 5 week cycle; leucovorin calcium: 30 mg/m\^2/day, IV, Days 1,8,15,22 of 5 week cycle; mitomycin C: 10 mg/m\^2, IV, Day 1 of 6 week cycle (for only 4 cycles) Chemotherapy mitomycin C dipyridamole: 75mg/dose, PO, Days 1-28 of 5 week cycle; fluorouracil: 200 mg/m\^2/day, continuous IV, Days 1-28 of 5 week cycle; leucovorin calcium: 30 mg/m\^2/day, IV, Days 1,8,15,22 of 5 week cycle; mitomycin C: 10 mg/m\^2, IV, Day 1 of 6 week cycle (for only 4 cycles)
- Primary Outcome Measures
Name Time Method Overall Survival One year
- Secondary Outcome Measures
Name Time Method Toxicities From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months Resectability of patents who respond to this regimen From date of registration until the date of patients achieving complete or partial response assessed up to 100 months Response rate in patients with measurable disease From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Trial Locations
- Locations (84)
MBCCOP - University of South Alabama
🇺🇸Mobile, Alabama, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Veterans Affairs Medical Center - Jackson
🇺🇸Jackson, Mississippi, United States
CCOP - Dayton
🇺🇸Kettering, Ohio, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle
🇺🇸Seattle, Washington, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Veterans Affairs Outpatient Clinic - Martinez
🇺🇸Martinez, California, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Veterans Affairs Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
🇺🇸San Antonio, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City
🇺🇸Salt Lake City, Utah, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Hayden)
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - Detroit
🇺🇸Detroit, Michigan, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Oklahoma Medical Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Portland
🇺🇸Portland, Oregon, United States
Oregon Cancer Center at Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
Veterans Affairs Medical Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
Providence Hospital - Southfield
🇺🇸Southfield, Michigan, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
🇺🇸Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Biloxi
🇺🇸Biloxi, Mississippi, United States
CCOP - Grand Rapids Clinical Oncology Program
🇺🇸Grand Rapids, Michigan, United States
Keesler Medical Center - Keesler AFB
🇺🇸Keesler AFB, Mississippi, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Veterans Affairs Medical Center - Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Veterans Affairs Medical Center - Long Beach
🇺🇸Long Beach, California, United States
Beckman Research Institute, City of Hope
🇺🇸Los Angeles, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
Dwight David Eisenhower Army Medical Center
🇺🇸Fort Gordon, Georgia, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
🇺🇸Hines, Illinois, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
🇺🇸Jamaica Plain, Massachusetts, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Texas Tech University Health Science Center
🇺🇸Lubbock, Texas, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Veterans Affairs Medical Center - Temple
🇺🇸Temple, Texas, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
MBCCOP - LSU Medical Center
🇺🇸New Orleans, Louisiana, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - Kansas City
🇺🇸Kansas City, Missouri, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Veterans Affairs Medical Center - New Orleans
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
Veterans Affairs Medical Center - Lexington
🇺🇸Lexington, Kentucky, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Veterans Affairs Medical Center - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
MBCCOP - University of New Mexico HSC
🇺🇸Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States