Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer
- Conditions
- Drug/Agent Toxicity by Tissue/OrganPancreatic Cancer
- Registration Number
- NCT00024427
- Lead Sponsor
- Wellstat Therapeutics
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells. Chemoprotective drugs such as triacetyluridine may protect normal cells from the side effects of chemotherapy. It is not yet known which chemotherapy regimen is more effective in treating pancreatic cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil plus triacetyluridine with that of gemcitabine in treating patients who have locally advanced or metastatic pancreatic cancer that cannot be treated with surgery.
- Detailed Description
OBJECTIVES:
* Compare the survival of patients with unresectable locally advanced or metastatic pancreatic cancer treated with triacetyluridine and high-dose fluorouracil vs gemcitabine.
* Compare the time to tumor progression, overall response rate, and response duration in patients treated with these regimens.
* Compare the safety of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to disease stage (II or III vs IV). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive high-dose fluorouracil (5-FU) IV over 30 minutes once weekly on weeks 1-3 followed by 1 week of rest. After each dose of 5-FU, patients receive oral triacetyluridine every 8 hours for a total of 8 doses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 followed by 1 week of rest (course 1). Subsequent courses are given on weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 260 patients (130 per treatment arm) will be accrued for this study within 30 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Open Label Randomized Phase 3 Multi-Center Trial of PN401 plus high dose 5-FU versus Gemcitabine in Advanced Pancreatic Cancer Patients Disease progression
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
University of Miami Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Cancer Center at Greater Baltimore Medical Center
🇺🇸Baltimore, Maryland, United States
Fox Chase - Temple Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Summit Oncology Associates
🇺🇸Akron, Ohio, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
Queens Medical Associates, PC
🇺🇸Fresh Meadows, New York, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Corpus Christi Cancer Center
🇺🇸Corpus Christi, Texas, United States
Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus
🇨🇦Ottawa, Ontario, Canada
McGill Cancer Centre at McGill University
🇨🇦Montreal, Quebec, Canada
Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
🇨🇦Thunder Bay, Ontario, Canada
Brookwood Medical Center
🇺🇸Birmingham, Alabama, United States
Comprehensive Cancer Center at University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Providence Saint Joseph Medical Center - Burbank
🇺🇸Burbank, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Scripps Cancer Center at Scripps Clinic
🇺🇸La Jolla, California, United States
Florida Cancer Specialists - World Plaza
🇺🇸Fort Myers, Florida, United States
Northwest Oncology and Hematology Associates
🇺🇸Coral Springs, Florida, United States
Florida Oncology Associates - South Side
🇺🇸Jacksonville, Florida, United States
Memorial Cancer Institute at Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Florida Cancer Institute - New Port Richey
🇺🇸New Port Richey, Florida, United States
St. Joseph's Hospital
🇺🇸Savannah, Georgia, United States
Cancer Care Center
🇺🇸New Albany, Indiana, United States
Wellstat Therapeutics
🇺🇸Gaithersburg, Maryland, United States
Capitol Comprehensive Cancer Care Clinic
🇺🇸Jefferson City, Missouri, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
University of New Mexico Cancer Research and Treatment Center
🇺🇸Albuquerque, New Mexico, United States
David C. Pratt Cancer Center at St. John's Mercy
🇺🇸Saint Louis, Missouri, United States
Cancer Centers of the Carolinas - Eastside
🇺🇸Greenville, South Carolina, United States