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An Open Label, Randomized, Controlled, Phase III, Multi-center, Clinical Trial Of PN401 With High Dose 5-Fluorouracil (5FU) Versus Gemcitabine For Treatment Of Patients With Advanced Pancreatic Cancer
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Northwest Oncology and Hematology Associates
Coral Springs, Florida, United States
Florida Cancer Specialists - World Plaza
Fort Myers, Florida, United States
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States
Florida Oncology Associates - South Side
Jacksonville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Start Date
February 1, 2001
Primary Completion Date
February 1, 2006
Last Updated
June 28, 2012
250
ACTUAL participants
fluorouracil
DRUG
gemcitabine hydrochloride
DRUG
triacetyluridine
DRUG
Lead Sponsor
Wellstat Therapeutics
NCT05053971
NCT04550494
Data Source & Attribution
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