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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Open Label Randomized Phase 3 Multi-Center Trial of PN401 plus high dose 5-FU versus Gemcitabine in Advanced Pancreatic Cancer Patients
Disease progression
No
Lenny Smith, MS
Study Chair
Wellstat Therapeutics
United States: Federal Government
CDR0000068931
NCT00024427
February 2001
Name | Location |
---|---|
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Fox Chase - Temple Cancer Center | Philadelphia, Pennsylvania 19111-2442 |
Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Capitol Comprehensive Cancer Care Clinic | Jefferson City, Missouri 65109 |
Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham, Alabama 35294 |
Scripps Cancer Center at Scripps Clinic | La Jolla, California 92037 |
David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
Memorial Cancer Institute at Memorial Regional Hospital | Hollywood, Florida 33021 |
New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
Cancer Care Center | New Albany, Indiana 47150 |
Cancer Centers of the Carolinas - Eastside | Greenville, South Carolina 29601 |
Cancer Center at Greater Baltimore Medical Center | Baltimore, Maryland 21204 |
Queens Medical Associates, PC | Fresh Meadows, New York 11365 |
Corpus Christi Cancer Center | Corpus Christi, Texas 78412 |
Brookwood Medical Center | Birmingham, Alabama 35209-6804 |
Northwest Oncology and Hematology Associates | Coral Springs, Florida 33065 |
Florida Cancer Specialists - World Plaza | Fort Myers, Florida 33908 |
Florida Oncology Associates - South Side | Jacksonville, Florida 32207 |
Florida Cancer Institute - New Port Richey | New Port Richey, Florida 34655 |
St. Joseph's Hospital | Savannah, Georgia 31419 |
Wellstat Therapeutics | Gaithersburg, Maryland 20878 |
Summit Oncology Associates | Akron, Ohio 44304 |