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
- Compare the survival of patients with unresectable locally advanced or metastatic
pancreatic cancer treated with triacetyluridine and high-dose fluorouracil vs
- 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
- 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
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.
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
Lenny Smith, MS
United States: Federal Government
|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|