Pancreatic Cancer Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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