Gastric Cancer Clinical Trial
Official title:
A Phase II Study of PN-401, 5-FU and Leucovorin in Unresectable or Metastatic Adenocarcinoma of the Stomach
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Chemoprotective drugs such as triacetyluridine may protect
normal cells from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of triacetyluridine, fluorouracil, and
leucovorin in treating patients who have unresectable, locally advanced, or metastatic
cancer of the esophagus or stomach.
OBJECTIVES:
- Assess the 6-month survival rate in patients with unresectable, locally advanced or
metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with
triacetyluridine, fluorouracil, and leucovorin calcium.
- Evaluate the qualitative and quantitative toxic effects of this regimen in these
patients.
OUTLINE: This is a multicenter study.
Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 30 minutes
beginning 1 hour into leucovorin calcium infusion on days 1, 8, 15, 22, 29, and 36. Patients
receive oral triacetyluridine every 8 hours on days 1-3, 8-10, 15-17, 22-24, 29-31, and
36-38 beginning 8 hours after completion of each fluorouracil infusion. Courses repeat every
8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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