Gastric Cancer Clinical Trial
Official title:
A Phase II Study of RFS 2000 (Rubitecan, 9-Nitro-Camptothecin, 9-NC) in Patients With Advanced Gastric Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients
who have locally advanced or metastatic stomach cancer that cannot be removed during
surgery.
OBJECTIVES: I. Determine the objective response rate, progression-free survival, overall
survival, and time to treatment failure in patients with unresectable locally advanced or
metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with oral
nitrocamptothecin. II. Determine the toxicity of this regimen in these patients.
OUTLINE: Patients are stratified according to prior therapy (yes vs no). Patients receive
oral nitrocamptothecin on days 1-5. Treatment repeats every week for 8 courses in the
absence of disease progression or unacceptable toxicity. Patients with stable or responding
disease after week 8 may receive additional courses of therapy. Patients are followed every
3 months until death.
PROJECTED ACCRUAL: Approximately 21-55 patients will be accrued for this study.
;
Primary Purpose: Treatment
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