Colorectal Cancer Clinical Trial
Official title:
Phase II and Pharmacokinetic Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) in Patients With Advanced Colorectal Cancer Who Have Failed Previous 5-FU Based Chemotherapy
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 advanced or recurrent colorectal cancer.
OBJECTIVES: I. Determine the objective response rate, overall survival, and time to disease
progression after maximal response in patients with advanced or metastatic colorectal cancer
treated with oral nitrocamptothecin. II. Determine the safety, toxicity, and
pharmacokinetics of this regimen in these patients.
OUTLINE: This is a multicenter study. 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 completion of course
8 may receive additional courses. Patients are followed every 3 months for 1 year or until
death.
PROJECTED ACCRUAL: Approximately 14-45 patients will be accrued for this study over less
than 1 year.
;
Primary Purpose: Treatment
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