Spots Global Cancer Trial Database for Nitrocamptothecin in Treating Patients With Advanced or Recurrent Colorectal Cancer

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Trial Identification

Brief Title: Nitrocamptothecin in Treating Patients With Advanced or Recurrent Colorectal Cancer

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

Study ID: NCT00005877

Conditions

Colorectal Cancer

Interventions

rubitecan

Study Description

Brief Summary: 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.

Detailed Description: 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.