Spots Global Cancer Trial Database for Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer

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Trial Identification

Brief Title: Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer

Official Title: Open Label Phase II Study on RFS 2000 (9-Nitro-camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Advanced Ovarian Cancer

Study ID: NCT00006230

Conditions

Ovarian 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 ovarian cancer.

Detailed Description: OBJECTIVES: * Determine the objective response rate and duration of response in patients with advanced ovarian cancer treated with nitrocamptothecin. * Determine the probability of objective response as expressed by the response rate in patients treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to disease status (sensitive vs refractory). Patients receive oral nitrocamptothecin daily for 5 consecutive days each week for 3 weeks. Treatment continues every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease (SD) receive up to 4 additional courses past SD. Patients who achieve partial response (PR) or complete response (CR) receive a minimum of 2 additional courses past PR or CR. Patients are followed every 6 weeks until disease progression or the initiation of another antitumor therapy. PROJECTED ACCRUAL: A total of 28-50 patients (14-25 per stratum) will be accrued for this study.