Spots Global Cancer Trial Database for TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

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Trial Identification

Brief Title: TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Official Title: A Phase II Study of TLK 286 in Platinum Resistant Advanced Epithelial Ovarian Cancer

Study ID: NCT00022347

Conditions

Fallopian Tube Cancer

Ovarian Cancer

Primary Peritoneal Cavity Cancer

Interventions

canfosfamide hydrochloride

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 TLK286 in treating patients who have advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.

Detailed Description: OBJECTIVES: I. Determine the objective response rate and disease stabilization rate in patients with platinum-resistant advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer treated with TLK286. II. Determine the safety of this regimen in these patients. III. Determine the duration of objective response, time to tumor progression, and overall survival in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive TLK286 IV over 30 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks for 1 year and then every 12 weeks thereafter. PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study within 12 months.