Ovarian Cancer Clinical Trial
Official title:
A Phase II Study of TLK 286 in Platinum Resistant Advanced Epithelial Ovarian Cancer
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.
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.
;
Primary Purpose: Treatment
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