TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal 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.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Drug: canfosfamide hydrochloride
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of TLK 286 in Platinum Resistant Advanced Epithelial Ovarian Cancer|
- Objective response rate [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
- Duration of objective response [ Designated as safety issue: No ]
- Time to tumor progression [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||May 2001|
|Study Completion Date:||December 2009|
|Primary Completion Date:||April 2004 (Final data collection date for primary outcome measure)|
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.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||David R. Spriggs, MD||Memorial Sloan-Kettering Cancer Center|