A Phase II Evaluation Of CT-2103 (IND #61013) In The Third-Line Treatment Of Recurrent Or Persistent Epithelial Ovarian or Primary Peritoneal Cancer
OBJECTIVES:
- Determine the antitumor activity of polyglutamate paclitaxel (CT-2103) as third-line
treatment for patients with recurrent or persistent ovarian epithelial or primary
peritoneal cancer.
- Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive polyglutamate paclitaxel (CT-2103) IV over 10-20 minutes on day 1. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-22
months.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Paul Sabbatini, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000257039
NCT00045682
September 2002
Name | Location |
---|---|
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |