PHASE II STUDY OF 9-20-S-AMINO-CAMPTOTHECIN (9-AC) AS SECOND LINE THERAPY IN ADVANCED OVARIAN CARCINOMA
OBJECTIVES: I. Determine the objective response rate in patients with advanced, recurrent,
or inoperable ovarian epithelial cancer treated with aminocamptothecin as second-line
therapy. II. Determine the toxic effects of this regimen in these patients. III. Correlate
the topoisomerase-I levels with response in patients with accessible tumors treated with
this regimen.
OUTLINE: Patients are stratified according to disease (measurable vs nonmeasurable). (The
measurable disease stratum closed to accrual effective 08/1998.) Patients receive
aminocamptothecin IV continuously on days 1-3. Courses repeat every 2 weeks in the absence
of disease progression or unacceptable toxicity. Patients who achieve complete response (CR)
receive 4 additional courses past CR. Patients are followed every 3 months for 2 years,
every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study
within approximately 15 months. (The measurable disease stratum closed to accrual effective
08/1998.)
Interventional
Primary Purpose: Treatment
Howard S. Hochster, MD
Study Chair
New York University School of Medicine
United States: Federal Government
CDR0000064290
NCT00002671
December 1995
Name | Location |
---|---|
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
Mount Sinai Medical Center, NY | New York, New York 10029 |
New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
Riverview Medical Center | Red Bank, New Jersey 07701 |
Overlook Hospital | Summit, New Jersey 07902-0220 |