Aminocamptothecin in Treating Patients With Recurrent or Unresectable 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 aminocamptothecin in treating patients with recurrent or unresectable epithelial ovarian cancer that has been previously treated with platinum-based chemotherapy.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||PHASE II STUDY OF 9-20-S-AMINO-CAMPTOTHECIN (9-AC) AS SECOND LINE THERAPY IN ADVANCED OVARIAN CARCINOMA|
|Study Start Date:||December 1995|
|Primary Completion Date:||February 2001 (Final data collection date for primary outcome measure)|
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.)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002671
|United States, New Jersey|
|Riverview Medical Center|
|Red Bank, New Jersey, United States, 07701|
|Summit, New Jersey, United States, 07902-0220|
|United States, New York|
|Albert Einstein Comprehensive Cancer Center|
|Bronx, New York, United States, 10461|
|Mount Sinai Medical Center, NY|
|New York, New York, United States, 10029|
|New York Presbyterian Hospital - Cornell Campus|
|New York, New York, United States, 10021|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|Study Chair:||Howard S. Hochster, MD||New York University School of Medicine|