Spots Global Cancer Trial Database for Aminocamptothecin in Treating Patients With Recurrent or Unresectable Epithelial Ovarian Cancer
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Trial Identification
Brief Title: Aminocamptothecin in Treating Patients With Recurrent or Unresectable Epithelial Ovarian Cancer
Official Title: PHASE II STUDY OF 9-20-S-AMINO-CAMPTOTHECIN (9-AC) AS SECOND LINE THERAPY IN ADVANCED OVARIAN CARCINOMA
Study ID: NCT00002671
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.)
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Riverview Medical Center, Red Bank, New Jersey, United States
Overlook Hospital, Summit, New Jersey, United States
Albert Einstein Comprehensive Cancer Center, Bronx, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States
New York Presbyterian Hospital - Cornell Campus, New York, New York, United States
Mount Sinai Medical Center, NY, New York, New York, United States
Contact Details
Name: Howard S. Hochster, MD
Affiliation: NYU Langone Health
Role: STUDY_CHAIR
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