Aminocamptothecin in Treating Patients With Recurrent or Unresectable Epithelial Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT00002671|
Recruitment Status : Completed
First Posted : May 24, 2004
Last Update Posted : November 9, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: aminocamptothecin||Phase 2|
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.)
|Study Type :||Interventional (Clinical Trial)|
|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|
|Actual Primary Completion Date :||February 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|New York Presbyterian Hospital - Cornell Campus|
|New York, New York, United States, 10021|
|Mount Sinai Medical Center, NY|
|New York, New York, United States, 10029|
|Study Chair:||Howard S. Hochster, MD||New York University School of Medicine|