Aminocamptothecin in Treating Patients With Recurrent or Unresectable Epithelial Ovarian Cancer

November 8, 2012 updated by: NYU Langone Health

PHASE II STUDY OF 9-20-S-AMINO-CAMPTOTHECIN (9-AC) AS SECOND LINE THERAPY IN ADVANCED OVARIAN CARCINOMA

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 Overview

Status

Completed

Conditions

Ovarian Cancer

Intervention / Treatment

Drug: aminocamptothecin

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.)

Study Type

Interventional

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New Jersey
  - Red Bank, New Jersey, United States, 07701
    - Riverview Medical Center
  - Summit, New Jersey, United States, 07902-0220
    - Overlook Hospital
- New York
  - Bronx, New York, United States, 10461
    - Albert Einstein Comprehensive Cancer Center
  - New York, New York, United States, 10016
    - NYU School of Medicine's Kaplan Comprehensive Cancer Center
  - New York, New York, United States, 10021
    - New York Presbyterian Hospital - Cornell Campus
  - New York, New York, United States, 10029
    - Mount Sinai Medical Center, NY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS: Histologically proven advanced, recurrent, or inoperable ovarian epithelial cancer Previously treated with 1 platinum-containing chemotherapy regimen Bidimensionally measurable or reproducibly measurable disease in 2 dimensions on CT scan (The measurable disease stratum closed to accrual effective 08/1998) OR Evaluable but radiographically nonmeasurable disease with CA-125 more than 50 units/mL on 2 measurements at least 1 week apart

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No myocardial infarction, congestive heart failure, or other significant cardiac disease within the past 6 months No uncontrolled hypertension Other: No significant active infection (e.g., pneumonia, peritonitis, or wound abscess) No uncontrolled metabolic disease (e.g., diabetes mellitus or hypothyroidism) No asthma (even if controlled with medication) No other serious concurrent illness No dementia or altered mental status that would preclude informed consent No other malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See Disease Characteristics No more than 1 prior chemotherapy regimen No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: See Disease Characteristics Other: At least 4 weeks since prior investigational agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Hochster H, Plimack ER, Runowicz CD, Speyer J, Wallach RC, Sorich J, Mandeli J, Wadler S, Wright J, Muggia FM. Biweekly 72-hour 9-aminocamptothecin infusion as second-line therapy for ovarian carcinoma: phase II study of the New York Gynecologic Oncology Group and the Eastern Cooperative Oncology Group. J Clin Oncol. 2004 Jan 1;22(1):120-6. doi: 10.1200/JCO.2004.03.016.
Speyer JL, Hochster H, Runowicz C, et al.: Phase II study of 72 hr 9-amino-camptothecin (9AC) infusion in second-line therapy of ovarian cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A1401, 363a, 1999.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1995

Primary Completion (Actual)

February 1, 2001

Study Completion

December 6, 2022

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

May 21, 2004

First Posted (Estimate)

May 24, 2004

Study Record Updates

Last Update Posted (Estimate)

November 9, 2012

Last Update Submitted That Met QC Criteria

November 8, 2012

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000064290
NYU-9501
E-9501
NCI-T95-0001D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.