Aminocamptothecin in Treating Patients With Recurrent or Unresectable Epithelial Ovarian Cancer

This study has been completed.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00002671
First received: November 1, 1999
Last updated: November 8, 2012
Last verified: May 2006
  Purpose

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 Intervention Phase
Ovarian Cancer
Drug: aminocamptothecin
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Study Start Date: December 1995
Primary Completion Date: February 2001 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002671

Locations
United States, New Jersey
Riverview Medical Center
Red Bank, New Jersey, United States, 07701
Overlook Hospital
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
Sponsors and Collaborators
New York University School of Medicine
Eastern Cooperative Oncology Group
Investigators
Study Chair: Howard S. Hochster, MD New York University School of Medicine
  More Information

Additional Information:
Publications:
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.

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00002671     History of Changes
Other Study ID Numbers: CDR0000064290, NYU-9501, E-9501, NCI-T95-0001D
Study First Received: November 1, 1999
Last Updated: November 8, 2012
Health Authority: United States: Federal Government

Keywords provided by New York University School of Medicine:
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on April 15, 2014