Overview

Aminocamptothecin in Treating Patients With Recurrent or Unresectable Epithelial Ovarian Cancer

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New York University School of Medicine
NYU Langone Health
Collaborators:
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
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