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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

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


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.)

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Howard S. Hochster, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Federal Government

Study ID:

CDR0000064290

NCT ID:

NCT00002671

Start Date:

December 1995

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • Ovarian Neoplasms

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
Mount Sinai Medical Center, NYNew York, New York  10029
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Riverview Medical CenterRed Bank, New Jersey  07701
Overlook HospitalSummit, New Jersey  07902-0220