Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Aminocamptothecin in Treating Patients With Recurrent or Unresectable Epithelial Ovarian Cancer

Basic Trial Information

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.

Entry 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

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
 

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 

Expected Enrollment

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.)

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.

Hochster H, Plimack ER, Runowicz CD, et al.: 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 22 (1): 120-6, 2004.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

NYU Cancer Institute at New York University Medical Center

Howard Hochster, MD, Protocol chair		Ph: 212-731-5100 Email: howard.hochster@med.nyu.edu

Eastern Cooperative Oncology Group

Howard Hochster, MD, Protocol chair		Ph: 212-731-5100 Email: howard.hochster@med.nyu.edu

Registry Information
Official Title		PHASE II STUDY OF 9-20-S-AMINO-CAMPTOTHECIN (9-AC) AS SECOND LINE THERAPY IN ADVANCED OVARIAN CARCINOMA
Trial Start Date		1995-12-05
Registered in ClinicalTrials.gov		NCT00002671
Date Submitted to PDQ		1995-12-05
Information Last Verified		2006-05-09
NCI Grant/Contract Number		CA63422

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