Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	MSKCC-94126 NCI-T94-0127D, T94-0127

Objectives

I.  Estimate the activity of aminocamptothecin (9-AC) given in a fixed dose to 
patients with advanced ovarian cancer.

II.  Describe the acute and chronic toxicities of 9-AC on this schedule.

III.  Compare pharmacokinetic data from this study with previously obtained 
pharmacokinetic data for 9-AC given as a 72-hour infusion.

IV.  Correlate response to and toxicity of 9-AC with peak concentrations, 
steady-state levels, and/or area under the curve of total drug or lactone 
plasma concentrations.

V.  Correlate response with quality-of-life outcomes, including symptom 
distress, performance status, and global quality of life.

Entry Criteria

Disease Characteristics:

Histologically confirmed epithelial ovarian cancer previously treated with
paclitaxel and either cisplatin or carboplatin
  Pathology confirmed at Memorial Sloan-Kettering Cancer Center

Bidimensionally measurable disease outside any previously irradiated field

No CNS metastases or carcinomatous meningitis

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  Up to 2 prior chemotherapy regimens allowed
  Prior paclitaxel and either cisplatin or carboplatin required
  At least 4 weeks since myelosuppressive chemotherapy and recovered
  No prior aminocamptothecin or any other camptothecins

Endocrine therapy:
  Not specified

Radiotherapy:
  At least 4 weeks since radiotherapy to major bone marrow sites

Surgery:
  Not specified

Patient Characteristics:

Age: 
  18 and over

Performance status:
  Karnofsky 70-100%

Hematopoietic:
  AGC at least 1,500
  Platelets at least 100,000

Hepatic:
  Bilirubin no greater than 1.5 mg/dl
 
Renal:
  Creatinine no greater than 1.5 mg/dl

Cardiovascular:
  No MI within the past 6 months
  No current or prior NYHA class III/IV status

Other:
  No active or uncontrolled infection
  No medical or psychiatric conditions posing risks for participation
  No pregnant or nursing women
  Effective contraception required of fertile patients

Blood/body fluid analyses and physical exams to determine eligibility
completed within 14 days prior to registration; imaging studies and other
screening exams completed within 21 days prior to registration

Expected Enrollment

Up to 30 patients per treatment stratum will be entered over 2-2.5 years.  If 
no CR or PR occurs in the first 14 patients in a group, accrual to that 
stratum will cease.

Outline

Single-Agent Chemotherapy.  Aminocamptothecin, 9-AC, NSC-603071.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

David R. Spriggs, MD, Protocol chair		Ph: 212-639-2203; 800-525-2225