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

Alternate Title

Aminocamptothecin in Treating Patients With Recurrent Epithelial Ovarian Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	NCI-95-C-0056B NCI-CPB-357, NCI-T94-0164N, T94-0164

Objectives

I.  Assess the response rate to aminocamptothecin (9-AC) in patients with 
epithelial ovarian cancer recurrent after paclitaxel and platinum-based 
therapy.

II.  Study, in tumor tissue from selected patients, selected molecular 
endpoints that may be predictive of 9-AC activity, including topoisomerase I 
mRNA, DNA, and protein levels.

Entry Criteria

Disease Characteristics:

Histologically proven, advanced epithelial ovarian cancer
  Histologic confirmation by Pathology Department, NIH, required

  Recurrent disease after paclitaxel and either cisplatin or carboplatin
     Combination platinum/paclitaxel acceptable

Bidimensionally measurable disease on physical exam, radiographs, or
peritoneoscopy
  Repeat peritoneoscopy after 8 courses of therapy required if documentation
  of disease was solely by peritoneoscopy

  Laparotomy not required

No CNS metastasis

No borderline or mixed histology

Prior/Concurrent Therapy:

See Disease Characteristics
More than 4 weeks since any prior therapy and recovered
No prior camptothecin analogue-based chemotherapy
No prior radiotherapy except intraperitoneal 32-P

Patient Characteristics:

Age:
  18 and over

Performance status:
  ECOG 0-2

Hematopoietic:
  WBC greater than 3,000
  AGC greater than 1,500
  Platelets at least 100,000
  Hemoglobin greater than 9 g/dL OR
  Hematocrit greater than 27 g/dL

Hepatic:
  Bilirubin no greater than 1.5 mg/dL
  Serum transaminases no greater than 2 times normal

Renal:
  24-hour creatinine clearance greater than 45 mL/min (documented by NCI
  investigator or primary care physician)

Cardiovascular:
  No myocardial infarction within 12 months
  No active congestive heart failure
  No heart block
  No arrhythmia requiring medication

Other:
  No active uncontrolled infection
  No known HIV positivity
  No second malignancy currently under treatment except:
     Local basal cell carcinoma of the skin
     Cervical carcinoma in situ
     Other malignancies (e.g., stage I breast cancer) eligible at the
        discretion of the principal or associate investigators
  No pregnant women

Expected Enrollment

If at least 1 response is seen in the first 14 patients entered, up to 40 
patients will be accrued.  Accrual is expected to take 1-2 years.

Outline

Single-Agent Chemotherapy with Hematologic Toxicity Attenuation.  
Aminocamptothecin, 9-AC, NSC-603071; with Granulocyte Colony Stimulating 
Factor (Amgen), G-CSF, NSC-614629.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Eddie Reed, MD, Protocol chair(Contact information may not be current)		Ph: 304-293-4500; 877-427-2894