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	any age	NCI	CCUM-9508 NCI-T95-0028H, T95-0028

Objectives

I.  Assess the efficacy and feasibility of aminocamptothecin (9-AC) in the 
treatment of patients with advanced hormone-refractory prostate cancer.

II.  Evaluate the toxicity of 9-AC in these patients.

Entry Criteria

Disease Characteristics:

Histologically confirmed adenocarcinoma of the prostate

Stage D2 disease refractory to hormonal therapy

PSA greater than 10 ng/ml

Bidimensionally measurable soft tissue disease or evaluable disease required
  Abnormal bone scan and/or elevated PSA considered evaluable

No brain metastasis
No spinal cord compression

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  Failed prior hormonal therapy
  At least 4 weeks since flutamide and no subsequent decrease in PSA
  LHRH analogue therapy continued in non-orchiectomized patients

Radiotherapy:
  At least 4 weeks since radiotherapy

Surgery:
  Not specified

Patient Characteristics:

Age:
  Any age

Performance status:
  Zubrod 0-2

Life expectancy:
  At least 12 weeks

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

Hepatic:
  Bilirubin no greater than 1.5 x ULN
  SGOT no greater than 3 x ULN

Renal:
  Creatinine no greater than 1.5 mg/dl

Cardiovascular:
  No MI within 1 year

Other:
  No active infection
  No poorly controlled diabetes mellitus
  No medical contraindication to protocol therapy
  No second malignancy within 5 years except:
    Nonmelanomatous skin cancer
    In situ carcinoma of any site

Expected Enrollment

Up to 40 patients will be entered over 6 months; if none of the first 12 
patients responds after 16 weeks of treatment, the study will close.

Outline

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

Trial Contact Information

Trial Lead Organizations

University of Michigan Comprehensive Cancer Center

Kenneth Pienta, MD, FACP, Protocol chair		Ph: 734-936-1831; 800-865-1125