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

Alternate Title

Sedoxantrone Trihydrochloride in Treating Patients With Hormone-Refractory Metastatic Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI OSU-9617 CWRU-1897, OSU-T96-0054, NCI-T96-0054D, T96-0054

Objectives

I.  Evaluate the objective response rate of CI-958 in patients with hormone 
resistant prostate cancer.

II. Define the qualitative and quantitative toxic effects of CI-958 in the 
treated patients.

Entry Criteria

Disease Characteristics:

Histologically proven metastatic adenocarcinoma of the prostate
  Advanced stage D1 or D2 disease with evidence of progression following
  endocrine therapy (surgical or medical) eligible

Disease evident (not necessarily measurable) on x-ray, CT/bone scan, or
physical exam

Evaluable or measurable disease required in first stage of study

Beyond first stage, bidimensionally measurable disease required
  Patients without bidimensionally measurable disease must be evaluable by PSA
  level at least 20 mg/mL (10 mg/mL if prostate has been removed) which has   

  risen by 10% from previous baseline after hormone therapy

Patients without surgical orchiectomy should be maintained on luteinizing
hormone-releasing hormone (LHRH) analog

Prior/Concurrent Therapy:

Biologic therapy:
  No prior or concurrent biologic therapy

Chemotherapy:
  No prior or concurrent chemotherapy

Endocrine therapy:
  No concurrent hormonal therapy (except LHRH analogs)

Radiotherapy:
  At least 4 weeks since radiotherapy limited to less than 25% bone marrow

Surgery:
  At least 4 weeks since surgery and recovered (2 weeks for TURP)

Other:
  No concurrent corticosteroids
  No other concurrent investigational drug therapy
  At least 4 weeks since any treatment and recovered
  No flutamide, bicalutamide, nilutamide, or other antiandrogenic agents used
   for more than 2 months (patients are not eligible until response to
   antiandrogen withdrawal has been assessed)

Patient Characteristics:

Age:
  18 and over

Performance status:
  ECOG 0-2

Life expectancy:
  At least 6 months

Hematopoietic:
  Granulocyte count at least 1,500/mm3
  Platelet count at least 100,000/mm3

Hepatic:
  Bilirubin no greater than 2.0 mg/dL
  AST and ALT no greater than 1.5 times normal

Renal:
  Creatinine no greater than normal

Cardiovascular:
  No congestive heart failure
  No myocardial infarction within 6 months
  No arrhythmia
  No ischemic heart disease
  Left ventricular ejection fraction 50-100%

Other:
  No other serious illness
  No serious active infection
  No participation in another clinical trial
  No second malignancy within 5 years except:
     Nonmelanomatous skin cancer
     Superficial transitional cell carcinoma of the bladder

Expected Enrollment

In the first stage, a total of 20 patients will be accrued.  In the second and 
third stage, if there are 2 or more responses in the first 12 patients, an 
additional 23 patients will be accrued.

Outline

All patients receive CI-958 intravenously.  Treatment repeats every 21 days 
unless disease progression or unacceptable toxicity occurs.

Patients are followed until any toxicity is resolved and at least 30 days 
after last treatment.

Trial Contact Information

Trial Lead Organizations

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

J. Philip Kuebler, MD, PhD, Protocol chair		Ph: 614-442-3130 Email: pkuebler@coinc.net