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 Closed 40 to 85 MSKCC-88142 NCI-V89-0048

Objectives

I.  Determine the efficacy of MK-906, as measured by decrease in serum 
prostatic-specific antigen and acid phosphatase, decrease in tumor size, and 
lack of deterioration in Karnofsky performance rating, in patients with Stage 
D prostatic cancer.
II.  Evaluate the toxicity of MK-906 in this patient population.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients between the ages of 40 and 
85 years with biopsy-confirmed (at Memorial Sloan-Kettering Cancer Center) 
Stage D adenocarcinoma of the prostate who have had no prior hormonal therapy 
or orchiectomy and who would be considered for hormonal manipulation, and, in 
the best judgment of the physician, would not receive any medical treatment 
during the time of this study; concomitant hormonal therapy is not allowed.  
Asymptomatic patients with elevated serum prostatic-specific antigen (PSA) or 
acid phosphatase (AP) are eligible, but those with abnormal liver function or 
evidence of metastases to the liver are ineligible.  At least 3 months must 
have elapsed since prior therapy with any other investigational drug or 
chemotherapeutic regimen.  A Karnofsky performance status of at least 50% and 
a life expectancy of more than 1 year are required, as is adequate renal 
function (creatinine no more than 2.0 mg/dl).  The following conditions 
exclude:  history of drug or alcohol abuse; chronic concurrent use of 
barbiturates, anticoagulants, theophylline, quinidine or other antiarrhythmia 
agents, or drugs with antiandrogenic properties (cimetidine, spironolactone); 
clinical findings suggestive of impending spinal cord compression; and a 
history of any illness that, in the opinion of the investigator, might obscure 
the results of the study or pose additional risks in administering MK-906.  
All screening evaluations must be performed within 6 weeks prior to initiating 
therapy.

Expected Enrollment

28 patients (14 per arm) will be entered.

Outline

Randomized, double-blind study.
Arm I:  Hormonal Therapy.  5a-Reductase Inhibition.  MK-906.
Arm II:  Placebo.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

William R. Fair, MD, Protocol chair(Contact information may not be current)		Ph: 212-639-4710; 800-525-2225 Email: fairw@mskcc.org