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Phase II Pilot Randomized, Double-Blind Study of MK-906 vs Placebo in Patients with Stage D Adenocarcinoma of the Prostate (Summary Last Modified 06/89)
Basic Trial Information
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 Lead Organizations Memorial Sloan-Kettering Cancer Center
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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