Ketoconazole, Dexamethasone, and Hydrocortisone in Treating Patients With Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Studying samples of blood in the laboratory from patients with cancer receiving ketoconazole together with dexamethasone and hydrocortisone may help doctors learn more about how these drugs are used by the body.

PURPOSE: This randomized clinical trial is studying how ketoconazole, dexamethasone, and hydrocortisone act in the body of patients with prostate cancer that did not respond to androgen-deprivation therapy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Androgens; BB 1101; Cortisol succinate; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Ketoconazole

Criteria

DISEASE CHARACTERISTICS:

• Confirmed diagnosis of prostate cancer

• Must have failed standard androgen-deprivation therapy

• Evidence of rising PSA

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Creatinine ≤ 2.0 mg/dL

• AST and ALT < 4 times upper limit of normal

• Bilirubin < 2.0 mg/dL

• No active congestive heart failure

• No allergy to ketoconazole, dexamethasone, hydrocortisone, or to one of the components of dexamethasone, hydrocortisone, or ketoconazole

• No active infection

• No uncontrolled glaucoma

• No active peptic ulcer disease

• No uncontrolled diabetes mellitus

• Fertile patients must use effective contraception during and for 3 months after completion of study therapy

PRIOR CONCURRENT THERAPY:

• More than 2 weeks since prior and no concurrent drugs known to interact with study treatment