Ketoconazole, Hydrocortisone, and GM-CSF in Treating Patients With Progressive Prostate Cancer After Hormone Therapy

Phase 2

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00309894
• Lead Sponsor: University of California, San Francisco

Brief Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as ketoconazole, may stop the adrenal glands from making androgens. GM-CSF may help ketoconazole work better by making tumor cells more sensitive to the drug. Giving ketoconazole together with hydrocortisone and GM-CSF may be an effective treatment for prostate cancer.

PURPOSE: This phase II trial is studying how well giving ketoconazole together with hydrocortisone and GM-CSF works in treating patients with progressive prostate cancer after hormone therapy.

Detailed Description

OBJECTIVES:

Primary

* Evaluate the effect of ketoconazole, hydrocortisone, and sargramostim (GM-CSF) on time to clinical progression in patients with prostate cancer that has progressed on primary hormonal therapy.

Secondary

* Evaluate the objective response frequency in patients treated with this regimen.

* Investigate the safety of this regimen.

OUTLINE: This is an open-label, nonrandomized study.

Patients receive oral ketoconazole three times daily and oral hydrocortisone twice daily on days 1-28 and sargramostim (GM-CSF) subcutaneously on days 15-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2006-03-29
• Study First Submitted QC: 2006-03-29
• Study First Posted: 2006-04-03
• Primary Completion: 2007-11
• Study Completion: 2007-12
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-01
• Last Update Posted: 2019-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to progression

Secondary Outcome Measures

Name	Time	Method
Frequency of grades 3-4 toxicity
Response rate as measured by prostate-specific antigen and objective parameters
Pattern of immune response as measured by immunohistochemistry

Trial Locations

Locations (2)

UCSF Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

Veterans Affairs Medical Center - San Francisco; 🇺🇸 San Francisco, California, United States