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| Sponsor: | University of California, San Francisco |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00309894 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: sargramostim Drug: ketoconazole Drug: therapeutic hydrocortisone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label |
| Official Title: | Phase II Trial to Assess the Activity of Ketoconazole Plus GM-CSF in Patients With Prostate Cancer Progressive After Androgen Deprivation |
| Estimated Enrollment: | 48 |
| Study Start Date: | June 2006 |
OBJECTIVES:
Primary
Secondary
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.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Progressive disease after androgen deprivation AND meets 1 of the following criteria:
Measurable disease
No measurable disease
Patients with prostate-specific antigen (PSA)-only disease must have an elevated PSA
Patients who received prior antiandrogen as a part of primary androgen ablation therapy must demonstrate disease progression after discontinuation of the antiandrogen
Disease progression after antiandrogen withdrawal is defined as 2 consecutive rising PSA values obtained ≥ 2 weeks apart, or documented osseous or soft tissue progression
PATIENT CHARACTERISTICS:
No other currently active malignancy except for nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
No prior systemic chemotherapy for prostate cancer
No initiation of bisphosphonate therapy within 1 month prior to starting study therapy
No concurrent supplements or complementary medicines/botanicals, except any combination of the following:
Contacts and Locations| United States, California | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| Veterans Affairs Medical Center - San Francisco | |
| San Francisco, California, United States, 94121 | |
| Study Chair: | Charles Ryan, MD | University of California, San Francisco |
More Information
| Study ID Numbers: | CDR0000456193, UCSF-035516, UCSF-H45860-23833-02 |
| Study First Received: | March 29, 2006 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00309894 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate recurrent prostate cancer |
|
Anti-Inflammatory Agents Anti-Infective Agents Hydrocortisone Genital Neoplasms, Male Prostatic Diseases Cortisol succinate Urogenital Neoplasms Genital Diseases, Male |
Ketoconazole Pharmacologic Actions Neoplasms Neoplasms by Site Antifungal Agents Therapeutic Uses Hydrocortisone acetate Prostatic Neoplasms |