Ketoconazole, Hydrocortisone, and GM-CSF in Treating Patients With Progressive Prostate Cancer After Hormone Therapy
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|ClinicalTrials.gov Identifier: NCT00309894|
Recruitment Status : Completed
First Posted : April 3, 2006
Last Update Posted : October 11, 2012
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 or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: sargramostim Drug: ketoconazole Drug: therapeutic hydrocortisone||Phase 2|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Masking:||None (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|
|Study Start Date :||April 2004|
|Primary Completion Date :||November 2007|
|Study Completion Date :||December 2007|
- Time to progression
- Response rate as measured by prostate-specific antigen and objective parameters
- Frequency of grades 3-4 toxicity
- Pattern of immune response as measured by immunohistochemistry
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309894
|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|