drugset / Trial / NCT00309894
Ketoconazole, Hydrocortisone, and GM-CSF in Treating Patients With Progressive Prostate Cancer After Hormone Therapy
Phase 2
Completed
49 enrolled
University of California, San Francisco
National Cancer Institute (NCI) · collab
Non-randomizedOpen-labelTreatment
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.
Timeline
- Start
- 2004-04
- Primary completion
- 2007-11
- Completion
- 2007-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydrocortisone | Other / unclassified | — | Oral |
| Subject | Ketoconazole | Small molecule | — | Oral |
| Subject | sargramostim | Protein / enzyme biologic | — | Subcutaneous |