Status:
COMPLETED
Ketoconazole, Hydrocortisone, and GM-CSF in Treating Patients With Progressive Prostate Cancer After Hormone Therapy
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
Up to 120 years
Phase:
PHASE2
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 t...
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 h...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Progressive disease after androgen deprivation AND meets 1 of the following criteria:
- Measurable disease
- Measurable lesions ≥ 10 mm with spiral CT
- Up to 5 lesions per organ and 10 lesions total should be identified as target lesions
- No measurable disease
- Patients with prostate-specific antigen (PSA)-only disease must have an elevated PSA
- PSA evidence for progressive disease consists of a PSA level of ≥ 5 ng/mL that has risen on ≥ 2 successive occasions, ≥ 2 weeks apart
- Patients with a positive bone scan must also 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
- Patients receiving flutamide must have had ≥ 1 of the PSA values obtained ≥ 4 weeks after flutamide discontinuation
- Patients receiving bicalutamide or nilutamide must have had ≥ 1 of the PSA values obtained ≥ 6 weeks after antiandrogen discontinuation
- Testosterone \< 50 ng/dL
- PSA ≥ 5 ng/mL
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- No serious intercurrent infections or nonmalignant uncontrolled medical illnesses
- No psychiatric illnesses OR social situations that would limit compliance
- No active or uncontrolled autoimmune disease
- ALT and AST normal
- Bilirubin normal
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1.5 times upper limit or normal (ULN)
- Hemoglobin ≥ 8 g/dL
- No other currently active malignancy except for nonmelanoma skin cancer
- No currently active malignancy defined as therapy completed with ≤ 30% risk of relapse
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Patients must continue primary androgen deprivation therapy with a luteinizing-hormone releasing-hormone (LHRH) analogue if they have not undergone orchiectomy
- No prior systemic chemotherapy for prostate cancer
- All other systemic chemotherapy must have been completed ≥ 2 years prior to study
- No other concurrent chemotherapy, immunotherapy, or radiotherapy
- Major surgery or radiation therapy completed ≥ 4 weeks prior to study
- No other concurrent corticosteroids, including routine use antiemetics
- No prior ketoconazole, aminoglutethimide, or corticosteroids for treatment of progressive prostate cancer
- No prior immunotherapy (e.g., vaccines or sargramostim GM-CSF)
- Patients receiving any other hormonal therapy (e.g., megestrol, finasteride, herbal product known to decrease PSA levels \[e.g., saw palmetto or PC-SPES\], or any systemic corticosteroid) must discontinue the agent ≥ 4 weeks prior to enrollment and progressive disease must be documented after discontinuation
- No initiation of bisphosphonate therapy within 1 month prior to starting study therapy
- Patients on stable doses that show tumor progression are allowed to continue bisphosphonate
- No concurrent supplements or complementary medicines/botanicals, except any combination of the following:
- Conventional multivitamin supplements
- Selenium
- Lycopene
- Soy supplements
- Vitamin E
- At least 8 weeks since prior radiopharmaceuticals (strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium)
- No other concurrent investigational or commercial anticancer agents or therapies
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00309894
Start Date
April 1 2004
End Date
December 1 2007
Last Update
August 5 2019
Active Locations (2)
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1
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
2
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States, 94121