Status:
COMPLETED
A Two-dose Level Clinical Trial of Itraconazole in Patients With Metastatic Prostate Cancer Who Have Had Disease Progression While on Hormonal Therapy
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Memorial Sloan Kettering Cancer Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This research is being done to test an investigational drug, called itraconazole, in the treatment of prostate cancer. Itraconazole is approved by the Food and Drug Administration (FDA) for the treatm...
Detailed Description
Itraconazole is an oral, generic, and commercially available antifungal drug with a long safety record when used at doses ranging from 200 to 600 mg daily. Itraconazole has been shown in cellular and...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed prostate adenocarcinoma.
- Presence of distant metastases on bone scan, CT scan, or MRI scan.
- Progression after androgen deprivation (and anti-androgen withdrawal).
- Rising serum PSA (Prostate Cancer Working Group (PCWG2) definition).
- Castrate levels of serum testosterone (i.e., ≤ 50 ng/dL).
- Age \> 18 years.
- ECOG performance status score ≤ 2, and/or Karnofsky score ≥ 50%.
- Life expectancy \> 6 months.
- Adequate kidney, liver, and bone marrow function.
- Willingness to sign informed consent and adhere to study requirements.
Exclusion
- Recent surgery, radiation therapy, combined androgen blockade, or investigational therapies in the last 8 weeks.
- Previous chemotherapy for metastatic prostate cancer.
- Concomitant use of second-line hormonal agents (e.g., ketoconazole, DES)
- Current use of corticosteroids, except if on a stable dose for ≥ 3 months.
- History of malabsorption syndrome (may affect itraconazole absorption).
- Allergic reactions to itraconazole or similar compounds.
- Concurrent use of drugs that interact with the CYP3A4 system (caution only).
- Presence of known brain metastases.
- Prior malignancy in the last 3 years, with some exceptions.
- Uncontrolled major infectious, cardiac, or pulmonary illnesses.
- Prolonged corrected QT interval (\> 450 msec) on electrocardiography.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00887458
Start Date
July 1 2009
End Date
December 1 2013
Last Update
October 16 2017
Active Locations (4)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
2
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
3
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
4
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021