A Two-dose Level Clinical Trial of Itraconazole in Patients With Metastatic Prostate Cancer Who Have Had Disease Progression While on Hormonal Therapy

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Male

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 treatment of various fungal infections such as fingernail/toenail infections and other more serious fungal infections. The word "investigational" means that itraconazole is not approved for use in people with cancer. However, the FDA is allowing the use of itraconazole in this research study. Itraconazole has been shown to have activity against cancer (including prostate cancer) in the laboratory, but has not been tested against cancer in humans.

The purpose of this study is to find out:

• If itraconazole is safe when given at two different doses

• How itraconazole affects prostate specific antigen (PSA): a blood test that measures substances released by prostate cancer

• Whether itraconazole can delay further prostate cancer growth and spread

• How itraconazole affects other markers of prostate cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Memorial Sloan Kettering Cancer Center
• Treatments: Hydroxyitraconazole; Itraconazole

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.