A Phase I/II Study of Oral Calcitriol in Combination with Ketoconazole in Androgen Independent Prostate Cancer
Title A Phase I/II Study of Oral Calcitriol in Combination with Ketoconazole in Androgen Independent Prostate Cancer
Contact AWOLF
Principal Investigator Donald Trump, MD FACP
Study Number 68905
Phase2
Summary This study is being done to determine the frequency with which objective reductions in the manifestation of prostate cancer occur with the therapy of calcitriol in combination with the drug ketconazole and the drug hydrocortisone.
Eligibility
- Histologically or cytologically confirmed adenocarcinoma consistent clinically and by microscopy with prostate cancer.
- Measurable or evaluable disease (PSA elevation will constitute evaluable disease)
- 2 regimens of cytotoxic chemotherapy prior to study entry
- Patients must have prostate cancer that is advanced or recurrent and for which standard curative or reliable palliative therapies do not exist or are no longer effective.
- Eastern Clinical Oncology Group performance status < or = 2 (Karnofsky > or = 60%)
- Life expectancy > 3 months
- Patients must have normal organ and marrow functions
- Patients should be able to receive oral medications
