Phase II Study of Calcitrol Enhanced Carboplatin in Hormone Refractory Prostate Cancer
OBJECTIVES: I. Determine the response in patients with androgen-independent prostate cancer
treated with calcitriol and carboplatin. II. Determine the palliative response in patients
with cancer-related pain treated with this regimen. III. Determine the response in patients
with bidimensionally measurable disease treated with this regimen. IV. Determine the
duration of prostate-specific antigen, palliative, and measurable disease responses in
patients treated with this regimen. V. Determine the survival of patients treated with this
regimen. VI. Assess the quality of life of patients treated with this regimen. VII.
Determine the qualitative and quantitative toxic effects of this regimen in these patients.
OUTLINE: Patients receive oral calcitriol on day 1 and carboplatin IV over 60 minutes on day
2. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease
progression. Quality of life is assessed at baseline and then every 4 weeks until disease
progression. Patients are followed every 4 weeks until disease progression and then every 3
PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA response rate defined as 50% decrease from baseline, confirmed on a second measurement 4 weeks later
Tomasz M. Beer, MD
OHSU Knight Cancer Institute
United States: Federal Government
|OHSU Knight Cancer Institute||Portland, Oregon 97239|