Prostate Cancer Clinical Trial
Official title:
Phase II Study of Calcitrol Enhanced Carboplatin in Hormone Refractory Prostate Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Calcitriol may help carboplatin kill more cancer cells by
making tumor cells more sensitive to the drug.
PURPOSE: Phase II trial to study the effectiveness of carboplatin plus calcitriol in
treating patients who have prostate cancer that has not responded to hormone therapy.
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
months thereafter.
PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study.
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