Prostate Cancer Clinical Trial
Official title:
Phase I Study Of Oral, 1,25 Dihydroxycholecalciferol (Calcitriol) + Dexamethasone In Hormone-refractory Prostate Cancer
RATIONALE: Combining calcitriol with dexamethasone may increase the effectiveness of therapy
by making cancer cells more sensitive to dexamethasone.
PURPOSE: Phase I trial to study the effectiveness of calcitriol combined with dexamethasone
in treating patients who have prostate cancer that has not responded to previous hormone
therapy.
OBJECTIVES:
- Determine the maximum tolerated dose of calcitriol administered alone and in
combination with dexamethasone in patients with hormone-refractory prostate cancer.
- Determine the pharmacokinetics of calcitriol with and without dexamethasone in these
patients.
OUTLINE: This is a dose-escalation study of calcitriol.
In the first stage of the study, cohorts of 3-6 patients receive escalating doses of oral
calcitriol on days 1-3. Dose escalation continues until the maximum tolerated dose (MTD) is
determined.
In the second stage, patients receive escalating doses of oral calcitriol on days 1-3 and a
fixed dose of oral dexamethasone on days 0-4. Treatment continues weekly in the absence of
disease progression or unacceptable toxicity. Dose escalation continues until the MTD is
determined.
Six additional patients may receive calcitriol and dexamethasone at one dose level below the
MTD determined in the second stage, to confirm the MTD.
The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience
dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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