Phase I Study Of Oral, 1,25 Dihydroxycholecalciferol (Calcitriol) + Dexamethasone In Hormone-refractory Prostate Cancer
- 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
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
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
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
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.
Primary Purpose: Treatment
Gurkamal S. Chatta, MD
University of Pittsburgh
United States: Federal Government
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|