Spots Global Cancer Trial Database for Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy

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Trial Identification

Brief Title: Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy

Official Title: Calcitriol + Dexamethasone in Early, Recurrent Prostate Cancer Following Local Therapy, A Phase I/II Trial

Study ID: NCT00054522

Conditions

Prostate Cancer

Interventions

calcitriol

dexamethasone

Study Description

Brief Summary: RATIONALE: Calcitriol may help tumor cells develop into normal cells. Dexamethasone may increase the effectiveness of calcitriol by making tumor cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combining calcitriol with dexamethasone in treating patients with prostate cancer who have undergone surgery or radiation therapy.

Detailed Description: OBJECTIVES: * Determine whether calcitriol and dexamethasone can slow the rise in prostate-specific antigen (PSA) levels in patients with early, recurrent prostate cancer after prior radical prostatectomy or radiotherapy. * Determine the safety of this regimen in these patients. * Determine the utility of serum PSA in monitoring the therapeutic effect of calcitriol in these patients. OUTLINE: Patients are stratified according to prior therapy (radical prostatectomy vs radiotherapy). Patients receive oral calcitriol once daily on days 1-3 alone on week 1. Beginning on week 3, patients receive calcitriol as in week 1 and oral dexamethasone on days 0-4. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 56 patients (28 per stratum) will be accrued for this study.