Calcitriol and Zoledronate in Treating Patients With Progressive Prostate Cancer
RATIONALE: Calcitriol may help prostate cancer cells develop into normal cells. Zoledronate may delay or prevent the formation of bone metastases. Combining calcitriol and zoledronate may be an effective treatment for progressive prostate cancer.
PURPOSE: Phase I trial to study the effectiveness of combining calcitriol with zoledronate in treating patients who have progressive prostate cancer.
Dietary Supplement: calcitriol
Drug: zoledronic acid
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of 1,25 Dihydroxy-Vitamin D3 (Calcitriol) in Patients With Prostate Cancer|
|Study Start Date:||October 1999|
|Study Completion Date:||October 2004|
|Primary Completion Date:||October 2004 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose of calcitriol administered with zoledronate in patients with progressive prostate cancer.
- Assess the effects of this regimen on calcium homeostasis and bone turnover in this patient population.
- Assess changes in PSA in patients treated with this regimen.
- Determine other antitumor effects of this regimen in these patients.
OUTLINE: This is a dose-escalation study of calcitriol.
Patients receive oral calcitriol weekly for 3 consecutive days and zoledronate IV monthly. Treatment continues in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of calcitriol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004928
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Michael Morris, MD||Memorial Sloan Kettering Cancer Center|