A Phase 1 interventional study of calcitriol and zoledronic acid in Prostate Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-19.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
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.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
Browse Prostatic Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,957 studies on the registry; 323 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 68 (52%) have results posted.
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DISEASE CHARACTERISTICS:
Histologically confirmed prior localized adenocarcinoma of the prostate that has undergone definitive radiation or surgery and demonstrates progression biochemically with all of the following:
Histologically confirmed androgen-independent adenocarcinoma of the prostate with all of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Metabolic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Calcitriol
Memorial Sloan Kettering Cancer Center →