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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004928 |
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.
Condition | Intervention | Phase |
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Prostate Cancer |
Dietary Supplement: calcitriol Drug: zoledronic acid |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of 1,25 Dihydroxy-Vitamin D3 (Calcitriol) in Patients With Prostate Cancer |
Study Start Date: | October 1999 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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:
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 |
Study ID Numbers: | CDR0000067612, MSKCC-99073, NCI-H00-0048 |
Study First Received: | March 7, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004928 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer |
stage III prostate cancer stage IV prostate cancer recurrent prostate cancer |
Cholecalciferol Zoledronic acid Genital Neoplasms, Male Prostatic Diseases Bone Density Conservation Agents Trace Elements Urogenital Neoplasms Cardiovascular Agents Genital Diseases, Male Dihydroxycholecalciferols |
Recurrence Calcitriol Calcium, Dietary Vitamin D Vitamins Vasoconstrictor Agents Micronutrients Adenocarcinoma Prostatic Neoplasms |
Zoledronic acid Molecular Mechanisms of Pharmacological Action Genital Neoplasms, Male Prostatic Diseases Growth Substances Calcium Channel Agonists Physiological Effects of Drugs Bone Density Conservation Agents Urogenital Neoplasms Cardiovascular Agents Genital Diseases, Male |
Pharmacologic Actions Calcitriol Membrane Transport Modulators Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Vasoconstrictor Agents Micronutrients Prostatic Neoplasms |