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Calcitriol and Zoledronate in Treating Patients With Progressive Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004928
Recruitment Status : Completed
First Posted : May 14, 2003
Last Update Posted : June 19, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: calcitriol Drug: zoledronic acid Phase 1

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
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
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed prior localized adenocarcinoma of the prostate that has undergone definitive radiation or surgery and demonstrates progression biochemically with all of the following:

    • Baseline PSA at least 4 ng/mL
    • At least a 50% increase in PSA over at least 3 determinations taken at more than 2 week intervals
    • No radiographically evident disease
    • Neoadjuvant hormonal therapy prior to radical prostatectomy or radiotherapy allowed
    • Treatment in an intermittent approach allowed if off therapy for at least 12 weeks OR
  • Histologically confirmed androgen-independent adenocarcinoma of the prostate with all of the following:

    • Progression on primary hormonal treatment (e.g., orchiectomy, estrogen therapy, gonadotropin-releasing hormone analog with or without an antiandrogen) with either new osseous lesions in bone, a greater than 25% increase in bidimensionally measurable tumor mass, or rising PSA values (rising PSA on any 3 determinations taken at at least weekly intervals, to greater than 50% above baseline PSA) despite castrate levels of testosterone (no greater than 30 ng/mL)
    • If receiving antiandrogen as part of primary hormonal therapy, must meet criteria above for progression after discontinuation of antiandrogen
    • No change in hormonal therapy (including prednisone or dexamethasone) within the past 2 weeks
    • If no prior surgical orchiectomy, must continue on medical therapies to maintain castrate levels of testosterone
    • Prior chemotherapy, palliative radiotherapy, or radioisotope treatment allowed



  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 3 months


  • WBC at least 3,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin less than 2.0 mg/dL OR
  • SGOT less than 3 times upper limit of normal


  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min
  • No history of nephrolithiasis
  • Must have 2 functioning kidneys


  • No New York Heart Association class III or IV heart disease


  • No severe debilitating pulmonary disease


  • No pre-existing endocrine or metabolic disorders that impact calcium regulatory axis including hypercalcemia (ionized serum calcium greater than 5.3 mg/dL or total calcium greater than 10.5 mg/dL) or hypercalciuria (greater than 300 mg urinary calcium/24 hours)


  • No active secondary malignancy except nonmelanoma skin cancer
  • Must maintain low calcium diet (less than 800 mg calcium daily)
  • No uncontrolled serious active infection
  • No history of malabsorption disorders
  • No history of inflammatory bowel disease


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy and recovered
  • No concurrent chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • Recovered from prior endocrine therapy


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy to sole measurable lesion


  • See Disease Characteristics
  • Recovered from prior surgery
  • No concurrent surgery to sole measurable lesion


  • No other concurrent cholecalciferol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004928

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: Michael Morris, MD Memorial Sloan Kettering Cancer Center

Layout table for additonal information Identifier: NCT00004928    
Other Study ID Numbers: 99-073
CDR0000067612 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 14, 2003    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Growth Substances