Calcitriol and Zoledronate in Treating Patients With Progressive Prostate Cancer

June 18, 2013 updated by: Memorial Sloan Kettering Cancer Center

A Phase I Study of 1,25 Dihydroxy-Vitamin D3 (Calcitriol) in Patients With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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:

    • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

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

Hepatic:

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

Renal:

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

Cardiovascular:

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

Pulmonary:

  • No severe debilitating pulmonary disease

Metabolic:

  • 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)

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

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

Other:

  • No other concurrent cholecalciferol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1999

Primary Completion (Actual)

October 1, 2004

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

March 7, 2000

First Submitted That Met QC Criteria

May 13, 2003

First Posted (Estimate)

May 14, 2003

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99-073
  • CDR0000067612 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-H00-0048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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