Calcitriol Plus Dexamethasone in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Pittsburgh Identifier:
First received: February 2, 2001
Last updated: March 27, 2015
Last verified: March 2015

February 2, 2001
March 27, 2015
June 1999
August 2002   (final data collection date for primary outcome measure)
  • MTD of calcitriol (oral) administered for 3 days (Monday, Tuesday, Wednesday -MTW) weekly in men with hormone-refractory prostate cancer [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • MTD of calcitriol (oral, MTW weekly + dexamethasone (oral, Sunday, Monday, Tuesday, Wednesday - SMTW) in men with hormone refractory prostate cancer [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00010231 on Archive Site
  • whether dexamethasone permits the administration of calcitriol without the development of hypercalcemia in patients who developed hypercalcemia while receiving calcitriol alone [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • pharmacokinetics of calcitriol when given as a single agent and following 3 days of dexamethasone [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • effects of calcitriol +/- dexamethasone on serum PTH, urinary calcium and MAPK activity and VDR expression in serum, urine and PBMs , respectively, in this patient population [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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Calcitriol Plus Dexamethasone in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Phase I Study Of Oral, 1,25 Dihydroxycholecalciferol (Calcitriol) + Dexamethasone In Hormone-refractory Prostate Cancer

RATIONALE: Combining calcitriol with dexamethasone may increase the effectiveness of therapy by making cancer cells more sensitive to dexamethasone.

PURPOSE: Phase I trial to study the effectiveness of calcitriol combined with dexamethasone in treating patients who have prostate cancer that has not responded to previous hormone therapy.


  • Determine the maximum tolerated dose of calcitriol administered alone and in combination with dexamethasone in patients with hormone-refractory prostate cancer.
  • Determine the pharmacokinetics of calcitriol with and without dexamethasone in these patients.

OUTLINE: This is a dose-escalation study of calcitriol.

In the first stage of the study, cohorts of 3-6 patients receive escalating doses of oral calcitriol on days 1-3. Dose escalation continues until the maximum tolerated dose (MTD) is determined.

In the second stage, patients receive escalating doses of oral calcitriol on days 1-3 and a fixed dose of oral dexamethasone on days 0-4. Treatment continues weekly in the absence of disease progression or unacceptable toxicity. Dose escalation continues until the MTD is determined.

Six additional patients may receive calcitriol and dexamethasone at one dose level below the MTD determined in the second stage, to confirm the MTD.

The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.

Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Dietary Supplement: calcitriol
  • Drug: dexamethasone
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2002
August 2002   (final data collection date for primary outcome measure)


  • Histologically confirmed adenocarcinoma of the prostate with progressing regional or metastatic disease despite primary hormonal therapy (bilateral orchiectomy, estrogen, or luteinizing hormone-releasing hormone (LHRH) therapy with or without simultaneous antiandrogen)
  • Documented new lesions or rising PSA (at least 50% increase on 3 measurements more than 2 weeks apart) after prior antiandrogen or progestational agent, or other hormonal agent cessation



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • WBC greater than 3,500/mm^3
  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3


  • Bilirubin less than 2.0 mg/dL
  • SGOT less than 4 times upper limit of normal


  • Creatinine no greater than 1.8 mg/dL


  • No uncontrolled diabetes mellitus
  • Fertile patients must use effective double barrier contraception for at least 1 week before, during, and at least 2 weeks after study participation


Biologic therapy:

  • Concurrent epoetin alfa for anemia allowed


  • Not specified

Endocrine therapy:

  • See Disease Characteristics
  • At least 28 days since prior antiandrogens or progestational agents
  • Concurrent testicular androgen suppression with an LHRH analog (leuprolide or goserelin) allowed in non-orchidectomized patients


  • No concurrent radiotherapy


  • Not specified


  • No concurrent bisphosphonates
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
PCI-99044, CDR0000068457, PCI-IRB-990606
University of Pittsburgh
University of Pittsburgh
National Cancer Institute (NCI)
Study Chair: Gurkamal S. Chatta, MD University of Pittsburgh
University of Pittsburgh
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP