Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

This study has been terminated.
(closed due to futility)
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00524589
First received: August 31, 2007
Last updated: January 27, 2014
Last verified: January 2014

August 31, 2007
January 27, 2014
April 2006
July 2010   (final data collection date for primary outcome measure)
Objective Response (Complete or Partial Response) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Objective response (complete or partial response)
Complete list of historical versions of study NCT00524589 on ClinicalTrials.gov Archive Site
Expression of VDR and CYP24 in Peripheral Blood Mononuclear Cells as Assessed at Baseline and on Days 2 and 3 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Expression of VDR and CYP24 in peripheral blood mononuclear cells as assessed at baseline and on days 2 and 3
Not Provided
Not Provided
 
Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
Phase II Study of Weekly Intravenous 1,25 Dihydroxycholecelciferol (Calcitriol) + Dexamethasone in Androgen Independent Prostate Cancer

RATIONALE: Calcitriol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. Dexamethasone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with dexamethasone may be an effective treatment for prostate cancer that did not respond to hormone therapy .

PURPOSE: This phase II trial is studying how well giving calcitriol together with dexamethasone works in treating patients with prostate cancer that did not respond to hormone therapy.

OBJECTIVES:

  • To investigate the response rate in patients with androgen-independent prostate cancer treated with calcitriol and dexamethasone.
  • To evaluate the toxicity of high-dose calcitriol and dexamethasone in these patients.

OUTLINE: Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and on days 2 and 3 to assess VDR and CYP24 expression in peripheral blood mononuclear cells.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Dietary Supplement: calcitriol
    IV
  • Drug: dexamethasone
    Oral
  • Genetic: protein expression analysis
    Correlative Study
  • Other: laboratory biomarker analysis
    Correlative Study
Experimental: Dexamethasone and Calcitriol
Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.
Interventions:
  • Dietary Supplement: calcitriol
  • Drug: dexamethasone
  • Genetic: protein expression analysis
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
18
September 2010
July 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • History of androgen-independent prostate cancer

    • Evidence of rising PSA level (with or without new lesion by radiograph or physical examination), defined as follows:

      • PSA level > 5 ng/mL and clearly rising on 2 measurements taken ≥ 2 weeks apart after androgen deprivation therapy (i.e., orchiectomy or luteinizing hormone-releasing hormone [LHRH] analogue) and antiandrogen withdrawal, if appropriate
    • PSA rising before and on the first value taken at 4 or 6 weeks after antiandrogen cessation is considered disease progression
  • Measurable or evaluable disease as defined by any of the following:

    • Measurable or evaluable tumor masses by radiograph or physical examination
    • Evaluable PSA
  • Concurrent LHRH analogue or diethylstilbestrol (DES) for testicular androgen suppression required if no prior bilateral orchiectomy

    • Patients receiving other monotherapy for testicular androgen suppression must switch to a LHRH analogue or DES ≥ 14 days prior to study entry

PATIENT CHARACTERISTICS:

  • ECOG 0-2
  • Life expectancy ≥ 12 weeks
  • ANC ≥ 1,000/mm³
  • Platelet count ≥ 75,000/mm³
  • Hemoglobin > 8.9 g/dL (transfusion or erythropoietin support allowed)
  • Serum creatinine ≤ 1.8 mg/dL
  • AST ≤ 4 times upper limit of normal (ULN)
  • Total bilirubin ≤ 2.0 mg/dL
  • Serum corrected calcium < ULN
  • No history of nephrolithiasis within the past 5 years
  • No unstable, uncontrolled peptic ulcer disease, congestive heart failure, glaucoma, HIV, or diabetes

PRIOR CONCURRENT THERAPY:

  • At least 28 days since prior androgen deprivation therapy (≥ 42 days for bicalutamide)

    • A 28-day washout period is not required for patients who have previously progressed despite antiandrogen withdrawal and who have resumed antiandrogens without reduction of PSA
  • At least 14 days since prior radiotherapy
  • At least 28 days since prior strontium 89
  • At least 28 days since prior chemotherapy and/or investigational agents
  • No concurrent medications or supplements that contain additional calcium (e.g., Tums)
  • No concurrent radiotherapy for pain control or any other indication
  • Concurrent bisphosphonates allowed provided dose/regimen is stable
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00524589
CDR0000563197, RPCI I-65405
Yes
Roswell Park Cancer Institute
Roswell Park Cancer Institute
Not Provided
Principal Investigator: Donald L. Trump, MD Roswell Park Cancer Institute
Roswell Park Cancer Institute
January 2014

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