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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:
ClinicalTrials.gov Identifier:
NCT00524589
First Posted: September 3, 2007
Last Update Posted: November 20, 2017
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.
Information provided by (Responsible Party):
Roswell Park Cancer Institute
  Purpose

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.


Condition Intervention Phase
Prostate Cancer Dietary Supplement: calcitriol Drug: dexamethasone Genetic: protein expression analysis Other: laboratory biomarker analysis Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Weekly Intravenous 1,25 Dihydroxycholecelciferol (Calcitriol) + Dexamethasone in Androgen Independent Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Objective Response (Complete or Partial Response) [ Time Frame: 1 year ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.


Secondary Outcome Measures:
  • Corrected Serum Calcium Expression [ Time Frame: 1 year ]
    Number of patients with corrected serum calcium levels between 11 mg/dL and 12 mg/dL detected on 1 or more occasions.


Enrollment: 18
Study Start Date: April 2006
Study Completion Date: September 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Dietary Supplement: calcitriol
IV
Drug: dexamethasone
Oral
Genetic: protein expression analysis
Correlative Study
Other: laboratory biomarker analysis
Correlative Study

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00524589


Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Donald L. Trump, MD Roswell Park Cancer Institute
  More Information

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00524589     History of Changes
Other Study ID Numbers: CDR0000563197
RPCI I-65405 ( Other Identifier: Roswell Park Cancer Institute )
First Submitted: August 31, 2007
First Posted: September 3, 2007
Results First Submitted: January 27, 2014
Results First Posted: March 10, 2014
Last Update Posted: November 20, 2017
Last Verified: October 2017

Keywords provided by Roswell Park Cancer Institute:
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
Calcitriol
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents
Vitamins
Micronutrients