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
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00524589     History of Changes
Other Study ID Numbers: CDR0000563197, RPCI I-65405
Study First Received: August 31, 2007
Results First Received: January 27, 2014
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
BB 1101
Calcitriol
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Bone Density Conservation Agents
Calcium Channel Agonists
Cardiovascular Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Growth Substances
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Membrane Transport Modulators
Micronutrients
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 30, 2014