Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy

This study has been completed.
Sponsor:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00054522
First received: February 5, 2003
Last updated: March 7, 2011
Last verified: March 2011
  Purpose

RATIONALE: Calcitriol may help tumor cells develop into normal cells. Dexamethasone may increase the effectiveness of calcitriol by making tumor cells more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of combining calcitriol with dexamethasone in treating patients with prostate cancer who have undergone surgery or radiation therapy.


Condition Intervention Phase
Prostate Cancer
Dietary Supplement: calcitriol
Drug: dexamethasone
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Calcitriol + Dexamethasone in Early, Recurrent Prostate Cancer Following Local Therapy, A Phase I/II Trial

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Enrollment: 15
Study Start Date: April 2002
Study Completion Date: March 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine whether calcitriol and dexamethasone can slow the rise in prostate-specific antigen (PSA) levels in patients with early, recurrent prostate cancer after prior radical prostatectomy or radiotherapy.
  • Determine the safety of this regimen in these patients.
  • Determine the utility of serum PSA in monitoring the therapeutic effect of calcitriol in these patients.

OUTLINE: Patients are stratified according to prior therapy (radical prostatectomy vs radiotherapy).

Patients receive oral calcitriol once daily on days 1-3 alone on week 1. Beginning on week 3, patients receive calcitriol as in week 1 and oral dexamethasone on days 0-4. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 56 patients (28 per stratum) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate meeting all of the following criteria:

    • Curatively treated with radical prostatectomy OR definitive radiotherapy
    • No signs of clinical recurrence or dissemination of prostate cancer by digital rectal examination without tumor
    • No local recurrence by CT scan or MRI of the pelvis
    • No metastases by bone scan and chest x-ray NOTE: Prior Prostascint scans allowed regardless of results
  • At least 3 prostate-specific antigen (PSA) measurements obtained over at least 90 days after radical prostatectomy on post-radiotherapy PSA nadir must be available

    • PSA at least 2 ng/mL after prostatectomy OR at least 4 ng/mL after prior radiotherapy
    • Patients previously treated with radiotherapy must have a PSA clearly rising from lowest value within 6 months after completion of therapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 12 months

Hematopoietic

  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic

  • Bilirubin no greater than upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2 times ULN

Renal

  • Creatinine less than 1.8 mg/dL
  • Phosphorus normal
  • No hypercalcemia (albumin-corrected calcium greater than ULN)
  • No nephrolithiasis

    • Single episode of renal lithiasis allowed provided episode occurred more than 5 years prior to study

Other

  • Fertile patients must use effective double-barrier contraception for at least 1 week before, during, and for at least 2 weeks after study
  • No symptomatic pancreatitis
  • No uncontrolled diabetes
  • No known or suspected inability to comply with study requirements (e.g., abuse of alcohol/drugs or psychotic states)
  • Curatively treated condition associated with renal stones (e.g., hyperparathyroidism, bladder dysfunction, or obstructive uropathy) allowed provided patient has been free of stone formation for more than 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for prostate cancer
  • At least 24 months since prior chemotherapy for other diseases

Endocrine therapy

  • More than 6 months since prior hormonal therapy, including neoadjuvant or adjuvant androgen deprivation therapy (e.g., luteinizing hormone-releasing hormone analogue or antiandrogen)
  • No prior androgen deprivation therapy of more than 8 months duration
  • No prior hormonal therapy for prostate cancer more than 3 months after definitive local therapy
  • No concurrent androgen therapy

Radiotherapy

  • See Disease Characteristics
  • More than 3 months since prior radiotherapy for locally recurrent prostate cancer
  • No concurrent radiotherapy, including for pain control

Surgery

  • See Disease Characteristics

Other

  • More than 4 weeks since prior investigational drugs
  • No concurrent medication known to affect systemic calcium metabolism, including any of the following:

    • More than 400 IU of cholecalciferol supplements
    • More than 500 IU of vitamin A supplements
    • Calcium supplements
    • Fluoride
    • Antiepileptics
  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: NCT00054522

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Study Chair: Donald L. Trump, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Donald Trump, MD, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00054522     History of Changes
Other Study ID Numbers: CDR0000270758, RPCI-RP-0203
Study First Received: February 5, 2003
Last Updated: March 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
adenocarcinoma of the prostate
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 22, 2014