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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
calcitriol
dexamethasone
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute
  • Hillman Cancer Center at University of Pittsburgh Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 5, 2003
Last Updated
March 7, 2011
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00054522
Brief Title
Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy
Official Title
Calcitriol + Dexamethasone in Early, Recurrent Prostate Cancer Following Local Therapy, A Phase I/II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
calcitriol
Intervention Type
Drug
Intervention Name(s)
dexamethasone

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald L. Trump, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Hillman Cancer Center at University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

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

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