Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy
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|ClinicalTrials.gov Identifier: NCT00054522|
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : March 8, 2011
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 or disease||Intervention/treatment||Phase|
|Prostate Cancer||Dietary Supplement: calcitriol Drug: dexamethasone||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Calcitriol + Dexamethasone in Early, Recurrent Prostate Cancer Following Local Therapy, A Phase I/II Trial|
|Study Start Date :||April 2002|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||March 2006|
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): NCT00054522
|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|
|Study Chair:||Donald L. Trump, MD||Roswell Park Cancer Institute|