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| ID | Type | Description | Link |
|---|---|---|---|
| RPCI-RP-0203 |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calcitriol | Dietary Supplement | |||
| dexamethasone | Drug |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate meeting all of the following criteria:
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
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Creatinine less than 1.8 mg/dL
Phosphorus normal
No hypercalcemia (albumin-corrected calcium greater than ULN)
No nephrolithiasis
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
More than 4 weeks since prior investigational drugs
No concurrent medication known to affect systemic calcium metabolism, including any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Donald L. Trump, MD | Roswell Park Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States | ||
| Hillman Cancer Center at University of Pittsburgh Cancer Institute |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002117 | Calcitriol |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
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| Pittsburgh |
| Pennsylvania |
| 15232 |
| United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002776 |
| Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013259 | Steroids, Fluorinated |