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| Sponsor: | Roswell Park Cancer Institute |
|---|---|
| Information provided by: | Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00054522 |
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 II |
| 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 |
| 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) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
No nephrolithiasis
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent medication known to affect systemic calcium metabolism, including any of the following:
Contacts and 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 | |
| Study Chair: | Donald L. Trump, MD | Roswell Park Cancer Institute |
More Information
| 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 |
|
adenocarcinoma of the prostate recurrent prostate cancer |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Calcitriol Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Vitamins Micronutrients Growth Substances |
Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents |