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| Sponsor: | Roswell Park Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| 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: | Treatment, Open Label |
| Official Title: | Calcitriol + Dexamethasone in Early, Recurrent Prostate Cancer Following Local Therapy, A Phase I/II Trial |
| Study Start Date: | April 2002 |
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
| Study ID Numbers: | CDR0000270758, RPCI-RP-0203, PCI-00-034 |
| Study First Received: | February 5, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00054522 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate recurrent prostate cancer |
|
Anti-Inflammatory Agents Dexamethasone Prostatic Diseases Genital Neoplasms, Male Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Calcium Channel Agonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Urogenital Neoplasms Bone Density Conservation Agents Hormones Calcitriol Membrane Transport Modulators |
Neoplasms by Site Vitamins Therapeutic Uses Vasoconstrictor Agents Micronutrients Dexamethasone acetate Antineoplastic Agents, Hormonal Growth Substances Gastrointestinal Agents Cardiovascular Agents Genital Diseases, Male Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents |