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| Sponsor: | UPMC Cancer Centers |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00010231 |
Purpose
RATIONALE: Combining calcitriol with dexamethasone may increase the effectiveness of therapy by making cancer cells more sensitive to dexamethasone.
PURPOSE: Phase I trial to study the effectiveness of calcitriol combined with dexamethasone in treating patients who have prostate cancer that has not responded to previous hormone therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Dietary Supplement: calcitriol Drug: dexamethasone |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Study Of Oral, 1,25 Dihydroxycholecalciferol (Calcitriol) + Dexamethasone In Hormone-refractory Prostate Cancer |
| Study Start Date: | June 1999 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of calcitriol.
In the first stage of the study, cohorts of 3-6 patients receive escalating doses of oral calcitriol on days 1-3. Dose escalation continues until the maximum tolerated dose (MTD) is determined.
In the second stage, patients receive escalating doses of oral calcitriol on days 1-3 and a fixed dose of oral dexamethasone on days 0-4. Treatment continues weekly in the absence of disease progression or unacceptable toxicity. Dose escalation continues until the MTD is determined.
Six additional patients may receive calcitriol and dexamethasone at one dose level below the MTD determined in the second stage, to confirm the MTD.
The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 40 patients 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:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Pennsylvania | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213-3489 | |
| Study Chair: | Gurkamal S. Chatta, MD | UPMC Cancer Centers |
More Information
| Study ID Numbers: | CDR0000068457, PCI-99044, PCI-IRB-990606 |
| Study First Received: | February 2, 2001 |
| Last Updated: | July 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00010231 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate stage III prostate cancer stage IV prostate cancer 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 Dihydroxycholecalciferols 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 |