Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
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Purpose
RATIONALE: Calcitriol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. Dexamethasone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with dexamethasone may be an effective treatment for prostate cancer that did not respond to hormone therapy .
PURPOSE: This phase II trial is studying how well giving calcitriol together with dexamethasone works in treating patients with prostate cancer that did not respond to hormone therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Dietary Supplement: calcitriol Drug: dexamethasone Genetic: protein expression analysis Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Weekly Intravenous 1,25 Dihydroxycholecelciferol (Calcitriol) + Dexamethasone in Androgen Independent Prostate Cancer |
- Objective response (complete or partial response) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Expression of VDR and CYP24 in peripheral blood mononuclear cells as assessed at baseline and on days 2 and 3 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 18 |
| Study Start Date: | April 2006 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
-
Dietary Supplement: calcitriol
OBJECTIVES:
- To investigate the response rate in patients with androgen-independent prostate cancer treated with calcitriol and dexamethasone.
- To evaluate the toxicity of high-dose calcitriol and dexamethasone in these patients.
OUTLINE: Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and on days 2 and 3 to assess VDR and CYP24 expression in peripheral blood mononuclear cells.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
History of androgen-independent prostate cancer
Evidence of rising PSA level (with or without new lesion by radiograph or physical examination), defined as follows:
- PSA level > 5 ng/mL and clearly rising on 2 measurements taken ≥ 2 weeks apart after androgen deprivation therapy (i.e., orchiectomy or luteinizing hormone-releasing hormone [LHRH] analogue) and antiandrogen withdrawal, if appropriate
- PSA rising before and on the first value taken at 4 or 6 weeks after antiandrogen cessation is considered disease progression
Measurable or evaluable disease as defined by any of the following:
- Measurable or evaluable tumor masses by radiograph or physical examination
- Evaluable PSA
Concurrent LHRH analogue or diethylstilbestrol (DES) for testicular androgen suppression required if no prior bilateral orchiectomy
- Patients receiving other monotherapy for testicular androgen suppression must switch to a LHRH analogue or DES ≥ 14 days prior to study entry
PATIENT CHARACTERISTICS:
- ECOG 0-2
- Life expectancy ≥ 12 weeks
- ANC ≥ 1,000/mm³
- Platelet count ≥ 75,000/mm³
- Hemoglobin > 8.9 g/dL (transfusion or erythropoietin support allowed)
- Serum creatinine ≤ 1.8 mg/dL
- AST ≤ 4 times upper limit of normal (ULN)
- Total bilirubin ≤ 2.0 mg/dL
- Serum corrected calcium < ULN
- No history of nephrolithiasis within the past 5 years
- No unstable, uncontrolled peptic ulcer disease, congestive heart failure, glaucoma, HIV, or diabetes
PRIOR CONCURRENT THERAPY:
At least 28 days since prior androgen deprivation therapy (≥ 42 days for bicalutamide)
- A 28-day washout period is not required for patients who have previously progressed despite antiandrogen withdrawal and who have resumed antiandrogens without reduction of PSA
- At least 14 days since prior radiotherapy
- At least 28 days since prior strontium 89
- At least 28 days since prior chemotherapy and/or investigational agents
- No concurrent medications or supplements that contain additional calcium (e.g., Tums)
- No concurrent radiotherapy for pain control or any other indication
- Concurrent bisphosphonates allowed provided dose/regimen is stable
Contacts and Locations| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Principal Investigator: | Donald L. Trump, MD | Roswell Park Cancer Institute |
More Information
No publications provided
| Responsible Party: | Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00524589 History of Changes |
| Other Study ID Numbers: | CDR0000563197, RPCI I-65405 |
| Study First Received: | August 31, 2007 |
| Last Updated: | September 23, 2011 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Roswell Park Cancer Institute:
|
recurrent prostate cancer |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 16, 2013