Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy
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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 2 |
| 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:
- Determine whether calcitriol and dexamethasone can slow the rise in prostate-specific antigen (PSA) levels in patients with early, recurrent prostate cancer after prior radical prostatectomy or radiotherapy.
- Determine the safety of this regimen in these patients.
- Determine the utility of serum PSA in monitoring the therapeutic effect of calcitriol in these patients.
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:
- Curatively treated with radical prostatectomy OR definitive radiotherapy
- No signs of clinical recurrence or dissemination of prostate cancer by digital rectal examination without tumor
- No local recurrence by CT scan or MRI of the pelvis
- No metastases by bone scan and chest x-ray NOTE: Prior Prostascint scans allowed regardless of results
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
- PSA at least 2 ng/mL after prostatectomy OR at least 4 ng/mL after prior radiotherapy
- Patients previously treated with radiotherapy must have a PSA clearly rising from lowest value within 6 months after completion of therapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- At least 12 months
Hematopoietic
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic
- Bilirubin no greater than upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2 times ULN
Renal
- Creatinine less than 1.8 mg/dL
- Phosphorus normal
- No hypercalcemia (albumin-corrected calcium greater than ULN)
No nephrolithiasis
- Single episode of renal lithiasis allowed provided episode occurred more than 5 years prior to study
Other
- Fertile patients must use effective double-barrier contraception for at least 1 week before, during, and for at least 2 weeks after study
- No symptomatic pancreatitis
- No uncontrolled diabetes
- No known or suspected inability to comply with study requirements (e.g., abuse of alcohol/drugs or psychotic states)
- Curatively treated condition associated with renal stones (e.g., hyperparathyroidism, bladder dysfunction, or obstructive uropathy) allowed provided patient has been free of stone formation for more than 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for prostate cancer
- At least 24 months since prior chemotherapy for other diseases
Endocrine therapy
- More than 6 months since prior hormonal therapy, including neoadjuvant or adjuvant androgen deprivation therapy (e.g., luteinizing hormone-releasing hormone analogue or antiandrogen)
- No prior androgen deprivation therapy of more than 8 months duration
- No prior hormonal therapy for prostate cancer more than 3 months after definitive local therapy
- No concurrent androgen therapy
Radiotherapy
- See Disease Characteristics
- More than 3 months since prior radiotherapy for locally recurrent prostate cancer
- No concurrent radiotherapy, including for pain control
Surgery
- See Disease Characteristics
Other
- More than 4 weeks since prior investigational drugs
No concurrent medication known to affect systemic calcium metabolism, including any of the following:
- More than 400 IU of cholecalciferol supplements
- More than 500 IU of vitamin A supplements
- Calcium supplements
- Fluoride
- Antiepileptics
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
Additional Information:
No publications provided
| 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 |
Keywords provided by Roswell Park Cancer Institute:
|
adenocarcinoma of the prostate 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 22, 2013