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Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy Clinical research trials and Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy. Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy clinical trial. Subjects frequently obtain the most expert healthcare possible for their Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy  Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy
Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy
For Condition: adenocarcinoma of the prostate,recurrent prostate cancer
Status: Recruiting
Sponsor(s): Roswell Park Cancer Institute , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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 2, patients receive calcitriol as in week 1 and oral dexamethasone on days 1-4. 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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 - WBC at least 3,000/mm^3 - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DonaldTrump, Study Chair, Roswell Park Cancer Institute
Roswell Park Cancer Institute *Recruiting*
Buffalo, New York, 14263-0001
United States
Recruiting Donald Trump 716-845-3499
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15232
United States
Recruiting Joel Nelson 412-605-3013
Additional Information:
Study ID Numbers: CDR0000270758; RPCI-RP-0203,PCI-00-034
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054522
Other Adenocarcinoma Of The Prostate Studies:
1. Computer Planned Radiation Therapy in Treating Patients With Prostate Cancer
2. BMS-275291 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
3. Calcitriol and Carboplatin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
4. Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer
5. SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other New York Clinical Trials
Other Buffalo Clinical Trials
Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy
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