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Calcitriol and Carboplatin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Calcitriol and Carboplatin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Calcitriol and Carboplatin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy Clinical research trials and Calcitriol and Carboplatin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Calcitriol and Carboplatin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy. Calcitriol and Carboplatin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Calcitriol and Carboplatin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Calcitriol and Carboplatin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Calcitriol and Carboplatin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy  Calcitriol and Carboplatin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
Calcitriol and Carboplatin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
For Condition: recurrent prostate cancer,stage 4 prostate cancer,adenocarcinoma of the prostate
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Oregon Health and Science University
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Calcitriol may help carboplatin kill more cancer cells by making tumor cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of carboplatin plus calcitriol in treating patients who have stage IV prostate cancer cancer that has not responded to hormone therapy.
Details: OBJECTIVES: I. Determine the response in patients with androgen-independent prostate cancer treated with calcitriol and carboplatin. II. Determine the palliative response in patients with cancer-related pain treated with this regimen. III. Determine the response in patients with bidimensionally measurable disease treated with this regimen. IV. Determine the duration of prostate-specific antigen, palliative, and measurable disease responses in patients treated with this regimen. V. Determine the survival of patients treated with this regimen. VI. Assess the quality of life of patients treated with this regimen. VII. Determine the qualitative and quantitative toxic effects of this regimen in these patients. PROTOCOL OUTLINE: Patients receive oral calcitriol on day 1 and carboplatin IV over 60 minutes on day 2. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression. Quality of life is assessed at baseline and then every 4 weeks until disease progression. Patients are followed every 4 weeks until disease progression and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed adenocarcinoma of the prostate; Stage IV - Evidence of progression despite standard hormonal management including antiandrogen withdrawal, defined as 1 of the following: Development of new metastatic lesions; Increase in cancer-related pain; A 50% rise in prostate-specific antigen (PSA) levels confirmed by 2 measurements at least 2 weeks apart - PSA at least 5 ng/mL - Testosterone less than 50 ng/mL --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No more than 1 type of prior chemotherapy for prostate cancer; No prior carboplatin or cisplatin for prostate cancer - Endocrine therapy: See Disease Characteristics; At least 4 weeks since prior flutamide or nilutamide (6 weeks for bicalutamide); Concurrent primary hormonal therapy allowed (e.g., gonadotropin-releasing hormone agonist or antagonist) - Radiotherapy: At least 1 month since prior radiotherapy; At least 2 months since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium - Surgery: Concurrent orchiectomy allowed - Other: At least 7 days since prior thiazide diuretic; At least 30 days since prior investigational therapy; No prior calcitriol for prostate cancer; No concurrent magnesium-containing antacids, bile-resin binders, or calcium supplements --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Life expectancy: At least 3 months - Hematopoietic: WBC at least 3,000/mm3; Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 2.0 mg/dL - Renal: Creatinine no greater than 1.3 mg/dL; Calcium no greater than 10.5 mg/dL; Phosphorus no greater than 4.2 mg/dL; No kidney stones within the past 5 years; No history of cancer-related hypercalcemia - Cardiovascular: No uncontrolled heart failure - Other: No other malignancy within the past 5 years except nonmelanoma skin cancer; No significant active medical illness that would preclude study; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TomaszBeer, Study Chair, Oregon Health and Science University
Oregon Cancer Institute
Portland, Oregon, 97201-3098
United States
Additional Information:
Study ID Numbers: CDR0000068720; NCI-G01-1963,OHSU-HOR-00059-L,OHSU-6218
Study Start Date: December 2000
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017576
Other Recurrent Prostate Cancer Studies:
1. Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
2. Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
3. DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer
4. Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy
5. Biological Therapy in Treating Patients With Prostate Cancer
Related Studies:
Other recurrent prostate cancer Clinical Trials
Other Oregon Clinical Trials
Other Portland Clinical Trials
Calcitriol and Carboplatin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
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