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A Randomized Phase II Study of High Dose Ketoconazole Plus Alendronate Versus High Dose Ketoconazole in Patients with Androgen Independent Metastatic Prostate Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on A Randomized Phase II Study of High Dose Ketoconazole Plus Alendronate Versus High Dose Ketoconazole in Patients with Androgen Independent Metastatic Prostate Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Randomized Phase II Study of High Dose Ketoconazole Plus Alendronate Versus High Dose Ketoconazole in Patients with Androgen Independent Metastatic Prostate Cancer Clinical research trials and A Randomized Phase II Study of High Dose Ketoconazole Plus Alendronate Versus High Dose Ketoconazole in Patients with Androgen Independent Metastatic Prostate Cancer healthcare trials happen in a lot of of localities across 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 generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as A Randomized Phase II Study of High Dose Ketoconazole Plus Alendronate Versus High Dose Ketoconazole in Patients with Androgen Independent Metastatic Prostate Cancer. A Randomized Phase II Study of High Dose Ketoconazole Plus Alendronate Versus High Dose Ketoconazole in Patients with Androgen Independent Metastatic Prostate Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Randomized Phase II Study of High Dose Ketoconazole Plus Alendronate Versus High Dose Ketoconazole in Patients with Androgen Independent Metastatic Prostate Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their A Randomized Phase II Study of High Dose Ketoconazole Plus Alendronate Versus High Dose Ketoconazole in Patients with Androgen Independent Metastatic Prostate Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Randomized Phase II Study of High Dose Ketoconazole Plus Alendronate Versus High Dose Ketoconazole in Patients with Androgen Independent Metastatic Prostate Cancer  A Randomized Phase II Study of High Dose Ketoconazole Plus Alendronate Versus High Dose Ketoconazole in Patients with Androgen Independent Metastatic Prostate Cancer
A Randomized Phase II Study of High Dose Ketoconazole Plus Alendronate Versus High Dose Ketoconazole in Patients with Androgen Independent Metastatic Prostate Cancer
For Condition: Neoplasm Metastasis,Prostatic Neoplasm
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This is an open-label, randomized, phase II study of high-dose ketoconazole plus alendronate versus high dose ketoconazole in patients with androgen-independent metastatic prostate cancer. Following pharmacokinetic assessment, ketoconazole will be initiated at a dose of 400 mg three times per day, plus 30 mg of hydrocortisone (20 mg in the morning and 10 mg in the evening), plus or minus alendronate 40 mg orally every morning. Each patient will be evaluated every 4 weeks for the duration of the study. Radiographic studies will be repeated every 2 months.
Details: This is an open-label, randomized, phase II study of high-dose ketoconazole plus alendronate versus high dose ketoconazole in patients with androgen-independent metastatic prostate cancer. Following pharmacokinetic assessment, ketoconazole will be initiated at a dose of 400 mg three times per day, plus 30 mg of hydrocortisone (20 mg in the morning and 10 mg in the evening), plus or minus alendronate 40 mg orally every morning. Each patient will be evaluated every 4 weeks for the duration of the study. Radiographic studies will be repeated every 2 months.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: INCLUSION CRITERIA: Patients must have androgen independent adenocarcinoma of the prostate with at least one bone lesion that is felt to be associated with metastatic disease. Patients who have undergone a radical prostatectomy or received radiation therapy to the prostate will be eligible. Patients must have a histopathological documentation of prostate cancer confirmed in the Pathology Department of the Clinical Center at the National Institutes of Health or the National Naval Medical Center prior to starting this study. If the tissue pathology slides are not available and the clinical course is consistent with prostate cancer and there is a prior pathological documentation of prostate cancer (we must have a copy of that pathology report from an outside pathologist), then the patient is still eligible for treatment on this protocol. Patients must have clinically progressive androgen-independent prostate cancer documented for at least 1 month prior to entry. Refractory disease must be demonstrated after the withdrawal of flutamide, nilutamide, bicalutamide or any other antiandrogen (i.e., ketoconazole, aminoglutethimide, bicalutamide, megace). Progression must be documented by at least one of the following parameters: two consecutively rising PSA levels, separated by at least one week, with at least one measurement that is 50% above the nadir reached after the last therapeutic maneuver (as long as the last measurement is 10 ng/ml or greater); and/or at least one new metastatic deposit on Tc-99 bone scintigraphy; and/or progression of soft-tissue metastases as measured by appropriate modalities (i.e., imaging, palpation) such as development of new area of malignant disease (measurable or evaluable) or increase in any area of measurable disease by more than 25 percent using the sum of the products of the greatest perpendicular diameters of all measured lesions. Patients with PSA negative disease (defined as PSA less than 10 ng/mL), must also have positive CT scan soft tissue disease that can be used for disease staging, bone scan or some other form of documentable disease progression (i.e., rising CEA, PAP). Patients who have not undergone surgical castration must continue treatment with a LHRH agonist. If for some reason the LHRH agonist has been discontinued prior to entry on the study, then it should be reinstituted and disease progression must be documented. Patients must have a life expectancy of more than 3 months. Patients must have a performance status of 0 to 2 according to the ECOG criteria. Patients with local complications which require urgent local medical therapy are not eligible, but may become so after resolution of the acute problem (i.e. severe bone pain, spinal cord compression, urinary flow obstruction, etc.). Radiation therapy, hormonal therapy (with the exception of patients receiving LHRH agonist and those agents should be continued for the duration of this study), and any other forms of anticancer therapy must have been stopped at least 4 weeks prior to enrollment. Patients must have recovered from any toxicity related to prior therapy, including surgery. Hematological eligibility parameters (within 2 weeks of starting therapy): granulocyte count greater than or equal to 1,000/mm3, hemoglobin greater than or equal to 8.0 g/dL (pre-treatment transfusion is allowed, provided the hemoglobin is maintained for more than 30 days without additional transfusions and/or an active source of bleeding is identified and treated), and platelet count is greater than or equal to 75,000/mm3. Biomedical eligibility parameters (within 2 weeks of starting therapy): 1.) Acute care panel (electrolytes, BUN) and urinalysis should be considered normal for each patient in the judgement of the clinic attending (blood glucose is excluded from this evaluation); no gross abnormalities should be present; 2.) if the creatinine is greater than 1.5 mg/dL or proteinuria (greater than 2 plus) is present, obtain a 24 hour urine collection; creatinine clearance must be greater than 40 mL/min and proteinuria less than 500 mg/day (except for those patients with stents in place in which proteinuria will not be an exclusion); 3.) hepatic function: bilirubin (total) is less than or equal to 1.2 mg/dL; ALT less than 2.5 x upper limit of normal; AST less than 2.5 x normal. Hormonal profile for patients with prostate cancer: patients must have a serum testosterone in the range expected for castrated males. Patients must not have other active malignancies (within the past two years, with the exception of non-melanoma skin cancers or carcinoma in situ of the bladder) or life threatening illnesses, including untreated infection. Ureteral stents, or foley catheter, although often colonized, are not a contraindication to enrollment. Patients must not have a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment), New York Heart Assoc. class II-IV congestive heart failure, chronic obstructive lung disease requiring oxygen therapy, uncontrolled seizure activity. Patients must be able to understand and sign an informed consent form. Patients must be willing to travel from their home to the NIH for follow-up visits. Patients must be greater than or equal to 18 years of age. EXCLUSION CRITERIA: Patients with brain metastases or primary CNS malignancies. Patients with a history of seizures within the past 10 years or using phenytoin. Patients who have received transfusions with strontium and/or samarium. Patients must not have active infections, including positive serology for HIV. Patients that have previously received ketoconazole for their cancer. Patients on theophylline. Patients who are receiving cisapride,alprazolam, astemizole, atorvastatin, cerivastatin, dofetilide, erythromycin, isoniazid, loratadine, lovastatin, pimozide, rifampin, simvastatin, sirolimus, or triazolam. Patients on suppressive antibiotic therapy will be evaluated on a case-by-case basis. Concomitant administration of drugs which decrease gastric acid output or increase gastric pH (e.g., antacids, cimetidine, ranitidine, antimuscarinics) may decrease absorption of ketoconazole and will be prohibited. Patients who require terfenadine or midazolam. Patients requiring warfarin.
Total Enrollment: 72
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990052; 99-C-0052
Study Start Date: February 26, 1999
Record last reviewed: January 28, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001802
Other Neoplasm Metastasis Studies:
1. Genetic Analysis of Hereditary Prostate Cancer
2. A Randomized Phase II Study of High Dose Ketoconazole Plus Alendronate Versus High Dose Ketoconazole in Patients with Androgen Independent Metastatic Prostate Cancer
3. A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma
4. A Randomized Phase II Study of Oral Thalidomide in Patients with Hormone-Refractory Prostate Cancer
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A Randomized Phase II Study of High Dose Ketoconazole Plus Alendronate Versus High Dose Ketoconazole in Patients with Androgen Independent Metastatic Prostate Cancer
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