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Epoetin alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Epoetin alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Epoetin alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer Clinical research trials and Epoetin alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer health trials take place in a lot of of cities across the US. 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 / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Epoetin alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer. Epoetin alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Epoetin alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Epoetin alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Epoetin alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer  Epoetin alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
Epoetin alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
For Condition: Anemia,Fatigue,recurrent prostate cancer
Status: Not yet recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Epoetin alfa may stimulate red blood cell production and may help improve cancer-related anemia and fatigue. Steroid therapy with dexamethasone may increase the effectiveness of epoetin alfa. It is not yet known if epoetin alfa is more effective with or without dexamethasone in treating anemia-related fatigue in patients with prostate cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of epoetin alfa with or without dexamethasone in treating anemia-related fatigue in patients who have prostate cancer that is refractory to treatment with hormone therapy.
Details: OBJECTIVES: - Compare the effect of epoetin alfa with or without dexamethasone on the level of cancer-related fatigue measured by the FACIT fatigue subscale, in patients with hormone-refractory prostate cancer. - Compare the effect of these regimens on increasing hemoglobin levels in these patients. - Compare the effect of these regimens on palliation of other disease-related symptoms and on functional status and overall quality of life of these patients. - Compare the survival rate of these regimens in these patients. - Compare the toxicity profile of these regimens in these patients. - Determine the incidence of adrenal suppression in these patients after receiving dexamethasone therapy. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to usual fatigue severity on the Brief Fatigue Inventory numerical scale (3-6 vs 7-10) and hemoglobin level (8-10 g/dL vs 10.1-11.9 g/dL). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive epoetin alfa subcutaneously once a week. - Arm II: Patients receive epoetin alfa as in arm I and oral dexamethasone once a day. In both arms, treatment continues for 12 weeks in the absence of unacceptable toxicity. Quality of life and fatigue are assessed at baseline and then at 4, 8, and 12 weeks. Patients are followed for 3 years. PROJECTED ACCRUAL: A total of 282 patients (141 per treatment arm) will be accrued for this study within approximately 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed prostate cancer - Hormone-refractory disease as evidenced by progression on bone scan or CT scan with a rising prostate-specific antigen - Prior bilateral orchiectomy OR other primary hormonal therapy (e.g., estrogen therapy or luteinizing hormone-releasing hormone analog [LHRH] and flutamide) with evidence of treatment failure - Concurrent continual LHRH agonist therapy (e.g., depot leuprolide or goserelin) required for patients who have not undergone bilateral orchiectomy - Must have anemia with hemoglobin 8 g/dL and < 12 g/dL within the past 14 days - Must be iron replete (i.e., ferritin > 50 ng/mL) within the past 30 days - Presence of fatigue with usual fatigue severity 3on the 0-10 numerical scale of the Brief Fatigue Inventory within the past 14 days PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-3 Life expectancy - Not specified Hematopoietic - See Disease Characteristics - No disseminated intravascular coagulation - No autoimmune hemolytic anemia Hepatic - AST and ALT 2 times upper limit of normal - No prior hemochromatosis or iron intolerance Renal - Creatinine < 2.5 mg/dL Cardiovascular - Adequate blood pressure (i.e., systolic blood pressure < 140 mm Hg and diastolic blood pressure < 90 mm Hg) (treated or untreated) - No history of thromboembolic events - No unstable angina - No poorly controlled cardiac disease Other - Fertile patients must use effective contraception - Able to read, understand, and answer questions on the symptom and quality of life study instruments - No ongoing chronic hemorrhage (e.g., gross hematuria due to advanced prostate cancer)* NOTE: *Microscopic hematuria allowed - No acute or subacute illness that may require transfusion - No gastrointestinal bleeding - No active systemic infection - No known or suspected hypersensitivity to human albumin - No known or suspected hypersensitivity to mammalian cell-derived products - No uncontrolled diabetes PRIOR CONCURRENT THERAPY: Biologic therapy - More than 30 days since prior epoetin alfa Chemotherapy - More than 21 days since prior chemotherapy - No more than 2 different types of prior chemotherapy regimens for hormone-refractory prostate cancer Endocrine therapy - See Disease Characteristics - More than 30 days since prior corticosteroids for hormone-refractory prostate cancer - Episodic use of low-dose steroids for other causes is allowed Radiotherapy - More than 21 days since prior radiotherapy - Concurrent radiotherapy allowed Surgery - See Disease Characteristics Other - More than 8 days since prior blood transfusion - Concurrent blood transfusions allowed - No concurrent oral or intravenous antibiotics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ShirleyHwang, Study Chair, Veterans Affairs Medical Center - East Orange
Additional Information:
Study ID Numbers: CDR0000301881; ECOG-E1Z01
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060398
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1. Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer
2. Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
3. Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss
4. Epoetin Alfa in Treating Chemotherapy-Related Anemia in Women With Stage I, Stage II, or Stage III Breast Cancer
5. Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors
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Epoetin alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
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