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Epoetin alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Epoetin alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Epoetin alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy Clinical research trials and Epoetin alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy healthcare trials occur in a lot of 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 does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Epoetin alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy. Epoetin alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Epoetin alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy clinical trial. Test subjects typically receive the most effective healthcare possible for their Epoetin alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Epoetin alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy  Epoetin alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy
Epoetin alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy
For Condition: Lung Cancer,Leukemia,Lymphoma,Multiple Myeloma,Breast Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group
Synopsis: RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients with cancer who are receiving chemotherapy. It is not yet known whether epoetin alfa is more effective than a placebo in treating anemia in patients receiving chemotherapy. PURPOSE: Randomized double blinded phase III trial to compare the effectiveness of epoetin alfa with a placebo in treating anemia in cancer patients who are receiving chemotherapy.
Details: OBJECTIVES: I. Determine whether epoetin alfa treatment improves the quality of life in anemic patients who are undergoing chemotherapy for advanced malignancy. II. Determine whether epoetin alfa increases hemoglobin levels and decreases transfusion requirements in these patients. III. Validate or refute the use of an algorithm using pre- and posttreatment epoetin alfa, ferritin, and hemoglobin levels to predict 16 weeks response or no response to therapeutic doses of epoetin alfa as set forth by these patients. IV. Explore whether anemic patients receiving platinum-containing chemotherapy regimens experience less nephrotoxicity if they receive concurrent epoetin alfa compared to those who receive placebo. PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are stratified by primary malignant disease (lung vs breast vs other), life expectancy (4-6 months vs greater than 6 months), planned concurrent radiotherapy (yes vs no), and degree of anemia (mild or at least 9 g/dL vs severe or less than 9 g/dL). Patients receiving chemotherapy are randomized to receive epoetin alfa subcutaneously once a week for a maximum of 16 weeks (arm I) or placebo subcutaneously once a week for a maximum of 16 weeks (arm II). Quality of life is assessed at randomization and monthly throughout study. Patients are followed every 6 months for 1 year. PROJECTED ACCRUAL: There will be 300 patients (150 patients per arm) accrued into this study over 11 months.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Anemic: Hemoglobin in males less than 11.5 g/dL; hemoglobin in females less than 10.0 g/dL; No anemia secondary to B12, folic acid, or iron deficiency; No anemia secondary to gastrointestinal bleed or hemolysis; No anemia secondary to a primary or chemotherapy-induced myelodysplastic syndrome; No anemia secondary to acute lymphocytic leukemia - Histologically confirmed advanced malignancy; Lung; Breast; Other - Currently receiving myelosuppressive, cytotoxic chemotherapy for advanced cancer; No patients receiving adjuvant therapy for cancer that has been surgically removed --Prior/Concurrent Therapy-- - Biologic therapy: At least 1 year since prior epoetin alfa; At least 2 weeks since prior red blood cell transfusions; No concurrent peripheral blood stem cell or bone marrow transplantation - Chemotherapy: See Disease Characteristics - Endocrine therapy: Not specified - Radiotherapy: Concurrent radiotherapy allowed - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Life expectancy: At least 4 months - Hematopoietic: See Disease Characteristics - Hepatic: Not specified - Renal: Not specified - Cardiovascular: No uncontrolled hypertension (systolic at least 180, diastolic at least 100) - Other: Normal or elevated ferritin; No known hypersensitivity to epoetin alfa; Must be able to reliably take oral medication; Must be alert and mentally competent; Not pregnant or nursing
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasWitzig, Study Chair, North Central Cancer Treatment Group
CentraCare Clinic
St. Cloud, Minnesota, 56303
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Altru Health Systems
Grand Forks, North Dakota, 58201
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Howard University Cancer Center
Washington D.C., District of Columbia, 20060
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
Medcenter One Health System
Bismark, North Dakota, 58501
United States
Additional Information:
Study ID Numbers: CDR0000066673; NCCTG-979253,NCI-P98-0133
Study Start Date: December 1998
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003600
Other Lymphoma Studies:
1. Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer
2. Study of the Emotional Needs of Caregivers of Stem Cell Transplantation Patients
3. Itraconazole Compared With Fluconazole to Prevent Infections in Patients Undergoing Peripheral Stem Cell or Bone Marrow Transplantation
4. Raloxifene and Goserelin in Preventing Breast Cancer in Women With a Family History of Breast Cancer
5. Combination Chemotherapy (FLAC) Combined with Granulocyte-Macrophage Colony Stimulating Factor in Locally Advanced and Metastatic Breast Cancer
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Epoetin alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy
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