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Darbepoetin alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Darbepoetin alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Darbepoetin alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer Clinical research trials and Darbepoetin alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Darbepoetin alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer. Darbepoetin alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Darbepoetin alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Darbepoetin alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Darbepoetin alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer  Darbepoetin alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer
Darbepoetin alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer
For Condition: plasma cell neoplasm,Leukemia,adult solid tumor,Lymphoma,Anemia
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Darbepoetin alfa and epoetin alfa may stimulate red blood cell production and treat anemia in patients who are receiving chemotherapy. It is not yet known whether darbepoetin alfa is more effective than epoetin alfa in treating patients with anemia. PURPOSE: Randomizedphase III trial to compare the effectiveness of darbepoetin alfa with that of epoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer.
Details: OBJECTIVES: Primary - Compare the efficacy of darbepoetin alfa vs epoetin alfa for anemia in patients with non-myeloid malignancies receiving chemotherapy. Secondary - Compare the safety of these drugs in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to screening hemoglobin concentration (less than 10.0 g/dL vs 10.0-11.0 g/dL) and type of concurrent chemotherapy (platinum-based vs non-platinum-based). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive darbepoetin alfa subcutaneously (SC) every other week for 12 weeks (i.e., on weeks 1, 3, 5, 7, 9, and 11). - Arm II: Patients receive epoetin alfa SC once weekly for 12 weeks. Patients are followed at 1 and 3 weeks . PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 6 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of a non-myeloid malignancy - The following diagnoses are excluded: - Acute myeloid leukemia - Chronic myeloid leukemia - Acute lymphoblastic leukemia - Hairy cell leukemia - Burkitt's lymphoma - Lymphoblastic lymphoma - Currently receiving or planning to receive at least 8 weeks of cyclic cytotoxic chemotherapy - Hemoglobin no greater than 11.0 g/dL - No other primary hematologic disorder that would cause anemia (e.g., sickle cell anemia) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - See Disease Characteristics Hepatic - Bilirubin less than 2 times upper limit of normal (ULN) Renal - Creatinine less than 2 times ULN Cardiovascular - No angina - No congestive heart failure - No New York Heart Association class III or IV heart disease - No hypertension - No cardiac arrhythmia - No other unstable or uncontrolled disease or condition that would affect cardiac function Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No known seizure disorder - No known sensitivity to study agents - No clinically significant inflammatory disease (e.g., rheumatoid arthritis or Crohn's disease) - No confirmed neutralizing antibodies to epoetin alfa - No other disorder that would preclude study compliance or giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy - More than 30 days since prior darbepoetin alfa or epoetin alfa - No other concurrent epoetin alfas Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - More than 30 days since prior participation in investigational device or drug trials - No prior randomization to this study - No other concurrent investigational agents or procedures
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnGlaspy, Principal Investigator, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095
United States
Recruiting John Glaspy 310-825-1274
Additional Information:
Study ID Numbers: CDR0000333213; UCLA-0306021,AMGEN-20030125
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070382
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2. Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer
3. Phase I Study of Intrathecal Topotecan
4. UCN-01 in Treating Patients With Advanced Cancer
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Darbepoetin alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer
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