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Home > "E" Clinical Trials Conditions > Epoetin alfa in Treating Anemia in Patients With Solid Tumors  Epoetin alfa in Treating Anemia in Patients With Solid Tumors
Epoetin alfa in Treating Anemia in Patients With Solid Tumors
For Condition: Anemia,Leukemia,Lymphoma,plasma cell neoplasm,adult solid tumor
Status: Recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients with solid tumors. It is not yet known whether epoetin alfa given once a week is more effective than epoetin alfa given once every 3 weeks in treating anemia. PURPOSE: Randomizedphase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have solid tumors.
Details: OBJECTIVES: - Compare the effects of 2 different schedules of epoetin alfa on decreasing transfusion requirements in anemic patients with nonmyeloid cancer. - Compare the effects of these regimens on increasing hemoglobin levels in these patients. - Compare the effects of these regimens on overall quality of life (QOL) and anemia-specific components of QOL in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to concurrent chemotherapy or radiotherapy (yes vs no), concurrent platinum-based (cisplatin or carboplatin) chemotherapy (yes vs no), degree of anemia (mild [hemoglobin at least 9.0 g/dL] vs severe [hemoglobin less than 9.0 g/dL]), age (60 and under vs over 60), and type of neoplasm (plasma cell disorder [including multiple myeloma] or lymphoproliferative disorder [including non-Hodgkin's lymphoma and chronic lymphocytic leukemia] vs all other neoplasms). All patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Patients are then randomized to 1 of 2 treatment arms. - Arm I: Patients receive EPO SC once weekly for 18 weeks. - Arm II: Patients receive EPO SC on day 1 of weeks 4, 7, 10, 13, 16, and 19. Quality of life is assessed at randomization at then monthly during study treatment. Patients are followed every 6 months for 1 year. PROJECTED ACCRUAL: A total of 330 patients (165 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of a nonmyeloid cancer (excluding nonmelanoma skin cancer) - Anemia secondary to cancer or cancer treatment* - Hemoglobin less than 12 g/dL (males) - Hemoglobin less than 11 g/dL (females) NOTE: *Active anticancer therapy is not required for study enrollment - Anemia must not be secondary to any of the following: - B - , folic acid, or iron deficiency - Ferritin must be normal or elevated - Gastrointestinal bleeding or hemolysis - Primary or chemotherapy-induced myelodysplastic syndromes - No untreated CNS metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 6 months Hematopoietic - See Disease Characteristics Hepatic - Not specified Renal - Not specified Cardiovascular - No history of uncontrolled cardiac arrhythmias - No history of deep venous thrombosis within the past year (unless on anticoagulation) - No uncontrolled hypertension (systolic blood pressure at least 180 mm Hg and diastolic blood pressure at least 100 mm Hg) within the past year (unless on anticoagulation) Pulmonary - No history of pulmonary embolism within the past year (unless on anticoagulation) Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation - No known hypersensitivity to epoetin alfa, mammalian cell-derived products, or human albumin - No new onset of seizures within the past 3 months - No poorly controlled seizures - Able and willing to complete quality of life forms - Alert and mentally competent to give informed consent PRIOR CONCURRENT THERAPY: Biologic therapy - More than 6 months since prior epoetin alfa - More than 6 months since any prior investigational forms of epoetin alfa (e.g., gene-activated epoetin alfa or novel erythropoiesis-stimulating protein) - No concurrent peripheral blood stem cell transplantation - No concurrent bone marrow transplantation Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - More than 14 days since prior major surgery Other - More than 2 weeks since prior red blood cell transfusions
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidSteensma, Study Chair, Mayo Clinic Cancer Center
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting David Steensma 507-284-2511
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
Siouxland Hematology-Oncology *Recruiting*
Sioux City, Iowa, 51101-1733
United States
Recruiting Donald Wender 712-252-0088
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Edith Perez 904-953-0118
CCOP - Duluth *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting Daniel Nikcevich 218-786-3625
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
Altru Cancer Center *Recruiting*
Grand Forks, North Dakota, 58201
United States
Recruiting Todor Dentchev 701-780-6363
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Larry Ebbert 605-341-8704
CCOP - Oklahoma *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting Mark Olsen 918-499-2000
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
CCOP - Merit Care Hospital *Recruiting*
Fargo, North Dakota, 58122
United States
Recruiting Preston Steen 701-234-6161
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Additional Information:
Study ID Numbers: CDR0000288821; NCCTG-N02C2
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058331
Other Adult Solid Tumor Studies:
1. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Hematologic Cancer
2. A Trial of Carboxypeptidase-G2 (CPDG2) for the Management of Patients with Intrathecal Methotrexate Overdose
3. Bone Marrow and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
4. T-Cell Depletion in Unrelated Donor Marrow Transplantation
5. CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy
Related Studies:
Other adult solid tumor Clinical Trials
Other Iowa Clinical Trials
Other Sioux City Clinical Trials
Epoetin alfa in Treating Anemia in Patients With Solid Tumors
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