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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00039247 |
RATIONALE: Darbepoetin alfa may stimulate red blood cell production and may be effective in treating anemia in patients who are receiving chemotherapy.
PURPOSE: Randomized phase II trial to determine the effectiveness of darbepoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer.
Condition | Intervention | Phase |
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Anemia Unspecified Adult Solid Tumor, Protocol Specific |
Biological: darbepoetin alfa |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Active Control |
Official Title: | A Randomized, Open-Label, Dose-Timing Study Of Darbepoetin Alfa Administered Once Every 3 Weeks (Q3W) by Subcutaneous (SC) Injection For Treatment Of Anemia In Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to screening hemoglobin (less than 10.0 g/dL vs 10.0-11.0 g/dL) and participating center. Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment repeats every 3 weeks for up to 5 courses in the absence of unacceptable toxicity or treatment failure.
PROJECTED ACCRUAL: A total of 80 patients (40 per arm) will be accrued for this study within 8 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Cancer- or chemotherapy-related anemia
Currently receiving chemotherapy on a 3-week course schedule
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study ID Numbers: | CDR0000069366, UCLA-0111006, AMGEN-20010162, NCI-G02-2071 |
Study First Received: | June 6, 2002 |
Last Updated: | May 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00039247 History of Changes |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific anemia |
Hematinics Hematologic Diseases Darbepoetin alfa Anemia |
Hematinics Hematologic Diseases Therapeutic Uses Hematologic Agents |
Darbepoetin alfa Anemia Pharmacologic Actions |