Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy
NCT ID: NCT00111137
Last Updated: 2008-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
718 participants
INTERVENTIONAL
2003-02-28
2004-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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rHuEPO
rHuEPO
rHuEPO 40,000U QW for 4 weeks. Dose will be increased to 60,000U/week at week 5 if inadequate response through week 12.
Darbepoetin alfa
Darbepoetin alfa
4.5 mcg/kg QW for 4 weeks then Q3W starting at week 5 through week 11.
Interventions
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rHuEPO
rHuEPO 40,000U QW for 4 weeks. Dose will be increased to 60,000U/week at week 5 if inadequate response through week 12.
Darbepoetin alfa
4.5 mcg/kg QW for 4 weeks then Q3W starting at week 5 through week 11.
Eligibility Criteria
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Inclusion Criteria
* Anemia (hemoglobin \[hgb\] greater than or equal to 9.0g/dL and less than or equal to 11.0 g/dL) related to cancer and chemotherapy
* Karnofsky performance status of greater than or equal to 50%
* Serum bilirubin less than or equal to 2.5 times the upper limit of normal range and serum creatinine concentration of less than or equal to 2.0 mg/dL
Exclusion Criteria
* Hematologic disorder previously associated with anemia
* Active bleeding
* Iron deficiency
* Received erythropoietic therapy within 14 days prior to randomization
* Unstable cardiac disease
* Known positive human immunodeficiency virus antibody or hepatitis B surface antigen
* Known positive antibody response to any erythropoietic agent
* Currently enrolled in, or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving investigational agent(s) not approved for any indication
* Pregnant or breast feeding
* Red blood cell (RBC) transfusion within 4 weeks of screening
* Known hypersensitivity to any recombinant mammalian-derived product
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Amgen Inc.
Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20020139
Identifier Type: -
Identifier Source: org_study_id