An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Patient With Non-Small Cell Lung Cancer Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer, Anemia
Both
Non-Small Cell Lung Cancer, Anemia
Trial Information
An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Patient With Non-Small Cell Lung Cancer Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy
Inclusion Criteria:
- Subjects receiving multi-cycle chemotherapy for non-small cell lungcancer - Anemia due to chemotherapy (hgb less than or equal to 11.0 g/dL) - Expected to
receive greater than or equal to 8 additional weeks of chemotherapy as part of their
planned treatment - Karnofsky Performance Scale (KPS) greater than or equal to 50% -
Adequate renal function - Adequate liver function Exclusion Criteria: - Iron deficiency -
Unstable cardiac disease - Known positive test for human immunodeficiency virus (HIV)
infection
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Anemia correction
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
United States: Institutional Review Board
Study ID:
20020165
NCT ID:
NCT00120679
Start Date:
October 2002
Completion Date:
December 2003
Related Keywords:
- Non-Small Cell Lung Cancer
- Anemia
- non-small cell lung cancer
- darbepoetin alfa
- Amgen
- Anemia
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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