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Treatment for Patients With Non-Small Cell Lung Cancer Who Developed Anemia Due to Chemotherapy

This study has been completed.
Information provided by:
Amgen Identifier:
First received: June 30, 2005
Last updated: December 20, 2007
Last verified: December 2007

June 30, 2005
December 20, 2007
October 2002
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Anemia correction
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Complete list of historical versions of study NCT00120679 on Archive Site
  • Patient preference
  • Activities of daily living
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Treatment for Patients With Non-Small Cell Lung Cancer Who Developed Anemia Due to Chemotherapy
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

The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-AT) in non small cell lung cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.

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Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-Small Cell Lung Cancer
  • Anemia
  • Drug: darbepoetin alfa
  • Drug: recombinant human erythropoietin (rHuEPO)
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Schwartzberg LS, Yee LK, Senecal FM, Charu V, Tomita D, Wallace J, Rossi G. A randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia in patients with breast, lung, or gynecologic cancer. Oncologist. 2004;9(6):696-707.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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December 2003
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Inclusion Criteria: - Subjects receiving multi-cycle chemotherapy for non-small cell lung cancer - 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

18 Years and older
Contact information is only displayed when the study is recruiting subjects
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Global Development Leader, Amgen Inc.
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Study Director: MD Amgen
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP