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
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.

Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: darbepoetin alfa
Drug: recombinant human erythropoietin (rHuEPO)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Anemia correction

Secondary Outcome Measures:
  • Patient preference
  • Activities of daily living

Study Start Date: October 2002
Estimated Study Completion Date: December 2003

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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Please refer to this study by its identifier: NCT00120679

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00120679     History of Changes
Other Study ID Numbers: 20020165
Study First Received: June 30, 2005
Last Updated: December 20, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Amgen:
non-small cell lung cancer
darbepoetin alfa

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Hematologic Diseases
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Darbepoetin alfa
Epoetin alfa
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 30, 2015