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

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

Sponsors

Lead sponsor: Amgen

Source Amgen
Brief Summary

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.

Overall Status Completed
Start Date October 2002
Completion Date December 2003
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Anemia correction
Secondary Outcome
Measure Time Frame
Patient preference
Activities of daily living
Condition
Intervention

Intervention type: Drug

Intervention name: darbepoetin alfa

Intervention type: Drug

Intervention name: recombinant human erythropoietin (rHuEPO)

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
MD Study Director Amgen
Verification Date

December 2007

Responsible Party

Name title: Global Development Leader

Organization: Amgen Inc.

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov