Treatment for Patients With Non-Small Cell Lung Cancer Who Developed Anemia Due to Chemotherapy
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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 Anemia |
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 |
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
Additional Information:
Publications:
Responsible Party: | Global Development Leader, Amgen Inc. |
ClinicalTrials.gov 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 Amgen |
Additional relevant MeSH terms:
Anemia Carcinoma, Non-Small-Cell Lung Lung Neoplasms Hematologic Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Darbepoetin alfa Epoetin Alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 16, 2012