Treatment for Patients With Gynecological Malignancies Who Suffer From Anemia Due to Chemotherapy

Phase 2

Completed

• Conditions: Gynecological Malignancies; Genital Neoplasms, Female; Anemia

• Registration Number: NCT00121030
• Lead Sponsor: Amgen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Study Completion: 2003-12
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-07-19
• Study First Posted: 2005-07-21
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-20
• Last Update Posted: 2007-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Subjects receiving multi-cycle chemotherapy for gynecological 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 - Known positive test for human immunodeficiency virus (HIV) infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anemia correction

Secondary Outcome Measures

Name	Time	Method
Patient preference
Activities of daily living