Overview

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

Status:
Completed
Trial end date:
2003-12-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amgen
Treatments:
Darbepoetin alfa
Epoetin Alfa
Criteria
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