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

Amgen

Status and phase: Completed; Phase 2

Conditions: Anemia; Genital Neoplasms, Female; Gynecological Malignancies

Treatments: Drug: recombinant human erythropoietin (rHuEPO); Drug: darbepoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00121030

20020166

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)