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

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT00121030

Collaborator

(none)

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gynecological Malignancies Genital Neoplasms, Female Anemia	Drug: darbepoetin alfa Drug: recombinant human erythropoietin (rHuEPO)	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Patients With Gynecological Malignancies Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy

Study Start Date :

Oct 1, 2002

Study Completion Date :

Dec 1, 2003

Outcome Measures

Primary Outcome Measures

Anemia correction []

Secondary Outcome Measures

Patient preference []
Activities of daily living []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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