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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00121030

Enrollment

Unknown

Registered

2005-07-21

Start date

2002-10-31

Completion date

2003-12-31

Last updated

2007-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Genital Neoplasms, Female, Gynecological Malignancies

Keywords

uterine cancer, ovarian cancer, darbepoetin alfa, Amgen, Gynecological Malignancies

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.

Interventions

DRUGdarbepoetin alfa

DRUGrecombinant human erythropoietin (rHuEPO)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Anemia correction	—

Secondary

Measure	Time frame
Patient preference	—
Activities of daily living	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026