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

This study has been completed.
Information provided by:
Amgen Identifier:
First received: June 30, 2005
Last updated: December 20, 2007
Last verified: December 2007

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 Intervention Phase
Gynecological Malignancies
Genital Neoplasms, Female
Drug: darbepoetin alfa
Drug: recombinant human erythropoietin (rHuEPO)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Anemia correction

Secondary Outcome Measures:
  • Patient preference
  • Activities of daily living

Study Start Date: October 2002
Estimated Study Completion Date: December 2003

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Please refer to this study by its identifier: NCT00121030

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00121030     History of Changes
Other Study ID Numbers: 20020166
Study First Received: June 30, 2005
Last Updated: December 20, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Amgen:
uterine cancer
ovarian cancer
darbepoetin alfa
Gynecological Malignancies

Additional relevant MeSH terms:
Genital Neoplasms, Female
Hematologic Diseases
Urogenital Neoplasms
Neoplasms by Site
Darbepoetin alfa
Epoetin Alfa
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 17, 2014