Original Query: gynecology
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Treatment for Patients With Gynecological Malignancies Who Suffer From Anemia Due to Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00121030
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : December 24, 2007
Information provided by:

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 Type : Interventional  (Clinical Trial)
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 : October 2002
Estimated Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

Primary Outcome Measures :
  1. Anemia correction

Secondary Outcome Measures :
  1. Patient preference
  2. Activities of daily living

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00121030

Sponsors and Collaborators
Study Director: MD Amgen

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00121030     History of Changes
Other Study ID Numbers: 20020166
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: December 24, 2007
Last Verified: December 2007

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
Epoetin Alfa
Darbepoetin alfa