Treatment for Patients With Gynecological Malignancies Who Suffer From Anemia Due to Chemotherapy - Full Text View

Purpose

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 Anemia	Drug: darbepoetin alfa Drug: recombinant human erythropoietin (rHuEPO)	Phase II

MedlinePlus related topics:

Anemia Cancer

Drug Information available for:

Epoetin alfa Erythropoietin Darbepoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

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

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

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121030

Sponsors and Collaborators

Amgen

Investigators


Study Director:	MD	Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

ClinicalStudyResults website - Results posting for study 20020166 This link exits the ClinicalTrials.gov site

Publications:

Schwartzberg LS, Yee LK, Senecal FM, Charu V, Tomita D, Wallace J, Rossi G. A randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia in patients with breast, lung, or gynecologic cancer. Oncologist. 2004;9(6):696-707.

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20020166
First Received:	June 30, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00121030
Health Authority:	United States: Institutional Review Board

Keywords provided by Amgen:

uterine cancer

ovarian cancer

darbepoetin alfa

Amgen

Gynecological Malignancies

Study placed in the following topic categories:

Epoetin Alfa

Ovarian cancer

Ovarian Neoplasms

Hematologic Diseases

Darbepoetin alfa

Anemia

Genital Neoplasms, Female

Uterine Neoplasms

Urogenital Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Hematinics

Therapeutic Uses

Hematologic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 28, 2008

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00121030