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NCT00121030 Clinical Trial

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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00121030
Other study ID # 20020166
Secondary ID
Status Completed
Phase Phase 2
First received June 30, 2005
Last updated December 20, 2007
Start date October 2002
Est. completion date December 2003

Study information
Verified date December 2007
Source Amgen
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date December 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• darbepoetin alfa

• recombinant human erythropoietin (rHuEPO)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Amgen

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Anemia correction
Secondary Patient preference
Secondary Activities of daily living
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