Back to resultsTreatment for Patients With Gynecological Malignancies Who Suffer From Anemia Due to Chemotherapy
Primary Purpose
Gynecological Malignancies, Genital Neoplasms, Female, Anemia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
darbepoetin alfa
recombinant human erythropoietin (rHuEPO)
Sponsored by
About this trial
This is an interventional treatment trial for Gynecological Malignancies focused on measuring uterine cancer, ovarian cancer, darbepoetin alfa, Amgen, Gynecological Malignancies
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Anemia correction
Secondary Outcome Measures
Patient preference
Activities of daily living
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00121030
Brief Title
Treatment for Patients With Gynecological Malignancies Who Suffer From Anemia Due to Chemotherapy
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 Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecological Malignancies, Genital Neoplasms, Female, Anemia
Keywords
uterine cancer, ovarian cancer, darbepoetin alfa, Amgen, Gynecological Malignancies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
darbepoetin alfa
Intervention Type
Drug
Intervention Name(s)
recombinant human erythropoietin (rHuEPO)
Primary Outcome Measure Information:
Title
Anemia correction
Secondary Outcome Measure Information:
Title
Patient preference
Title
Activities of daily living
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
15561813
Citation
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. doi: 10.1634/theoncologist.9-6-696.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Treatment for Patients With Gynecological Malignancies Who Suffer From Anemia Due to Chemotherapy
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