Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Anemia correction
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
United States: Institutional Review Board
Study ID:
20020166
NCT ID:
NCT00121030
Start Date:
October 2002
Completion Date:
December 2003
Related Keywords:
- Gynecological Malignancies
- Genital Neoplasms, Female
- Anemia
- uterine cancer
- ovarian cancer
- darbepoetin alfa
- Amgen
- Gynecological Malignancies
- Anemia
- Neoplasms
- Genital Neoplasms, Female
