Darbepoetin Alfa in Treating Anemia in Patients With Cancer Who Are Receiving Chemotherapy
Recruitment status was Active, not recruiting
RATIONALE: Darbepoetin alfa may stimulate red blood cell production and may be effective in treating anemia in patients who are receiving chemotherapy.
PURPOSE: Randomized phase II trial to determine the effectiveness of darbepoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer.
Unspecified Adult Solid Tumor, Protocol Specific
Biological: darbepoetin alfa
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Randomized, Open-Label, Dose-Timing Study Of Darbepoetin Alfa Administered Once Every 3 Weeks (Q3W) by Subcutaneous (SC) Injection For Treatment Of Anemia In Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy|
- Compare the efficacy of darbepotein alfa administered on the same day as chemotherapy vs an alternate time to chemotherapy administration for the treatment of anemia in patients with nonmyeloid malignancies receiving multiple courses of chemotherapy.
- Determine the safety of this drug in these patients.
- Determine the pharmacokinetic profile of this drug in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to screening hemoglobin (less than 10.0 g/dL vs 10.0-11.0 g/dL) and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive darbepoetin alfa subcutaneously (SC) on day 15 of each chemotherapy course.
- Arm II: Patients receive darbepoetin alfa SC on day 1 of each chemotherapy course.
In both arms, treatment repeats every 3 weeks for up to 5 courses in the absence of unacceptable toxicity or treatment failure.
PROJECTED ACCRUAL: A total of 80 patients (40 per arm) will be accrued for this study within 8 months.
|Study Chair:||John A. Glaspy, MD, MPH||Jonsson Comprehensive Cancer Center|