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
18 Years
N/A
Both
Anemia, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
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
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of a nonmyeloid malignancy
- Cancer- or chemotherapy-related anemia
- Hemoglobin 9.0-11.0 g/dL
- Currently receiving chemotherapy on a 3-week course schedule
- Myelosuppressive chemotherapy must not be administered on course days 9-21
- At least 2 additional courses of chemotherapy planned
- No other primary hematologic disorder that would cause anemia (e.g., sickle cell
anemia)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Bilirubin less than 2 times upper limit of normal (ULN)
Renal:
- Creatinine less than 2 times ULN
Cardiovascular:
- No uncontrolled angina
- No congestive heart failure
- No New York Heart Association class III-IV cardiac disease
- No uncontrolled hypertension
- No cardiac arrhythmia
- No other unstable or uncontrolled cardiac disease or condition
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No seizure disorder
- No clinically significant inflammatory disease
- No hypersensitivity to recombinant mammalian-derived products
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior epoetin alfa or darbepoetin alfa
- No other concurrent epoetin alfas
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- Concurrent radiotherapy allowed
Surgery:
- Not specified
Other:
- At least 30 days since prior investigational drugs or devices
- No prior enrollment on this study
- No other concurrent investigational drugs
- No more than 2 red blood cell (RBC) transfusions within the past 4 weeks
- No RBC transfusions during the chemotherapy course before randomization
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Principal Investigator
John A. Glaspy, MD, MPH
Investigator Role:
Study Chair
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000069366
NCT ID:
NCT00039247
Start Date:
Completion Date:
Related Keywords:
- Anemia
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- anemia
- Anemia
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