Darbepoetin Alfa Compared With Epoetin Alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer
Completed · Phase 3
Conditions studied: Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous/Nonmalignant Condition, Unspecified Adult Solid Tumor, Protocol Specific
In brief
RATIONALE: Darbepoetin alfa and epoetin alfa may stimulate red blood cell production and treat anemia in patients who are receiving chemotherapy. It is not yet known whether darbepoetin alfa is more effective than epoetin alfa in treating patients with anemia. PURPOSE: Randomized phase III trial to compare the effectiveness of darbepoetin alfa with that of epoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer.
Key facts
- Study ID
- NCT00070382
- Run by
- Jonsson Comprehensive Cancer Center
- People needed
- 14
- Starts
- 2003-08-01
- Last updated by the study team
- 2020-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of a non-myeloid malignancy
- Currently receiving or planning to receive at least 8 weeks of cyclic cytotoxic chemotherapy
- Hemoglobin no greater than 11.0 g/dL
- 18 and over
- ECOG 0-2
- Bilirubin less than 2 times upper limit of normal (ULN)
- Creatinine less than 2 times ULN
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- More than 30 days since prior darbepoetin alfa or epoetin alfa
- More than 30 days since prior participation in investigational device or drug trials
You may not qualify if…
- The following diagnoses are excluded:
- Acute myeloid leukemia
- Chronic myeloid leukemia
- Acute lymphoblastic leukemia
- Hairy cell leukemia
- Burkitt's lymphoma
- Lymphoblastic lymphoma
- other primary hematologic disorder that would cause anemia (e.g., sickle cell anemia)
- angina
- congestive heart failure
- New York Heart Association class III or IV heart disease
- hypertension
- cardiac arrhythmia
- other unstable or uncontrolled disease or condition that would affect cardiac function
- pregnant or nursing
- known seizure disorder
- known sensitivity to study agents
- clinically significant inflammatory disease (e.g., rheumatoid arthritis or Crohn's disease)
- confirmed neutralizing antibodies to epoetin alfa
- other disorder that would preclude study compliance or giving informed consent
- other concurrent epoetin alfas
- prior randomization to this study
- other concurrent investigational agents or procedures
Where it is running
- Jonsson Comprehensive Cancer Center, UCLA — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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