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.

Condition	Treatment or Intervention	Phase
Anemia unspecified adult solid tumor, protocol specific	Procedure: supportive care  Drug: hematologic toxicity attenuation  Behavior: supportive care/therapy  Drug: darbepoetin alfa	Phase II

Further Study Details: 

OBJECTIVES: I. 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. II. Determine the safety of this drug in these patients. III. Determine the pharmacokinetic profile of this drug in these patients.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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)

--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

--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

Study chairs or principal investigators

John A. Glaspy,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000069366; UCLA-0111006; NCI-G02-2071; AMGEN-20010162
Record last reviewed:  August 2003
Last Updated:  October 13, 2004
Record first received:  June 6, 2002
ClinicalTrials.gov Identifier:  NCT00039247
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08