Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer

Sponsor

Jonsson Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00255749

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia caused by cancer and chemotherapy.

PURPOSE: This randomized phase II trial is studying how well epoetin alfa works in treating patients with anemia who are undergoing chemotherapy for cancer.

Condition or Disease	Intervention/Treatment	Phase
Anemia Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Precancerous Condition Unspecified Adult Solid Tumor, Protocol Specific	Biological: epoetin alfa	Phase 2

Detailed Description

OBJECTIVES:

Primary

Determine the efficacy, in terms of maintenance of target hemoglobin and hematocrit levels, of interval dosing with epoetin alfa in patients with anemia undergoing chemotherapy for nonmyeloid cancer.
Determine the safety of this drug in these patients.

Secondary

Determine the quality of life of patients treated with this drug.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

Arm I (early intervention): Patients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses.
Arm II (standard intervention): Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL.

Quality of life is assessed prior to start of study treatment, at week 7 during study treatment, and after completion of study treatment.

After completion of study treatment, patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Actual Enrollment :

89 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Assessment of Early and Standard Intervention With Procrit® (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy

Study Start Date :

Aug 1, 2005

Actual Primary Completion Date :

Apr 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: early intervention epoietin alfa Patients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses.	Biological: epoetin alfa
Other: standard intervention epoietin alfa Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL.	Biological: epoetin alfa

Arm

Intervention/Treatment

Experimental: early intervention epoietin alfa

Patients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses.

Biological: epoetin alfa

Other: standard intervention epoietin alfa

Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL.

Biological: epoetin alfa

Outcome Measures

Primary Outcome Measures

Efficacy [7 weeks]
Safety [7 weeks]

Secondary Outcome Measures

Quality of life [7 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed nonmyeloid cancer
No history of myelodysplasia
Baseline hemoglobin 11-12 g/dL
No anemia due to factors other than cancer or chemotherapy (e.g., iron, cyanocobalamin [vitamin B_12], or folate deficiencies, hemolysis, or gastrointestinal bleeding)
Receiving chemotherapy that meets the following criteria:
Administered weekly OR every 3 weeks
Must begin chemotherapy on or before the first day of study treatment
No known, untreated CNS metastases

PATIENT CHARACTERISTICS:

Performance status

ECOG 0-2

Life expectancy

At least 6 months

Hematopoietic

See Disease Characteristics
Absolute neutrophil count ≥ 1,000/mm^3
Platelet count ≥ 100,000/mm^3 (transfusion independent)
Iron transferrin saturation > 20%
No history of chronic hypercoagulable disorders (e.g., activated protein C resistance, anti-cardiolipin disorder, protein C deficiency, or protein S deficiency)

Hepatic

Bilirubin < 2.0 mg/dL
SGPT ≤ 3 times upper limit of normal

Renal

Creatinine ≤ 1.5 mg/dL
No significant, uncontrolled genitourinary disease or dysfunction

Cardiovascular

No uncontrolled cardiac arrhythmia in the past 6 months
No uncontrolled hypertension
No deep vein thrombosis, ischemic stroke, or other arterial or venous thrombotic events
Superficial thromboses allowed
No other significant, uncontrolled cardiovascular disease or dysfunction

Pulmonary

No significant, uncontrolled pulmonary disease or dysfunction
No pulmonary emboli

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No infection requiring hospitalization or antibiotics in the past 14 days
No known hypersensitivity to mammalian cell-derived products or to human albumin
No new onset (in the past 3 months) poorly controlled seizures
No other active malignancy except basal cell carcinoma or carcinoma in situ
Not an employee of the investigator or study center or family members of the employee or the investigator
No significant, uncontrolled neurological, endocrine, or gastrointestinal disease or dysfunction

PRIOR CONCURRENT THERAPY:

Biologic therapy

See Chemotherapy
More than 3 months since prior erythropoietic agent (e.g., epoetin alfa, darbepoetin alfa, or gene-activated erythropoietin)
More than 4 weeks since prior packed red blood cell transfusion
No concurrent stem cell harvest of bone marrow
No concurrent interleukin-11
No other concurrent erythropoietic agent