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

NCT ID: NCT00255749

Last Updated: 2012-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31

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.

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.

Conditions

Anemia; Leukemia; Lymphoma; Lymphoproliferative Disorder; Multiple Myeloma and Plasma Cell Neoplasm; Precancerous Condition; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

early intervention epoietin alfa

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

Group Type: EXPERIMENTAL

epoetin alfa

Intervention Type: BIOLOGICAL

standard intervention epoietin alfa

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

Group Type: OTHER

epoetin alfa

Intervention Type: BIOLOGICAL

Interventions

epoetin alfa

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

Chemotherapy

• See Disease Characteristics
• No concurrent high-dose chemotherapy with stem cell transplantation

Radiotherapy

• No concurrent nonpalliative radiotherapy

Surgery

• More than 2 weeks since prior major surgery

Other

• At least 1 month since prior investigational agents or devices
• No concurrent high-dose IV iron supplementation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John A. Glaspy, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Jonsson Comprehensive Cancer Center

Locations

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, United States

Countries

United States

References

Glaspy JA, Charu V, Luo D, Moyo V, Kamin M, Wilhelm FE. Initiation of epoetin-alpha therapy at a starting dose of 120,000 units once every 3 weeks in patients with cancer receiving chemotherapy: an open-label, multicenter study with randomized and nonrandomized treatment arms. Cancer. 2009 Mar 1;115(5):1121-31. doi: 10.1002/cncr.24127.

Reference Type: DERIVED

PMID: 19170225 (View on PubMed)

Other Identifiers

UCLA-0504038

Identifier Type: -

Identifier Source: secondary_id

ORTHO-PR04-27-018

Identifier Type: -

Identifier Source: secondary_id

CDR0000449950

Identifier Type: -

Identifier Source: org_study_id