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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255749
• Other study ID #: CDR0000449950
• Secondary ID: UCLA-0504038ORTH
• Status: Completed
• Phase: Phase 2
• First received: November 18, 2005
• Last updated: October 3, 2012
• Start date: August 2005

Study information

• Verified date: October 2012
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anemia
• Leukemia
• Lymphoma
• Lymphoproliferative Disorder
• Lymphoproliferative Disorders
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma
• Precancerous Condition
• Precancerous Conditions
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Biological:
• epoetin alfa

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy		7 weeks	No
Primary	Safety		7 weeks	Yes
Secondary	Quality of life		7 weeks	No