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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00255749
First received: November 18, 2005
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: August 2005
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
standard intervention epoietin alfa
Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL.
Biological: epoetin alfa

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00255749

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: John A. Glaspy, MD, MPH Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided by Jonsson Comprehensive Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00255749     History of Changes
Other Study ID Numbers: CDR0000449950, UCLA-0504038, ORTHO-PR04-27-018
Study First Received: November 18, 2005
Last Updated: October 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Jonsson Comprehensive Cancer Center:
adult acute lymphoblastic leukemia in remission
progressive hairy cell leukemia, initial treatment
stage 0 chronic lymphocytic leukemia
anemia
extramedullary plasmacytoma
isolated plasmacytoma of bone
refractory multiple myeloma
monoclonal gammopathy of undetermined significance
primary systemic amyloidosis
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
AIDS-related peripheral/systemic lymphoma
AIDS-related primary CNS lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult T-cell leukemia/lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma

Additional relevant MeSH terms:
Anemia
Neoplasms
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Precancerous Conditions
Lymphoma, Large-Cell, Immunoblastic
Hematologic Diseases
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hemorrhagic Disorders
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014