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Epoetin Alfa in Treating Fatigue in Patients With Advanced Solid Tumors Who Are Not Receiving Chemotherapy
This study has been completed.
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00052221
  Purpose

RATIONALE: Epoetin alfa may help improve energy levels and quality of life in patients who have advanced solid tumors.

PURPOSE: Randomized clinical trial to study the effectiveness of epoetin alfa in treating fatigue in patients who are not receiving chemotherapy for advanced solid tumors.


Condition Intervention
Fatigue
Unspecified Adult Solid Tumor, Protocol Specific
Drug: epoetin alfa

MedlinePlus related topics: Cancer
Drug Information available for: Epoetin alfa Erythropoietin
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title: A Placebo Controlled Trial Of Short-Term, High-Dose Epoeitin Alfa In Advanced Cancer Outpatients With Mild Fatigue

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2003
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the efficacy of epoetin alfa in treating fatigue in patients with advanced solid tumors who are not receiving chemotherapy.
  • Determine the efficacy of this drug on functional status and overall quality of life in these patients.
  • Correlate self-reported level of energy with other commonly occurring symptoms (e.g., pain, depression, anxiety, dyspnea, appetite disturbance, or sleep disturbance) in these patients.
  • Correlate anemia with other common symptoms in these patients.
  • Determine the internal consistency of fatigue self-report using three single-item measures of this symptom and the responsiveness of each item to change over time in these patients.

OUTLINE: This is a double-blind, placebo-controlled, randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0-1 vs 2-3), and hemoglobin prior to study (10 mg/dL or less vs greater than10 mg/dL). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive epoetin alfa subcutaneously (SC) once weekly for 6 weeks.
  • Arm II: Patients receive placebo SC once weekly for 6 weeks. Patients in either arm that do not respond to therapy may receive an additional 6 weeks of open-label epoetin alfa SC once weekly.

In both arms, quality of life and fatigue are assessed at baseline and at 3 and 6 weeks. If patients receive an additional 6 weeks of therapy, quality of life and fatigue are also assessed at 9 and 12 weeks.

PROJECTED ACCRUAL: A total of 128 patients (64 per treatment arm) 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:

  • Diagnosis of stage III or IV invasive non-myeloid malignancy
  • Not currently hospitalized
  • At least somewhat bothered by fatigue based on self-report

    • No significant psychological distress indicated by total score of 6 or more on questions 1 and 2 of the Three-Question Screening Survey (3QSS)
    • No score less than 2 on question 3 of 3QSS indicating low level of fatigue within the past week
  • No uncontrolled brain metastases or leptomeningeal involvement

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-3

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Hemoglobin at least 8.5 g/dL but no greater than 11 g/dL
  • No anemia due to factors other than cancer or chemotherapy (e.g., iron or folate deficiency, hemolysis, or bleeding)
  • No prior or concurrent hematological disease

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • No uncontrolled hypertension (diastolic blood pressure greater than 100 mm Hg or systolic blood pressure greater than 200 mm Hg)
  • No significant uncontrolled concurrent cardiovascular disease or dysfunction not attributable to malignancy or chemotherapy
  • No history of deep-vein thrombosis

Pulmonary:

  • No significant uncontrolled concurrent pulmonary disease or dysfunction not attributable to malignancy or chemotherapy

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • Able to understand and complete self-report symptom assessment forms in English
  • No serious concurrent infection
  • No known hypersensitivity to mammalian cell-derived products or human albumin
  • No uncontrolled seizures
  • No significant uncontrolled concurrent endocrine, neurologic, gastrointestinal, or genitourinary system disease or dysfunction not attributable to malignancy or chemotherapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Chemotherapy
  • More than 4 weeks since prior biologic therapy (e.g., interferon or interleukin-2)
  • More than 2 months since prior RBC transfusion
  • More than 1 month since prior epoetin alfa or investigational forms of epoetin alfa (e.g., gene-activated, novel erythropoiesis-stimulating protein)
  • Concurrent non-myelosuppressive therapy (e.g., monoclonal antibody infusions, antiangiogenesis inhibitors, or signal transduction inhibitors) allowed
  • No other concurrent biologic therapy

Chemotherapy:

  • No prior high-dose chemotherapy (e.g., with bone marrow or stem cell transplantation)
  • More than 4 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • Concurrent hormonal therapy allowed (e.g., luteinizing hormone-releasing hormone agonists or tamoxifen)

Radiotherapy:

  • More than 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052221

Locations
United States, Colorado
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224
United States, Illinois
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612-7323
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Michigan
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
United States, Ohio
CCOP - Columbus
Columbus, Ohio, United States, 43206
CCOP - Dayton
Dayton, Ohio, United States, 45429
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Michael J. Fisch, MD, MPH, FACP M.D. Anderson Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000069409, MDA-DM-02331, MDA-DM-0038, NCI-P02-0225
Study First Received: January 24, 2003
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00052221  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
fatigue

Study placed in the following topic categories:
Epoetin Alfa
Signs and Symptoms
Fatigue

Additional relevant MeSH terms:
Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009