Epoetin Alfa in Treating Fatigue in Patients With Advanced Solid Tumors Who Are Not Receiving Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00052221
Recruitment Status : Withdrawn
First Posted : January 27, 2003
Last Update Posted : April 6, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Fatigue Unspecified Adult Solid Tumor, Protocol Specific Biological: Epoetin alfa Other: Placebo Not Applicable

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: A Placebo Controlled Trial Of Short-Term, High-Dose Epoetin Alfa In Advanced Cancer Outpatients With Mild Fatigue
Study Start Date : May 2003
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm I: Epoetin Alfa
Epoetin alfa subcutaneously (SC) once weekly for 6 weeks
Biological: Epoetin alfa
Placebo Comparator: Arm II: Placebo
Placebo subcutaneously (SC) once weekly for 6 weeks
Other: Placebo

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • Eastern Cooperative Oncology Group (ECOG) 0-3

Life expectancy:

  • At least 12 weeks


  • 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


  • Not specified


  • Not specified


  • 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


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


  • 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


Biologic therapy:

  • See Chemotherapy
  • More than 4 weeks since prior biologic therapy (e.g., interferon or interleukin-2)
  • More than 2 months since prior red blood cells (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


  • 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)


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


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00052221

Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Michael J. Fisch, MD, MPH, FACP M.D. Anderson Cancer Center

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00052221     History of Changes
Obsolete Identifiers: NCT00563719
Other Study ID Numbers: CDR0000069409
DM02-331 ( Other Identifier: UT MD Anderson Cancer Center )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: October 2012

Keywords provided by M.D. Anderson Cancer Center:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Signs and Symptoms
Epoetin Alfa