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

November 7, 2018 updated by: M.D. Anderson Cancer Center

A Placebo Controlled Trial Of Short-Term, High-Dose Epoetin Alfa In Advanced Cancer Outpatients With Mild Fatigue

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.

Study Overview

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • Eastern Cooperative Oncology Group (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 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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm I: Epoetin Alfa
Epoetin alfa subcutaneously (SC) once weekly for 6 weeks
PLACEBO_COMPARATOR: Arm II: Placebo
Placebo subcutaneously (SC) once weekly for 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 20, 2003

Primary Completion (ACTUAL)

December 1, 2004

Study Completion (ACTUAL)

December 1, 2004

Study Registration Dates

First Submitted

January 24, 2003

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2018

Last Update Submitted That Met QC Criteria

November 7, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069409
  • MDA-DM-02331
  • MDA-DM-0038
  • NCI-P02-0225
  • DM02-331 (OTHER: UT MD Anderson Cancer Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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