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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00052221
First received: January 24, 2003
Last updated: October 18, 2012
Last verified: October 2012
  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
Biological: epoetin alfa

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Enrollment: 0
Study Start Date: May 2003
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I: Epoetin Alfa
Epoetin alfa subcutaneously (SC) once weekly for 6 weeks
Biological: epoetin alfa
Placebo Comparator: Arm II: Placebo

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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052221

Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Michael J. Fisch, MD, MPH, FACP M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00052221     History of Changes
Obsolete Identifiers: NCT00563719
Other Study ID Numbers: CDR0000069409, MDA-DM-02331, MDA-DM-0038, NCI-P02-0225, DM02-331
Study First Received: January 24, 2003
Last Updated: October 18, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014