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

18 Years
Not Enrolling
Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


- 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

Inclusion Criteria


- 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

- 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


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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Principal Investigator

Michael J. Fisch, MD, MPH, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2003

Completion Date:

December 2004

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  • Unspecified Adult Solid Tumor, Protocol Specific
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  • fatigue
  • Fatigue