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	Treatment or Intervention
unspecified adult solid tumor, protocol specific Fatigue	Drug: epoetin alfa  Procedure: fatigue assessment/management  Procedure: supportive care/therapy

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 12 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

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., LHRH agonists or tamoxifen)

Radiotherapy:

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

Surgery:

• Not specified

Colorado
      CCOP - Colorado Cancer Research Program, Incorporated, Denver,  Colorado,  80224,  United States
Illinois
      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612-7323,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Michigan
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States
Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States
Ohio
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States
      CCOP - Dayton, Dayton,  Ohio,  45429,  United States
South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States
Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States
Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States

Study chairs or principal investigators

Michael J. Fisch, MD, MPH,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000069409; MDA-DM-02331; MDA-DM-0038; NCI-P02-0225
Record last reviewed:  February 2005
Last Updated:  February 17, 2005
Record first received:  January 24, 2003
ClinicalTrials.gov Identifier:  NCT00052221
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08