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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00052221
• Other study ID #: CDR0000069409
• Secondary ID: MDA-DM-02331MDA-
• Status: Withdrawn
• Phase: N/A
• Start date: May 20, 2003
• Est. completion date: December 2004

Study information

• Verified date: November 2018
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00563719

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Biological:
• Epoetin alfa

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)