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

Primary Purpose

Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Epoetin alfa
Placebo
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fatigue focused on measuring unspecified adult solid tumor, protocol specific, fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Arm I: Epoetin Alfa

    Arm II: Placebo

    Arm Description

    Epoetin alfa subcutaneously (SC) once weekly for 6 weeks

    Placebo subcutaneously (SC) once weekly for 6 weeks

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 24, 2003
    Last Updated
    November 7, 2018
    Sponsor
    M.D. Anderson Cancer Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00052221
    Brief Title
    Epoetin Alfa in Treating Fatigue in Patients With Advanced Solid Tumors Who Are Not Receiving Chemotherapy
    Official Title
    A Placebo Controlled Trial Of Short-Term, High-Dose Epoetin Alfa In Advanced Cancer Outpatients With Mild Fatigue
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    May 20, 2003 (Actual)
    Primary Completion Date
    December 2004 (Actual)
    Study Completion Date
    December 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    M.D. Anderson Cancer Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
    Keywords
    unspecified adult solid tumor, protocol specific, fatigue

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm I: Epoetin Alfa
    Arm Type
    Experimental
    Arm Description
    Epoetin alfa subcutaneously (SC) once weekly for 6 weeks
    Arm Title
    Arm II: Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo subcutaneously (SC) once weekly for 6 weeks
    Intervention Type
    Biological
    Intervention Name(s)
    Epoetin alfa
    Intervention Type
    Other
    Intervention Name(s)
    Placebo

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael J. Fisch, MD, MPH, FACP
    Organizational Affiliation
    M.D. Anderson Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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