NCT00052221

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2003

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4 months until next milestone

Study Start

First participant enrolled

May 20, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
Last Updated

November 8, 2018

Status Verified

November 1, 2018

Enrollment Period

1.5 years

First QC Date

January 24, 2003

Last Update Submit

November 7, 2018

Conditions

FatigueUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificfatigue

Study Arms (2)

Arm I: Epoetin Alfa

EXPERIMENTAL

Epoetin alfa subcutaneously (SC) once weekly for 6 weeks

Biological: Epoetin alfa

Arm II: Placebo

PLACEBO COMPARATOR

Placebo subcutaneously (SC) once weekly for 6 weeks

Other: Placebo

Interventions

Epoetin alfaBIOLOGICAL
Arm I: Epoetin Alfa
PlaceboOTHER
Arm II: Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Fatigue

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Michael J. Fisch, MD, MPH, FACP

    M.D. Anderson Cancer Center

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

May 20, 2003

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

November 8, 2018

Record last verified: 2018-11