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Epoetin Alfa in Treating Anemia in Patients With Solid Tumors

A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00058331
Enrollment
365
Registered
2003-04-09
Start date
2003-06-30
Completion date
2006-05-31
Last updated
2016-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition, Unspecified Adult Solid Tumor, Protocol Specific

Brief summary

RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients with solid tumors. It is not yet known whether epoetin alfa given once a week is more effective than epoetin alfa given once every 3 weeks in treating anemia. PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have solid tumors.

Detailed description

OBJECTIVES: * Compare the effects of 2 different schedules of epoetin alfa on decreasing transfusion requirements in anemic patients with nonmyeloid cancer. * Compare the effects of these regimens on increasing hemoglobin levels in these patients. * Compare the effects of these regimens on overall quality of life (QOL) and anemia-specific components of QOL in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to concurrent chemotherapy or radiotherapy (yes vs no), concurrent platinum-based (cisplatin or carboplatin) chemotherapy (yes vs no), degree of anemia (mild \[hemoglobin at least 9.0 g/dL\] vs severe \[hemoglobin less than 9.0 g/dL\]), age (60 and under vs over 60), and type of neoplasm (plasma cell disorder \[including multiple myeloma\] or lymphoproliferative disorder \[including non-Hodgkin's lymphoma and chronic lymphocytic leukemia\] vs all other neoplasms). All patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Patients are then randomized to 1 of 2 treatment arms.

Interventions

BIOLOGICALepoetin alfa

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Diagnosis of a nonmyeloid cancer (excluding nonmelanoma skin cancer) * Anemia secondary to cancer or cancer treatment\* * Hemoglobin less than 12 g/dL (males) * Hemoglobin less than 11 g/dL (females) NOTE: \*Active anticancer therapy is not required for study enrollment * Anemia must not be secondary to any of the following: * B\_12, folic acid, or iron deficiency * Ferritin must be normal or elevated * Gastrointestinal bleeding or hemolysis * Primary or chemotherapy-induced myelodysplastic syndromes * No untreated CNS metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 6 months Cardiovascular * No history of uncontrolled cardiac arrhythmias * No history of deep venous thrombosis within the past year (unless on anticoagulation) * No uncontrolled hypertension (systolic blood pressure at least 180 mm Hg and diastolic blood pressure at least 100 mm Hg) within the past year (unless on anticoagulation) Pulmonary * No history of pulmonary embolism within the past year (unless on anticoagulation) Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * No known hypersensitivity to epoetin alfa, mammalian cell-derived products, or human albumin * No new onset of seizures within the past 3 months * No poorly controlled seizures * Able and willing to complete quality of life forms * Alert and mentally competent to give informed consent PRIOR CONCURRENT THERAPY: Biologic therapy * More than 6 months since prior epoetin alfa * More than 6 months since any prior investigational forms of epoetin alfa (e.g., gene-activated epoetin alfa or novel erythropoiesis-stimulating protein) * No concurrent peripheral blood stem cell transplantation * No concurrent bone marrow transplantation Surgery * More than 14 days since prior major surgery Other * More than 2 weeks since prior red blood cell transfusions

Design outcomes

Primary

MeasureTime frame
Compare the effects of these regimens on increasing hemoglobin levelsUp to 1 year post-treatment

Secondary

MeasureTime frame
Compare the effects of these regimens on overall quality of life (QOL)Up to 1 year post-treatment
Compare the effects of anemia-specific components of QOLUp to 1 year post-treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026