Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Epoetin alfa in Treating Anemia in Patients With Solid Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Closed 18 and over NCI NCCTG-N02C2 NCT00058331

Objectives

1. Compare the effects of 2 different schedules of epoetin alfa on decreasing transfusion requirements in anemic patients with nonmyeloid cancer.
2. Compare the effects of these regimens on increasing hemoglobin levels in these patients.
3. Compare the effects of these regimens on overall quality of life (QOL) and anemia-specific components of QOL in these patients.

Entry 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:
  • B₁₂, 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

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

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• More than 14 days since prior major surgery

Other

• More than 2 weeks since prior red blood cell transfusions

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 6 months

Hematopoietic

• See Disease Characteristics

Hepatic

• Not specified

Renal

• Not specified

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

Expected Enrollment

A total of 330 patients (165 per treatment arm) will be accrued for this study.

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.

• Arm I: Patients receive EPO SC once weekly for 18 weeks.



• Arm II: Patients receive EPO SC on day 1 of weeks 4, 7, 10, 13, 16, and 19.

Quality of life is assessed at randomization at then monthly during study treatment.

Patients are followed every 6 months for 1 year.

Steensma DP, Molina R, Sloan JA, et al.: Phase III study of two different dosing schedules of erythropoietin in anemic patients with cancer. J Clin Oncol 24 (7): 1079-89, 2006.[PUBMED Abstract]

Steensma DP, Molina R, Sloan JA, et al.: A phase III randomized trial of two different dosing schedules of erythropoietin (EPO) in patients with cancer-associated anemia: North Central Cancer Treatment Group (NCCTG) study N02C2. [Abstract] J Clin Oncol 23 (Suppl 16): A-8031, 736s, 2005.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

David Steensma, MD, Protocol chair		Ph: 507-284-2511

Registry Information
Official Title		A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer
Trial Start Date		2003-06-06
Registered in ClinicalTrials.gov		NCT00058331
Date Submitted to PDQ		2003-02-28
Information Last Verified		2004-05-07

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