Epoetin Alfa in Treating Anemia in Patients With Solid Tumors

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00058331
• Other study ID #: NCCTG-N02C2
• Secondary ID: CDR0000288821
• Status: Completed
• Phase: Phase 3
• First received: April 7, 2003
• Last updated: July 15, 2016
• Start date: June 2003
• Est. completion date: May 2006

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

Biological:
• epoetin alfa

Locations

Country	Name	City	State
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	CCOP - Duluth	Duluth	Minnesota
United States	CCOP - Merit Care Hospital	Fargo	North Dakota
United States	Altru Cancer Center	Grand Forks	North Dakota
United States	Mayo Clinic	Jacksonville	Florida
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	CCOP - Mayo Clinic Scottsdale Oncology Program	Scottsdale	Arizona
United States	Siouxland Hematology-Oncology	Sioux City	Iowa
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	CCOP - Oklahoma	Tulsa	Oklahoma
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Steensma DP, Molina R, Sloan JA, Nikcevich DA, Schaefer PL, Rowland KM Jr, Dentchev T, Novotny PJ, Tschetter LK, Alberts SR, Hogan TF, Law A, Loprinzi CL. Phase III study of two different dosing schedules of erythropoietin in anemic patients with cancer. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the effects of these regimens on increasing hemoglobin levels		Up to 1 year post-treatment	No
Secondary	Compare the effects of these regimens on overall quality of life (QOL)		Up to 1 year post-treatment	No
Secondary	Compare the effects of anemia-specific components of QOL		Up to 1 year post-treatment	No