Epoetin Alfa in Treating Anemia in Patients With Solid Tumors

NCT00058331 | Completed Phase 3 DMC

• 2 other identifiers: NCCTG-N02C2CDR0000288821
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 18

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Compare the effects of these regimens on increasing hemoglobin levels

  Up to 1 year post-treatment

Secondary Outcomes (2)

• 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 QOL

  Up to 1 year post-treatment

Study Arms (2)

epoetin alfa - long term dosing

EXPERIMENTAL

Patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Then patients receive EPO SC once weekly for 18 weeks. Quality of life is assessed at randomization at then monthly during study treatment. Patients are followed every 6 months for 1 year.

Biological: epoetin alfa

epoetin alfa - short term dosing

EXPERIMENTAL

Patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. 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.

Biological: epoetin alfa

Interventions

epoetin alfa BIOLOGICAL

epoetin alfa - long term dosing; epoetin alfa - short term dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (18)

CCOP - Mayo Clinic Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Altru Cancer Center

Grand Forks, North Dakota, 58201, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623-3456, United States

Location

CCOP - Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

Related Publications (2)

• 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. J Clin Oncol. 2006 Mar 1;24(7):1079-89. doi: 10.1200/JCO.2005.02.7276.

  PMID: 16505427 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Anemia; Leukemia; Lymphoma; Lymphoproliferative Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Precancerous Conditions

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• David P. Steensma, MD

  Dana-Farber Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2003
• First Posted: April 9, 2003
• Study Start: June 1, 2003
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: July 18, 2016

Record last verified: 2016-07

Locations

US (18)