Epoetin Alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy

NCT00003600 | Completed Phase 3 DMC

• 3 other identifiers: NCCTG-979253CDR0000066673NCI-P98-0133
• Study Type: interventional
• Target: 344
• Locations: 2 countries
• Sites: 21

Brief Summary

RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients with cancer who are receiving chemotherapy. It is not yet known whether epoetin alfa is more effective than a placebo in treating anemia in patients receiving chemotherapy. PURPOSE: Randomized double blinded phase III trial to compare the effectiveness of epoetin alfa with a placebo in treating anemia in cancer patients who are receiving chemotherapy.

Conditions

Anemia; Breast Cancer; Chronic Myeloproliferative Disorders; Drug/Agent Toxicity by Tissue/Organ; Leukemia; Lung Cancer; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Precancerous Condition; Small Intestine Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

• Quality of life

  Up to 12 months

Secondary Outcomes (2)

• Predict response

  Up to 12 months

• Response rate

  Up to 12 months

Study Arms (2)

epoetin alfa

EXPERIMENTAL

Patients receiving chemotherapy are randomized to receive epoetin alfa subcutaneously once a week for a maximum of 16 weeks Quality of life is assessed at randomization and monthly throughout study. Patients are followed every 6 months for 1 year.

Biological: epoetin alfa

placebo

PLACEBO COMPARATOR

Patients receiving chemotherapy are randomized to receive placebo subcutaneously once a week for a maximum of 16 weeks. Quality of life is assessed at randomization and monthly throughout study. Patients are followed every 6 months for 1 year.

Other: placebo

Interventions

epoetin alfa BIOLOGICAL

epoetin alfa

placebo OTHER

placebo

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Anemic: Hemoglobin in males less than 11.5 g/dL; hemoglobin in females less than 10.0 g/dL No anemia secondary to B12, folic acid, or iron deficiency No anemia secondary to gastrointestinal bleed or hemolysis No anemia secondary to a primary or chemotherapy-induced myelodysplastic syndrome No anemia secondary to acute lymphocytic leukemia Histologically confirmed advanced malignancy Lung Breast Other Currently receiving myelosuppressive, cytotoxic chemotherapy for advanced cancer No patients receiving adjuvant therapy for cancer that has been surgically removed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 4 months Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Cardiovascular: No uncontrolled hypertension (systolic at least 180, diastolic at least 100) Other: Normal or elevated ferritin No known hypersensitivity to epoetin alfa Must be able to reliably take oral medication Must be alert and mentally competent Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 year since prior epoetin alfa At least 2 weeks since prior red blood cell transfusions No concurrent peripheral blood stem cell or bone marrow transplantation Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Concurrent radiotherapy allowed Surgery: See Disease Characteristics

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 (21)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Howard University Cancer Center

Washington D.C., District of Columbia, 20060, 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 - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, 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 - Ochsner

New Orleans, Louisiana, 70121, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Clinic

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68131, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Altru Health Systems

Grand Forks, North Dakota, 58201, United States

Location

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, 43623-3456, 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, 57105-1080, United States

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

MeSH Terms

Conditions

Anemia; Breast Neoplasms; Myeloproliferative Disorders; Drug-Related Side Effects and Adverse Reactions; Leukemia; Lung Neoplasms; Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Precancerous Conditions

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Bone Marrow Diseases; Chemically-Induced Disorders; Neoplasms by Histologic Type; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lymphoproliferative Disorders; 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

• Thomas E. Witzig, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: February 20, 2004
• Study Start: December 1, 1998
• Primary Completion: December 1, 2001
• Study Completion: January 1, 2010
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (20); CA (1)