Epoetin Alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00003600

Collaborator

National Cancer Institute (NCI) (NIH)

344

Enrollment

Locations

Arms

133

Duration (Months)

16.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Biological: epoetin alfa Other: placebo	Phase 3

Detailed Description

OBJECTIVES: I. Determine whether epoetin alfa treatment improves the quality of life in anemic patients who are undergoing chemotherapy for advanced malignancy. II. Determine whether epoetin alfa increases hemoglobin levels and decreases transfusion requirements in these patients. III. Validate or refute the use of an algorithm using pre- and posttreatment epoetin alfa, ferritin, and hemoglobin levels to predict 16 weeks response or no response to therapeutic doses of epoetin alfa as set forth by these patients. IV. Explore whether anemic patients receiving platinum-containing chemotherapy regimens experience less nephrotoxicity if they receive concurrent epoetin alfa compared to those who receive placebo.

OUTLINE: This is a randomized, double blind study. Patients are stratified by primary malignant disease (lung vs breast vs other), life expectancy (4-6 months vs greater than 6 months), planned concurrent radiotherapy (yes vs no), and degree of anemia (mild or at least 9 g/dL vs severe or less than 9 g/dL). Patients receiving chemotherapy are randomized to receive epoetin alfa subcutaneously once a week for a maximum of 16 weeks (arm I) or placebo subcutaneously once a week for a maximum of 16 weeks (arm II). Quality of life is assessed at randomization and monthly throughout study. Patients are followed every 6 months for 1 year.

Study Design

Study Type:

Interventional

Actual Enrollment :

344 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

A Phase III Randomized Double-Blind Study of Erythropoietin Versus Placebo in Anemic Patients With Cancer Undergoing Chemotherapy

Study Start Date :

Dec 1, 1998

Actual Primary Completion Date :

Dec 1, 2001

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: epoetin alfa 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 Comparator: placebo 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

Arm

Intervention/Treatment

Experimental: epoetin alfa

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 Comparator: placebo

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

Outcome Measures

Primary Outcome Measures

Quality of life [Up to 12 months]

Secondary Outcome Measures

Predict response [Up to 12 months]
Response rate [Up to 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona	United States	85259-5404
2	Howard University Cancer Center	Washington	District of Columbia	United States	20060
3	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61602
4	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
5	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
6	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1016
7	Siouxland Hematology-Oncology	Sioux City	Iowa	United States	51101-1733
8	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
9	CCOP - Ochsner	New Orleans	Louisiana	United States	70121
10	CCOP - Duluth	Duluth	Minnesota	United States	55805
11	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
12	CentraCare Clinic	Saint Cloud	Minnesota	United States	56303
13	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68131
14	Medcenter One Health System	Bismarck	North Dakota	United States	58501
15	CCOP - Merit Care Hospital	Fargo	North Dakota	United States	58122
16	Altru Health Systems	Grand Forks	North Dakota	United States	58201
17	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio	United States	43623-3456
18	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania	United States	17822-2001
19	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57709
20	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57105-1080
21	Allan Blair Cancer Centre	Regina	Saskatchewan	Canada	S4T 7T1