Epoetin Alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00003600|
Recruitment Status : Completed
First Posted : February 20, 2004
Last Update Posted : July 13, 2016
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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||344 participants|
|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 :||December 1998|
|Actual Primary Completion Date :||December 2001|
|Actual Study Completion Date :||January 2010|
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.
- Quality of life [ Time Frame: Up to 12 months ]
- Predict response [ Time Frame: Up to 12 months ]
- Response rate [ Time Frame: Up to 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003600
|Study Chair:||Thomas E. Witzig, MD||Mayo Clinic|