Trials / Completed
CompletedNCT00003600
Epoetin Alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy
A Phase III Randomized Double-Blind Study of Erythropoietin Versus Placebo in Anemic Patients With Cancer Undergoing Chemotherapy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 344 (actual)
- Sponsor
- Alliance for Clinical Trials in Oncology · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | epoetin alfa | |
| OTHER | placebo |
Timeline
- Start date
- 1998-12-01
- Primary completion
- 2001-12-01
- Completion
- 2010-01-01
- First posted
- 2004-02-20
- Last updated
- 2016-07-13
Locations
21 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00003600. Inclusion in this directory is not an endorsement.