Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003600
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
1999-11-01
Brief Title:
Epoetin Alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase III Randomized Double-Blind Study of Erythropoietin Versus Placebo in Anemic Patients With Cancer Undergoing Chemotherapy
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 gdL vs severe or less than 9 gdL 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
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 gdL vs severe or less than 9 gdL 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-P98-0133 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066673 | REGISTRY | None | None |