Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058331
Status:
COMPLETED
Last Update Posted:
2016-07-18
First Post:
2003-04-07
Brief Title:
Epoetin Alfa in Treating Anemia in Patients With Solid Tumors
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase III Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer
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 solid tumors It is not yet known whether epoetin alfa given once a week is more effective than epoetin alfa given once every 3 weeks in treating anemia
PURPOSE Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have solid tumors
PURPOSE Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have solid tumors
Detailed Description:
OBJECTIVES
Compare the effects of 2 different schedules of epoetin alfa on decreasing transfusion requirements in anemic patients with nonmyeloid cancer
Compare the effects of these regimens on increasing hemoglobin levels in these patients
Compare the effects of these regimens on overall quality of life QOL and anemia-specific components of QOL in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to concurrent chemotherapy or radiotherapy yes vs no concurrent platinum-based cisplatin or carboplatin chemotherapy yes vs no degree of anemia mild hemoglobin at least 90 gdL vs severe hemoglobin less than 90 gdL age 60 and under vs over 60 and type of neoplasm plasma cell disorder including multiple myeloma or lymphoproliferative disorder including non-Hodgkins lymphoma and chronic lymphocytic leukemia vs all other neoplasms
All patients receive epoetin alfa EPO subcutaneously SC once weekly for 3 weeks Patients are then randomized to 1 of 2 treatment arms
Compare the effects of 2 different schedules of epoetin alfa on decreasing transfusion requirements in anemic patients with nonmyeloid cancer
Compare the effects of these regimens on increasing hemoglobin levels in these patients
Compare the effects of these regimens on overall quality of life QOL and anemia-specific components of QOL in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to concurrent chemotherapy or radiotherapy yes vs no concurrent platinum-based cisplatin or carboplatin chemotherapy yes vs no degree of anemia mild hemoglobin at least 90 gdL vs severe hemoglobin less than 90 gdL age 60 and under vs over 60 and type of neoplasm plasma cell disorder including multiple myeloma or lymphoproliferative disorder including non-Hodgkins lymphoma and chronic lymphocytic leukemia vs all other neoplasms
All patients receive epoetin alfa EPO subcutaneously SC once weekly for 3 weeks Patients are then randomized to 1 of 2 treatment arms
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 |
|---|---|---|---|
| CDR0000288821 | REGISTRY | PDQ Physician Data Query | None |