Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052221
Status:
WITHDRAWN
Last Update Posted:
2018-11-08
First Post:
2003-01-24
Brief Title:
Epoetin Alfa in Treating Fatigue in Patients With Advanced Solid Tumors Who Are Not Receiving Chemotherapy
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Placebo Controlled Trial Of Short-Term High-Dose Epoetin Alfa In Advanced Cancer Outpatients With Mild Fatigue
Status:
WITHDRAWN
Status Verified Date:
2018-11
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 help improve energy levels and quality of life in patients who have advanced solid tumors
PURPOSE Randomized clinical trial to study the effectiveness of epoetin alfa in treating fatigue in patients who are not receiving chemotherapy for advanced solid tumors
PURPOSE Randomized clinical trial to study the effectiveness of epoetin alfa in treating fatigue in patients who are not receiving chemotherapy for advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the efficacy of epoetin alfa in treating fatigue in patients with advanced solid tumors who are not receiving chemotherapy
Determine the efficacy of this drug on functional status and overall quality of life in these patients
Correlate self-reported level of energy with other commonly occurring symptoms eg pain depression anxiety dyspnea appetite disturbance or sleep disturbance in these patients
Correlate anemia with other common symptoms in these patients
Determine the internal consistency of fatigue self-report using three single-item measures of this symptom and the responsiveness of each item to change over time in these patients
OUTLINE This is a double-blind placebo-controlled randomized multicenter study Patients are stratified according to participating center ECOG performance status 0-1 vs 2-3 and hemoglobin prior to study 10 mgdL or less vs greater than10 mgdL Patients are randomized to one of two treatment arms
Arm I Patients receive epoetin alfa subcutaneously SC once weekly for 6 weeks
Arm II Patients receive placebo SC once weekly for 6 weeks Patients in either arm that do not respond to therapy may receive an additional 6 weeks of open-label epoetin alfa SC once weekly
In both arms quality of life and fatigue are assessed at baseline and at 3 and 6 weeks If patients receive an additional 6 weeks of therapy quality of life and fatigue are also assessed at 9 and 12 weeks
PROJECTED ACCRUAL A total of 128 patients 64 per treatment arm will be accrued for this study
Determine the efficacy of epoetin alfa in treating fatigue in patients with advanced solid tumors who are not receiving chemotherapy
Determine the efficacy of this drug on functional status and overall quality of life in these patients
Correlate self-reported level of energy with other commonly occurring symptoms eg pain depression anxiety dyspnea appetite disturbance or sleep disturbance in these patients
Correlate anemia with other common symptoms in these patients
Determine the internal consistency of fatigue self-report using three single-item measures of this symptom and the responsiveness of each item to change over time in these patients
OUTLINE This is a double-blind placebo-controlled randomized multicenter study Patients are stratified according to participating center ECOG performance status 0-1 vs 2-3 and hemoglobin prior to study 10 mgdL or less vs greater than10 mgdL Patients are randomized to one of two treatment arms
Arm I Patients receive epoetin alfa subcutaneously SC once weekly for 6 weeks
Arm II Patients receive placebo SC once weekly for 6 weeks Patients in either arm that do not respond to therapy may receive an additional 6 weeks of open-label epoetin alfa SC once weekly
In both arms quality of life and fatigue are assessed at baseline and at 3 and 6 weeks If patients receive an additional 6 weeks of therapy quality of life and fatigue are also assessed at 9 and 12 weeks
PROJECTED ACCRUAL A total of 128 patients 64 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| DM02-331 | OTHER | UT MD Anderson Cancer Center | None |
| MDA-DM-02331 | None | None | None |
| MDA-DM-0038 | None | None | None |
| NCI-P02-0225 | None | None | None |