Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003938
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
1999-11-01
Brief Title:
Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Strategic Study to Determine the Optimal Moment to Initiate Systemic Antifungal Therapy With Ambisome in Granulocytopenic Cancer Patients With Unexplained Fever Refractory to Empirical Antibacterials
Status:
COMPLETED
Status Verified Date:
2012-09
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 Liposomal amphotericin B may be effective in controlling fever and granulocytopenia It is not yet known which regimen of liposomal amphotericin B is more effective in treating cancer patients who have these conditions
PURPOSE Randomized phase III trial to compare the effectiveness of two regimens of liposomal amphotericin B in treating granulocytopenia and fever in cancer patients
PURPOSE Randomized phase III trial to compare the effectiveness of two regimens of liposomal amphotericin B in treating granulocytopenia and fever in cancer patients
Detailed Description:
OBJECTIVES
Compare the efficacy and side effects of amphotericin B-liposomal formulation initiated 72-84 hours vs 144-156 hours after onset of a febrile episode in cancer patients with granulocytopenia and persistent unexplained fever refractory to antibacterials
OUTLINE This is a randomized multicenter study Patients are stratified according to antifungal prophylaxis yes vs no and type of underlying condition Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive amphotericin B-liposomal formulation IV over 1 hour on day 3 of febrile neutropenia
Arm II Patients receive amphotericin B-liposomal formulation IV over 1 hour on day 6 of febrile neutropenia
Treatment continues until signs and symptoms of the fungal infection appear or febrile neutropenia has resolved Persistently neutropenic patients receive treatment for at least 10 days or until another cause of infection is determined
Patients are followed weekly for 3 weeks
PROJECTED ACCRUAL A total of 450 patients will be accrued for this study
Compare the efficacy and side effects of amphotericin B-liposomal formulation initiated 72-84 hours vs 144-156 hours after onset of a febrile episode in cancer patients with granulocytopenia and persistent unexplained fever refractory to antibacterials
OUTLINE This is a randomized multicenter study Patients are stratified according to antifungal prophylaxis yes vs no and type of underlying condition Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive amphotericin B-liposomal formulation IV over 1 hour on day 3 of febrile neutropenia
Arm II Patients receive amphotericin B-liposomal formulation IV over 1 hour on day 6 of febrile neutropenia
Treatment continues until signs and symptoms of the fungal infection appear or febrile neutropenia has resolved Persistently neutropenic patients receive treatment for at least 10 days or until another cause of infection is determined
Patients are followed weekly for 3 weeks
PROJECTED ACCRUAL A total of 450 patients 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 |
|---|---|---|---|
| EORTC-19951 | None | None | None |