Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00238355
Status:
TERMINATED
Last Update Posted:
2011-12-19
First Post:
2005-10-12
Brief Title:
Voriconazole and Caspofungin Acetate in Treating Invasive Fungal Infections in Patients With Weakened Immune Systems
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Phase II Trial of Voriconazole Plus Caspofungin for the Initial Treatment of Invasive Fungal Infections
Status:
TERMINATED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
competing study at site
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Voriconazole and caspofungin acetate may control invasive fungal infections in patients who have weakened immune systems
PURPOSE This phase II trial is studying how well giving voriconazole together with caspofungin acetate works in treating invasive fungal infections in patients with weakened immune systems
PURPOSE This phase II trial is studying how well giving voriconazole together with caspofungin acetate works in treating invasive fungal infections in patients with weakened immune systems
Detailed Description:
OBJECTIVES
Primary
Determine the 12-week complete and partial response rate in immunocompromised patients with invasive fungal infections treated with voriconazole and caspofungin acetate
Secondary
Determine the 12-week survival rate in patients treated with this regimen
Determine the safety of this regimen in these patients
OUTLINE Patients receive voriconazole orally or IV over 1 hour twice daily and caspofungin acetate IV over 1 hour once daily on days 1-84 Treatment continues in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 47 patients will be accrued for this study
Primary
Determine the 12-week complete and partial response rate in immunocompromised patients with invasive fungal infections treated with voriconazole and caspofungin acetate
Secondary
Determine the 12-week survival rate in patients treated with this regimen
Determine the safety of this regimen in these patients
OUTLINE Patients receive voriconazole orally or IV over 1 hour twice daily and caspofungin acetate IV over 1 hour once daily on days 1-84 Treatment continues in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 47 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 |
|---|---|---|---|
| OHSU-IRB-1379 | OTHER | OHSU IRB | None |
| OHSU-HEM-0346-L | OTHER | None | None |