NCT00238355

Voriconazole and Caspofungin Acetate in Treating Invasive Fungal Infections in Patients With Weakened Immune Systems

Phase II Trial of Voriconazole Plus Caspofungin for the Initial Treatment of Invasive Fungal Infections

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Infection
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	caspofungin acetate	70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84.
DRUG	voriconazole	6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses. Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours (at least one hour before or after meals).

Timeline

• Start date: 2003-08-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2005-10-13
• Last updated: 2025-04-27
• Results posted: 2011-12-09

Locations

1 site across 1 country: United States