Phase II Trial of Voriconazole Plus Caspofungin for the Initial Treatment of Invasive Fungal Infections
- Determine the 12-week complete and partial response rate in immunocompromised patients
with invasive fungal infections treated with voriconazole and caspofungin acetate.
- 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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Number of Participants With a Complete or Partial Response Rate to the Combination of Voriconazole and Caspofungin at 12 Weeks.
Patients will be followed through day 84 (12 weeks), regardless of continuation of study drugs. Complete response: Resolution of all clinical signs and symptoms and more than 90 percent of the lesions due to invasive fungus that were visible by radiology. Partial response: Clinical improvement and greater than 50 percent improvement in the lesions due to invasive fungus that were visible by radiology.
12 weeks after starting treatment
Lynne Strasfeld, MD
OHSU Knight Cancer Institute
United States: Food and Drug Administration
|OHSU Knight Cancer Institute||Portland, Oregon 97239|