Voriconazole and Caspofungin Acetate in Treating Invasive Fungal Infections in Patients With Weakened Immune Systems
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.
|Infection Unspecified Adult Solid Tumor, Protocol Specific||Drug: caspofungin acetate Drug: voriconazole||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Phase II Trial of Voriconazole Plus Caspofungin for the Initial Treatment of Invasive Fungal Infections|
- Number of Participants With a Complete or Partial Response Rate to the Combination of Voriconazole and Caspofungin at 12 Weeks. [ Time Frame: 12 weeks after starting treatment ]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.
- Duration of Survival up to 12 Weeks [ Time Frame: up to 12 weeks ]
- Safety [ Time Frame: duration of study ]
|Study Start Date:||August 2003|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
|Experimental: Voriconazole plus Caspofungin||
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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238355
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239-3098|
|Study Chair:||Lynne Strasfeld, MD||OHSU Knight Cancer Institute|