Voriconazole and Caspofungin Acetate in Treating Invasive Fungal Infections in Patients With Weakened Immune Systems
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|ClinicalTrials.gov Identifier: NCT00238355|
Recruitment Status : Terminated (competing study at site)
First Posted : October 13, 2005
Results First Posted : December 9, 2011
Last Update Posted : December 19, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Infection Unspecified Adult Solid Tumor, Protocol Specific||Drug: caspofungin acetate Drug: voriconazole||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Phase II Trial of Voriconazole Plus Caspofungin for the Initial Treatment of Invasive Fungal Infections|
|Study Start Date :||August 2003|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
|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).
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238355
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239-3098|
|Study Chair:||Lynne Strasfeld, MD||OHSU Knight Cancer Institute|