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

Phase 2

Terminated

• Conditions: Infection; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Drug: caspofungin acetate; Drug: voriconazole

• Registration Number: NCT00238355
• Lead Sponsor: OHSU Knight Cancer Institute

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.

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.

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2005-10-12
• Study First Submitted QC: 2005-10-12
• Study First Posted: 2005-10-13
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2011-11-07
• Results First Submitted QC: 2011-11-07
• Status Verified: 2011-12
• Results First Posted: 2011-12-09
• Last Update Submitted: 2011-12-12
• Last Update Posted: 2011-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Voriconazole plus Caspofungin	caspofungin acetate	-
Voriconazole plus Caspofungin	voriconazole	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Complete or Partial Response Rate to the Combination of Voriconazole and Caspofungin at 12 Weeks.	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Survival up to 12 Weeks	up to 12 weeks
Safety	duration of study

Trial Locations

Locations (1)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States