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

Study Overview
=================
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.

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

Conditions
-----------------
Infection, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
-----------------
* Drug: caspofungin acetate
* Drug: voriconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of probable or definite invasive fungal infection with 1 of the following organisms: Aspergillus species Fusarium species Scedosporium species (Pseudallescheria boydii) Other dematiaceous molds The following diagnosis are not allowed: Zygomycetes (Mucor or Rhizopus species) Chronic aspergillosis Aspergilloma Allergic bronchopulmonary aspergillosis Must be immunocompromised PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy At least 72 hours Hematopoietic Not specified Hepatic AST < 5 times upper limit of normal (ULN) Bilirubin < 5 times ULN Alkaline phosphatase < 5 times ULN No Child-Pugh class C cirrhosis Renal Creatinine clearance ≥ 50 mL/min Pulmonary No mechanical ventilation Other Not pregnant or nursing Fertile patients must use effective contraception No hypersensitivity to azoles, caspofungin acetate, or their components No history of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other More than 14 days since prior therapeutic antifungal therapy of ≥ 1 week duration More than 14 days since prior and no concurrent administration of any of the following medications: Terfenadine Astemizole Cisapride Pimozide Quinidine Sirolimus Rifampin Carbamazepine Long-acting barbiturates Rifabutin Ergot alkaloids (i.e., ergotamine and dihydroergotamine)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Voriconazole plus Caspofungin<br> | Drug: caspofungin acetate<br>* 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84.<br>Drug: voriconazole<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Survival up to 12 Weeks |  | up to 12 weeks | 
| Safety |  | duration of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infection, unspecified adult solid tumor, protocol specific