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

Phase 2TerminatedNCT00238355

OHSU Knight Cancer Institute13 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Infection Unspecified Adult Solid Tumor, Protocol Specific

Interventions

caspofungin acetateDRUG

70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84.

voriconazoleDRUG

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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)

Locations (1)

OHSU Knight Cancer Institute

Portland, Oregon, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks after starting treatment

Secondary Outcomes

Survival at 12 Weeks

Defined as the number of evaluable subjects alive at 12 weeks (84 days) following registration.

Time frame: up to 12 weeks

Data from ClinicalTrials.gov

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