OBJECTIVES:
- Compare the number of successful treatment outcomes among patients treated with caspofungin acetate vs amphotericin B liposomal for persistent fever and neutropenia following cancer therapy, in terms of survival for 7 days after study drug, resolution of fever, treatment of any baseline fungal infection, absence of breakthrough fungal infection during and for 7 days after study drug, and absence of study drug discontinuation due to toxicity or lack of efficacy.
- Compare the incidence of nephrotoxicity in patients treated with these regimens.
- Compare the incidence of infusion-related adverse events within 1 hour of the infusion in patients treated with these regimens.
- Compare the incidence of treatment discontinuation due to drug-related adverse events, frequency of drug-related events, number of breakthrough fungal infections, and number of successfully treated baseline fungal infections in patients treated with these regimens.
- Compare incidence of required dose increase due to inadequate clinical response in patients treated with these regimens.
- Compare the time to resolution of fever in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to high-risk (prior allogeneic bone marrow transplantation or prior chemotherapy for relapse of acute leukemia) vs low-risk and prior prophylactic antifungal therapy during chemotherapy (yes vs no). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive caspofungin acetate IV over 1 hour followed by placebo IV over 2 hours.
- Arm II: Patients receive placebo IV over 1 hour followed by amphotericin B liposomal IV over 2 hours.
Treatment repeats daily for up to 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 7 and 14 days after study drug discontinuation.
PROJECTED ACCRUAL: A total of 1060 patients (530 per arm) will be accrued for this study.
