Cancer Clinical Trial
Official title:
A Multicenter, Double-Blind, Randomized, Comparative Study To Evaluate The Safety, Tolerability, And Efficacy Of MK-0991 Versus (Amphotericin B) Liposome For Injection As Empirical Therapy In Patients With Persistent Fever And Neutropenia
RATIONALE: Caspofungin acetate or amphotericin B liposomal may be effective in preventing or
controlling fever and neutropenia caused by chemotherapy, bone marrow transplantation, or
peripheral stem cell transplantation. It is not yet known whether caspofungin acetate or
amphotericin B liposomal is more effective for treating these side effects.
PURPOSE: Randomized phase III trial to compare the effectiveness of caspofungin acetate with
that of amphotericin B liposomal in treating patients who have persistent fever and
neutropenia after receiving anticancer therapy.
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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
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