Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-26 @ 9:14 AM
Study NCT ID:
NCT00008359
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2001-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
* 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: