Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment
This study is no longer recruiting patients.
|Sponsored by:||National Cancer Institute (NCI)
Memorial Sloan-Kettering Cancer Center
|Information provided by:||National Cancer Institute (NCI)|
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.
|Condition||Treatment or Intervention||Phase|
ovarian epithelial cancer
| Procedure: supportive care
Drug: infection prophylaxis/management
Behavior: supportive care/therapy
Procedure: antifungal therapy
Drug: amphotericin B liposomal
Drug: caspofungin acetate
MedlinePlus related topics: Breast Cancer; Eye Cancer; Kidney Cancer; Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphoma; Multiple Myeloma; Ovarian Cancer; Testicular Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Educational/Counseling/Training
Official Title: Phase III Randomized Study of Caspofungin Acetate Versus Amphotericin B Liposomal in Patients With Persistent Fever and Neutropenia Following Treatment for Cancer
Study start: August 2000
OBJECTIVES: I. 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. II. Compare the incidence of nephrotoxicity in patients treated with these regimens. III. Compare the incidence of infusion-related adverse events within 1 hour of the infusion in patients treated with these regimens. IV. 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. V. Compare incidence of required dose increase due to inadequate clinical response in patients treated with these regimens. VI. Compare the time to resolution of fever in patients treated with these regimens.
PROTOCOL 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.
Ages Eligible for Study: 16 Years and above
PROTOCOL ENTRY CRITERIA:
Clinical trial summary from the National Cancer Institute's PDQ® database
Walsh TJ, Teppler H, Donowitz GR, Maertens JA, Baden LR, Dmoszynska A, Cornely OA, Bourque MR, Lupinacci RJ, Sable CA, dePauw BE. Caspofungin versus liposomal amphotericin B for empirical antifungal therapy in patients with persistent fever and neutropenia. N Engl J Med. 2004 Sep 30;351(14):1391-402.
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