Lymphoma Clinical Trial
Official title:
Multicenter, Double-Blind, Randomized Study to Compare the Safety and Efficacy of Levofloxacin With That of Cefepime in the Treatment of Fever and Neutropenia - Phase IIIB
RATIONALE: Levofloxacin may be effective in reducing fever and controlling other symptoms of
neutropenia in patients who are being treated for cancer. It is not yet known whether
levofloxacin is more effective than cefepime in reducing fever and controlling symptoms of
neutropenia.
PURPOSE: Randomized phase III trial to compare the effectiveness of levofloxacin with that
of cefepime in reducing fever and controlling symptoms of neutropenia in patients who are
being treated for cancer.
OBJECTIVES: I. Compare the safety and efficacy of levofloxacin versus cefepime in cancer
patients with fever and neutropenia. II. Compare the percentage of patients whose fever
defervesces and who have no signs or symptoms of infection with and without therapeutic
modification. III. Compare the percentage of survival of patients treated with these 2
regimens with no therapeutic modifications. IV. Compare the overall survival of patients
treated with these 2 regimens regardless of therapeutic modifications. V. Compare the time
to resolution of fever in patients treated with these regimens. VI. Compare the
microbiologic response by pathogen and site of infection in patients treated with these
regimens. VII. Compare the percentage of patients whose fever defervesces only after
resolution of neutropenia (absolute neutrophil count at least 500/mm3) with no therapeutic
modification.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified
according to type of malignancy (solid tumor, including lymphoma vs leukemia), prior
prophylactic antibiotics (yes vs no), and participating center. Patients are randomized to
one of two treatment arms. Arm I: Patients receive levofloxacin IV over 90 minutes once
daily for 14-28 days. Arm II: Patients receive cefepime IV over 30 minutes every 8 hours for
14-28 days. Patients may receive additional antifungal, antibacterial, or antiviral therapy
if condition has deteriorated, no response is seen in 72 hours, or and infection is
suspected or documented. Patients are followed at 1-3 and 7-12 days and then at 3-4 weeks.
PROJECTED ACCRUAL: Approximately 260-400 patients (130-200 per treatment arm) will be
accrued for this study.
;
Primary Purpose: Supportive Care
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