Levofloxacin Compared With Cefepime in Treating Cancer Patients With Fever and Neutropenia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00020865|
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : March 17, 2004
Last Update Posted : December 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Fever, Sweats, and Hot Flashes Infection Leukemia Lymphoma Neutropenia Unspecified Adult Solid Tumor, Protocol Specific||Drug: cefepime hydrochloride Drug: levofloxacin||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Primary Purpose:||Supportive Care|
|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|
|Study Start Date :||September 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020865
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|Study Chair:||Mary C. Territo, MD||Jonsson Comprehensive Cancer Center|