Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020865
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2001-07-11
Brief Title:
Levofloxacin Compared With Cefepime in Treating Cancer Patients With Fever and Neutropenia
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 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
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
Detailed Description:
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 500mm3 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G01-1965 | None | None | None |
| UCLA-0006093 | None | None | None |
| MCNEIL-CAPSS-118 | None | None | None |