Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Levofloxacin Compared With Cefepime in Treating Cancer Patients With Fever and Neutropenia

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Closed 18 and over NCI, Pharmaceutical / Industry UCLA-0006093 MCNEIL-CAPSS-118, NCI-G01-1965, NCT00020865

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.
 

Entry Criteria

Disease Characteristics:

Diagnosis of malignancy
 Solid tumor (including lymphoma) or leukemia

Hospitalized and anticipated to remain hospitalized during study

Febrile defined as oral temperature of at least 100.4 degrees F (38 degrees C)
on 2 occasions within 24 hours OR at least 100.8 degrees F (38.2 degrees C) on
a single reading
 No obvious noninfectious cause of fever (e.g., platelet transfusion)

Neutropenic, defined as absolute neutrophil count (ANC) currently less than
500/mm3 OR anticipated to be less than 500/mm3 within 24 hours of study entry
 Anticipated ANC to be less than 500/mm3 for at least 72 hours
 No neutropenia unassociated with malignancy
 No chronic neutropenia
 No neutropenia anticipated to last more than 14 days

No acute myelogenous leukemia unless receiving consolidation chemotherapy or
induction dose that does not prolong neutropenia for more than 3 weeks

No infection due to an identified organism

No high likelihood of infection due to anaerobic organisms, including
intra-abdominal infections or perirectal abscess at admission

No known osteomyelitis

No requirement for new antifungal agent

Prior/Concurrent Therapy:

Biologic therapy:
 No prior sargramostim (GM-CSF) or filgrastim (G-CSF) for current course of
  chemotherapy
 Concurrent GM-CSF or G-CSF allowed if neutropenia lasts at least 3 days

Chemotherapy:
 See Disease Characteristics

Endocrine therapy:
 Not specified

Radiotherapy:
 Not specified

Surgery:
 Not specified

Other:
 No prior treatment under this protocol
 No prior prophylactic anti-infectives other than acyclovir or
  sulfamethoxazole with trimethoprim
 At least 72 hours since prior systemic antibiotics (except prophylactic
  sulfamethoxazole with trimethoprim)
 At least 30 days since prior experimental drug or medical device (except
  drugs currently marketed in the United States for the treatment of the
  malignancy)
 No other concurrent systemic antibacterial agents
 No concurrent topical antimicrobial agents

Patient Characteristics:

Age:
 18 and over

Performance status:
 Not specified

Life expectancy:
 At least 14 days

Hematopoietic:
 See Disease Characteristics

Hepatic:
 Not specified

Renal:
 Creatinine clearance at least 20 mL/min
 No oliguria (urine output less than 20 mL/hour) unresponsive to fluid
  challenge

Cardiovascular:
 No shock or hypotension (supine systolic blood pressure less than 80 mmHg)
  unresponsive to fluid challenge

Other:
 Not pregnant or nursing
 Negative pregnancy test
 Fertile patients must use effective contraception
 No HIV infection with CD4 counts less than 200/mm3
 No significant risk for seizures
 No unstable psychiatric disorder
 Weight greater than 40 kg
 No prior allergic or severe adverse reaction to study drugs or to any member
  of the quinolone or beta-lactam class of antibacterials
 No disorder or disease that would preclude study

Expected Enrollment

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.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Mary Territo, MD, Protocol chair		Ph: 310-825-7768; 888-798-0719

Registry Information
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
Trial Start Date		2001-09-10
Registered in ClinicalTrials.gov		NCT00020865
Date Submitted to PDQ		2001-05-08
Information Last Verified		2007-05-23
NCI Grant/Contract Number		CA16042

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