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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00020865
First received: July 11, 2001
Last updated: December 18, 2013
Last verified: May 2007
  Purpose

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 Intervention Phase
Fever, Sweats, and Hot Flashes
Infection
Leukemia
Lymphoma
Neutropenia
Unspecified Adult Solid Tumor, Protocol Specific
Drug: cefepime hydrochloride
Drug: levofloxacin
Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2001
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020865

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Mary C. Territo, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00020865     History of Changes
Other Study ID Numbers: CDR0000068726, UCLA-0006093, MCNEIL-CAPSS-118, NCI-G01-1965
Study First Received: July 11, 2001
Last Updated: December 18, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent adult Hodgkin lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
stage 0 chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
unspecified adult solid tumor, protocol specific
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
fever, sweats, and hot flashes
progressive hairy cell leukemia, initial treatment
refractory hairy cell leukemia
stage I grade 1 follicular lymphoma

Additional relevant MeSH terms:
Fever
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Neutropenia
Lymphoma, Large-Cell, Immunoblastic
Hot Flashes
Body Temperature Changes
Signs and Symptoms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Levofloxacin
Ofloxacin
Cefepime
Cephalosporins
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014