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Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer

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. Identifier: NCT00062231
Recruitment Status : Terminated (low accrual)
First Posted : June 6, 2003
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

RATIONALE: Antibiotics such as amoxicillin, ciprofloxacin, and moxifloxacin may be effective in preventing or controlling fever and neutropenia in patients with cancer. It is not yet known whether moxifloxacin alone is more effective than amoxicillin combined with ciprofloxacin in treating neutropenia and fever.

PURPOSE: This randomized clinical trial is studying how well moxifloxacin works and compares it to ciprofloxacin together with amoxicillin in treating neutropenia and fever in patients with cancer.

Condition or disease Intervention/treatment Phase
Chronic Myeloproliferative Disorders Fever, Sweats, and Hot Flashes Infection Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Neutropenia Precancerous Condition Unspecified Adult Solid Tumor, Protocol Specific Drug: amoxicillin-clavulanate potassium Drug: ciprofloxacin Drug: moxifloxacin hydrochloride Procedure: management of therapy complications Not Applicable

Detailed Description:


  • Compare the rates of successful response to moxifloxacin vs ciprofloxacin in combination with amoxicillin-clavulanate potassium in low-risk febrile neutropenic patients with cancer.
  • Compare the time to discharge, time to discontinuation of any antimicrobial therapy, and time to defervescence of patients treated with these regimens.
  • Compare 28-day survival of patients treated with these regimens.
  • Determine the proportion of these patients who are eligible for oral therapy and a therapeutic management including intention of early discharge.
  • Determine the medical and nonmedical reasons for continued in-hospital observation and care or for readmission of these patients.
  • Determine the accuracy of the physician's estimate of further neutropenia duration and evaluate its predictive value in these patients.
  • Validate the Multinational Association for Supportive Care in Cancer low-risk prediction rule to predict the absence of serious medical complications in the setting of oral therapy in in- and outpatients.

OUTLINE: This is a double-blind, randomized, multicenter study. Patients are stratified according to institution, underlying disease (hematologic malignancy vs other), pretreatment with no more than a single dose (yes vs no), and outpatient status at fever onset (yes vs no). Patients are randomized into 1 of 2 treatment arms.

  • Arm I: Patients receive oral moxifloxacin once daily. Patients also receive oral ciprofloxacin placebo and oral amoxicillin-clavulanate potassium placebo twice daily.
  • Arm II: Patients receive oral ciprofloxacin and oral amoxicillin-clavulanate potassium twice daily. Patients also receive oral moxifloxacin placebo once daily.

Patients with fever classified as not related to infection (i.e., doubtful) stop antibiotic therapy on day 3. All other patients receive antibiotics until complete resolution of infection, or until failure is determined or anticipated, for up to 28 days.

Patients are followed at 7-10 days.

PROJECTED ACCRUAL: A total of 530 patients (265 patients per treatment arm) will be accrued for this study within approximately 2 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 351 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
Official Title: Oral Empirical Therapy of Fever in Low-Risk Neutropenic Cancer Patients: A Prospective, Double-Blind, Randomized, Multicenter Trial Comparing Monotherapy (Single Daily Dose Moxifloxacin) With Combination Therapy (Ciprofloxacin Plus Amoxicillin/Clavulanic Acid)
Study Start Date : April 2002
Actual Primary Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
Genetic and Rare Diseases Information Center resources: Lymphosarcoma B-cell Lymphoma Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Follicular Lymphoma Chronic Lymphocytic Leukemia Multiple Myeloma Mantle Cell Lymphoma Myelodysplastic Syndromes Primary Myelofibrosis Chronic Myeloproliferative Disorders Polycythemia Vera Cutaneous T-cell Lymphoma Granulocytopenia Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Diffuse Large B-Cell Lymphoma Leukemia, T-cell, Chronic Adult T-cell Leukemia/lymphoma Waldenstrom Macroglobulinemia Monoclonal Gammopathy of Undetermined Significance Mycosis Fungoides Hodgkin Lymphoma Hairy Cell Leukemia Marginal Zone Lymphoma Essential Thrombocythemia Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Sezary Syndrome Plasmacytoma AL Amyloidosis Myelodysplastic/myeloproliferative Disease Burkitt Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Chronic Neutrophilic Leukemia Aggressive NK Cell Leukemia T-cell Large Granular Lymphocyte Leukemia

Primary Outcome Measures :
  1. Response as measured by International Antimicrobial Therapy Group (IATG) specific criteria at the completion of allocated treatment

Secondary Outcome Measures :
  1. Rate of complication as measured by Multinational Association for Supportive Care in Cancer (MASCC) criteria at the end of febrile neutropenic episode
  2. Time to discharge as measured by Logrank continuously until the end of febrile neutropenic episode
  3. Time to defervescence as measured by Logrank continuously until the end of febrile neutropenic episode
  4. Survival status as measured by Logrank at day 28

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of cancer with developing febrile neutropenia

    • Neutropenia defined as an absolute granulocyte count of less than 1,000/mm^3, expected to fall to less than 500/mm^3 within 24 hours, secondary to administration of chemotherapy and/or radiotherapy within the past 30 days
    • Fever defined as an oral temperature greater than 38.5ºC once, or 38°C or greater on 2 or more occasions at least 1 hour apart during a 12-hour period, and suspected to be due to infection
  • Expected low risk of serious medical complications as predicted by a Multinational Association for Supportive Care in Cancer risk-index score of greater than 20
  • No obvious signs of exit-site or tunnel intravascular catheter infection
  • No known or suspected CNS infection
  • No known or highly suspected bacterial, viral, or fungal infection



  • 18 and over

Performance status

  • Not specified

Life expectancy

  • No high probability of death within 48 hours before study enrollment (i.e., patients who are moribund or comatose for any reason with little hope of recovery OR patients in danger of, or in hepatic stupor or coma)


  • See Disease Characteristics
  • No signs or symptoms of uncontrolled bleeding


  • Bilirubin no greater than 3 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 3 times ULN
  • AST and ALT no greater than 5 times ULN
  • No severe hepatic dysfunction


  • Creatinine no greater than 3.4 mg/dL
  • Creatinine clearance at least 25 mL/min
  • No renal failure requiring hemodialysis or peritoneal dialysis


  • No prior symptomatic arrhythmias
  • No clinically relevant bradycardia
  • No QTc interval prolongation
  • No uncorrected hypokalemia
  • No signs or symptoms of hypotension (systolic less than 90 mm Hg)


  • No signs or symptoms of respiratory insufficiency


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Able to swallow oral medication
  • No contraindication for oral drug intake
  • No condition likely to severely impair drug absorption
  • No prior immediate or accelerated reaction to penicillin, cephalosporin, or fluoroquinolone antibiotics
  • No known allergy or hypersensitivity to any antibiotics in this study or other quinolones
  • No signs or symptoms of severe dehydration
  • No signs or symptoms of shock
  • No other signs or symptoms at presentation that would necessitate IV supportive therapy


Biologic therapy

  • Not specified


  • See Disease Characteristics

Endocrine therapy

  • Not specified


  • See Disease Characteristics


  • Not specified


  • More than 4 days since prior antibacterial agents except for the following:

    • A single (oral or parenteral therapeutic) dose after initial diagnosic work-up and within the last 8 hours
    • Low-dose cotrimoxazole (i.e., no more than 480 mg daily or 960 mg 3 times per week) prophylaxis of Pneumocystis carinii pneumonia
  • More than 30 days since prior investigational drugs
  • No prior randomization in this study
  • No other concurrent antimicrobial agents
  • No class IA or class III antiarrhythmic drugs or other concurrent drugs that prolong the QTc interval

Information from the National Library of Medicine

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 identifier (NCT number): NCT00062231

Show Show 23 study locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Winfried Kern, MD University Hospital Freiburg
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00062231    
Other Study ID Numbers: EORTC-46001
First Posted: June 6, 2003    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
fever, sweats, and hot flashes
unspecified adult solid tumor, protocol specific
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
monoclonal gammopathy of undetermined significance
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
isolated plasmacytoma of bone
extramedullary plasmacytoma
refractory multiple myeloma
stage 0 chronic lymphocytic leukemia
Waldenstrom macroglobulinemia
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Precancerous Conditions
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Hot Flashes
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Body Temperature Changes