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

This study is currently recruiting patients.

Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)

Purpose

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: Randomized clinical trial to compare the effectiveness of moxifloxacin with that of ciprofloxacin combined with amoxicillin in treating neutropenia and fever in patients who have cancer.

Condition Treatment or Intervention
adult solid tumor
fever, sweats, and hot flashes
hematopoietic and lymphoid cancer
Infection
Neutropenia
 Drug: amoxicillin-clavulanate potassium
 Drug: ciprofloxacin
 Drug: moxifloxacin
 Procedure: antibiotic therapy
 Procedure: complications of therapy assessment/management
 Procedure: infection prophylaxis/management
 Procedure: supportive care/therapy

MedlinePlus related topics:  Blood and Blood Disorders

Study Type: Interventional
Study Design: Treatment

Official Title: Randomized Study of Moxifloxacin Versus Ciprofloxacin in Combination With Amoxicillin-Clavulanate Potassium in Low-Risk Febrile Neutropenic Patients With Cancer

Further Study Details: 

OBJECTIVES:

  • 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.

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS: Age

  • 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)

Hematopoietic

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

Hepatic

  • 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

Renal

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

Cardiovascular

  • 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)

Pulmonary

  • No signs or symptoms of respiratory insufficiency

Other

  • 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

PRIOR CONCURRENT THERAPY: Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics

Surgery

  • Not specified

Other

  • 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

Location and Contact Information


Belgium
      Cliniques Universitaires Saint-Luc, Brussels,  1200,  Belgium; Recruiting
Contact Person  32-2-764-2066 

      Hopital Universitaire Erasme, Brussels,  1070,  Belgium; Recruiting
Contact Person  32-2-555-3806 

      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium; Recruiting
Contact Person  32-16-34-6900 

France
      Institut Bergonie, Bordeaux,  33076,  France; Recruiting
Contact Person  33-556-333-333 

      Institut Curie - Section Medicale, Paris,  75248,  France; Recruiting
Contact Person  33-44-32-4100 

Germany
      Charite - Campus Charite Mitte, Berlin,  D-10117,  Germany; Recruiting
Contact Person  49-30-450-513-002 

      Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin,  D-12200,  Germany; Recruiting
Contact Person  49-30-8445-0 

      Frauenklinik - Universitaetsklinikum Rostock, Rostock,  D-18057,  Germany; Recruiting
Contact Person  49-381-494-8101 

      Klinikum der Albert - Ludwigs - Universitaet Freiburg, Freiburg,  D-79106,  Germany; Recruiting
Contact Person  49-761-270-1818 

      Klinikum der Stadt Mannheim, Mannheim,  D-68135,  Germany; Recruiting
Contact Person  49-621-383-3833 

      Medizinische Universitaetsklinik I, Cologne,  D-50924,  Germany; Recruiting
Contact Person  49-221-478-4400 

      Ruprecht - Karls - Universitaet Heidelberg, Heidelberg,  D-69117,  Germany; Recruiting
Contact Person  49-6221-568-011 

      Universitaetsklinikum Ulm, Ulm,  D-89081,  Germany; Recruiting
Contact Person  49-731-5002-33-33 

Israel
      Wolfson Medical Center, Holon,  58100,  Israel; Recruiting
Contact Person  972-3-502-8211 

Italy
      Istituto Nazionale per la Ricerca sul Cancro, Genoa,  16132,  Italy; Recruiting
Contact Person  39-10-56-001 

      Universita Degli Studi di Udine, Udine,  33100,  Italy; Recruiting
Contact Person  39-0432-552-200 

Slovakia
      National Cancer Institute - Bratislava, Bratislava,  833 10,  Slovakia; Recruiting
Contact Person  421-7-5477-2362 

      St. Elizabeth Cancer Institute Hospital, Bratislava,  SK-81250,  Slovakia; Recruiting
Contact Person  421-2-5924-9272 

Switzerland
      Centre Hospitalier Universitaire Vaudois, Lausanne,  CH-1011,  Switzerland; Recruiting
Contact Person  41-21-314-0150 

      Hopital D'Yverdon, Yverdon,  CH-1400,  Switzerland; Recruiting
Contact Person  41-24-424-4444 

Turkey
      Hacettepe University - Faculty of Medicine, Ankara,  06100,  Turkey; Recruiting
Contact Person  90-312-305-1080 

      Ibn-i Sina Hospital, Ankara,  06100,  Turkey; Recruiting
Contact Person  90-312-310-3333 

      Marmara University Hospital, Istanbul,  81190,  Turkey; Recruiting
Contact Person  90-216-327-4142 

Study chairs or principal investigators

Winfried Kern, MD,  Klinikum der Albert - Ludwigs - Universitaet Freiburg   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000304631; EORTC-46001; NCT00062231
Record last reviewed:  March 2005
Last Updated:  March 15, 2005
Record first received:  June 5, 2003
ClinicalTrials.gov Identifier:  NCT00062231
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005