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

Not Applicable

Terminated

• Conditions: 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

• Registration Number: NCT00062231
• Lead Sponsor: 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.

Detailed Description

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.

* 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.

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2003-06-05
• Study First Submitted QC: 2003-06-05
• Study First Posted: 2003-06-06
• Primary Completion: 2006-10
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-20
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 351

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response as measured by International Antimicrobial Therapy Group (IATG) specific criteria at the completion of allocated treatment

Secondary Outcome Measures

Name	Time	Method
Rate of complication as measured by Multinational Association for Supportive Care in Cancer (MASCC) criteria at the end of febrile neutropenic episode
Time to discharge as measured by Logrank continuously until the end of febrile neutropenic episode
Time to defervescence as measured by Logrank continuously until the end of febrile neutropenic episode
Survival status as measured by Logrank at day 28

Trial Locations

Locations (23)

National Cancer Institute - Bratislava; 🇸🇰 Bratislava, Slovakia

Ibn-i Sina Hospital; 🇹🇷 Ankara, Turkey

Charite - Campus Charite Mitte; 🇩🇪 Berlin, Germany

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Institut Bergonie; 🇫🇷 Bordeaux, France

Institut Curie Hopital; 🇫🇷 Paris, France

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Medizinische Universitaetsklinik I at the University of Cologne; 🇩🇪 Cologne, Germany

Klinikum der Stadt Mannheim; 🇩🇪 Mannheim, Germany

Hopital Universitaire Erasme; 🇧🇪 Brussels, Belgium

Hacettepe University - Faculty of Medicine; 🇹🇷 Ankara, Turkey

Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Universitaetsklinikum Ulm; 🇩🇪 Ulm, Germany

Istituto Nazionale per la Ricerca sul Cancro; 🇮🇹 Genoa, Italy

Marmara University Hospital; 🇹🇷 Istanbul, Turkey

Wolfson Medical Center; 🇮🇱 Holon, Israel

Hopital D'Yverdon; 🇨🇭 Yverdon, Switzerland

Universita Degli Studi di Udine; 🇮🇹 Udine, Italy

St. Elizabeth Cancer Institute Hospital; 🇸🇰 Bratislava, Slovakia

Frauenklinik - Universitaetsklinikum Rostock am Klinikum Sudstadt; 🇩🇪 Rostock, Germany

Ruprecht - Karls - Universitaet Heidelberg; 🇩🇪 Heidelberg, Germany

Klinikum der Albert - Ludwigs - Universitaet Freiburg; 🇩🇪 Freiburg, Germany

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium