Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer
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.
|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|
|Study Design:||Allocation: Randomized
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)|
- Response as measured by International Antimicrobial Therapy Group (IATG) specific criteria at the completion of allocated treatment
- 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
|Study Start Date:||April 2002|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062231
|Hopital Universitaire Erasme|
|Brussels, Belgium, 1070|
|Cliniques Universitaires Saint-Luc|
|Brussels, Belgium, 1200|
|Leuven, Belgium, B-3000|
|Bordeaux, France, 33076|
|Institut Curie Hopital|
|Paris, France, 75248|
|Charite - Campus Charite Mitte|
|Berlin, Germany, D-10117|
|Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin|
|Berlin, Germany, D-12200|
|Medizinische Universitaetsklinik I at the University of Cologne|
|Cologne, Germany, D-50924|
|Klinikum der Albert - Ludwigs - Universitaet Freiburg|
|Freiburg, Germany, D-79106|
|Ruprecht - Karls - Universitaet Heidelberg|
|Heidelberg, Germany, D-69117|
|Klinikum der Stadt Mannheim|
|Mannheim, Germany, D-68135|
|Frauenklinik - Universitaetsklinikum Rostock am Klinikum Sudstadt|
|Rostock, Germany, D-18057|
|Ulm, Germany, D-89081|
|Wolfson Medical Center|
|Holon, Israel, 58100|
|Istituto Nazionale per la Ricerca sul Cancro|
|Genoa, Italy, 16132|
|Universita Degli Studi di Udine|
|Udine, Italy, 33100|
|National Cancer Institute - Bratislava|
|Bratislava, Slovakia, 833 10|
|St. Elizabeth Cancer Institute Hospital|
|Bratislava, Slovakia, SK-81250|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Yverdon, Switzerland, CH-1400|
|Hacettepe University - Faculty of Medicine|
|Ankara, Turkey, 06100|
|Ibn-i Sina Hospital|
|Ankara, Turkey, 06100|
|Marmara University Hospital|
|Istanbul, Turkey, 81190|
|Study Chair:||Winfried Kern, MD||University Hospital Freiburg|