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| Sponsored by: |
European Organization for Research and Treatment of Cancer |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00062231 |
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: 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 | Intervention |
|
Chronic Myeloproliferative Disorders Fever, Sweats, and Hot Flashes Infection Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Neutropenia Precancerous/Nonmalignant Condition Unspecified Adult Solid Tumor, Protocol Specific |
Drug: amoxicillin-clavulanate potassium Drug: ciprofloxacin Drug: moxifloxacin hydrochloride Procedure: management of therapy complications |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Cancer Fever Fungal Infections Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma Sweat |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double-Blind, Active Control |
| 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) |
| Estimated Enrollment: | 530 |
| Study Start Date: | April 2002 |
OBJECTIVES:
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 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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of cancer with developing febrile neutropenia
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
More than 4 days since prior antibacterial agents except for the following:
Contacts and Locations| Belgium | |||||
| Cliniques Universitaires Saint-Luc | |||||
| Brussels, Belgium, 1200 | |||||
| Hopital Universitaire Erasme | |||||
| Brussels, Belgium, 1070 | |||||
| U.Z. Gasthuisberg | |||||
| Leuven, Belgium, B-3000 | |||||
| France | |||||
| Institut Bergonie | |||||
| Bordeaux, France, 33076 | |||||
| Institut Curie Hopital | |||||
| Paris, France, 75248 | |||||
| Germany | |||||
| Medizinische Universitaetsklinik I at the University of Cologne | |||||
| Cologne, Germany, D-50924 | |||||
| Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin | |||||
| Berlin, Germany, D-12200 | |||||
| Frauenklinik - Universitaetsklinikum Rostock am Klinikum Sudstadt | |||||
| Rostock, Germany, D-18057 | |||||
| Klinikum der Albert - Ludwigs - Universitaet Freiburg | |||||
| Freiburg, Germany, D-79106 | |||||
| Klinikum der Stadt Mannheim | |||||
| Mannheim, Germany, D-68135 | |||||
| Charite - Campus Charite Mitte | |||||
| Berlin, Germany, D-10117 | |||||
| Ruprecht - Karls - Universitaet Heidelberg | |||||
| Heidelberg, Germany, D-69117 | |||||
| Universitaetsklinikum Ulm | |||||
| Ulm, Germany, D-89081 | |||||
| Israel | |||||
| Wolfson Medical Center | |||||
| Holon, Israel, 58100 | |||||
| Italy | |||||
| Istituto Nazionale per la Ricerca sul Cancro | |||||
| Genoa, Italy, 16132 | |||||
| Universita Degli Studi di Udine | |||||
| Udine, Italy, 33100 | |||||
| Slovakia | |||||
| National Cancer Institute - Bratislava | |||||
| Bratislava, Slovakia, 833 10 | |||||
| St. Elizabeth Cancer Institute Hospital | |||||
| Bratislava, Slovakia, SK-81250 | |||||
| Switzerland | |||||
| Centre Hospitalier Universitaire Vaudois | |||||
| Lausanne, Switzerland, CH-1011 | |||||
| Hopital D'Yverdon | |||||
| Yverdon, Switzerland, CH-1400 | |||||
| Turkey | |||||
| Hacettepe University - Faculty of Medicine | |||||
| Ankara, Turkey, 06100 | |||||
| Ibn-i Sina Hospital | |||||
| Ankara, Turkey, 06100 | |||||
| Marmara University Hospital | |||||
| Istanbul, Turkey, 81190 | |||||
| European Organization for Research and Treatment of Cancer |
| Investigator: | Winfried Kern, MD | University Hospital Freiburg |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000304631, EORTC-46001 |
| First Received: | June 5, 2003 |
| Last Updated: | August 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00062231 |
| Health Authority: | United States: Federal Government |
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