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| Sponsor: | 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 Condition Unspecified Adult Solid Tumor, Protocol Specific |
Drug: amoxicillin-clavulanate potassium Drug: ciprofloxacin Drug: moxifloxacin hydrochloride Procedure: management of therapy complications |
| 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 | |
| Investigator: | Winfried Kern, MD | University Hospital Freiburg |
More Information
| Study ID Numbers: | CDR0000304631, EORTC-46001 |
| Study First Received: | June 5, 2003 |
| Last Updated: | February 1, 2010 |
| ClinicalTrials.gov Identifier: | NCT00062231 History of Changes |
| Health Authority: | United States: Federal Government |
|
infection neutropenia 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 |
|
Communicable Diseases Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Hot Flashes Leukocyte Disorders Preleukemia Hemorrhagic Disorders Pathologic Processes Therapeutic Uses Cardiovascular Diseases Nucleic Acid Synthesis Inhibitors Amoxicillin Immunoproliferative Disorders Immune System Diseases Hematologic Diseases |
Myeloproliferative Disorders Multiple Myeloma Neutropenia Neoplasms Lymphoma, Non-Hodgkin Leukopenia Precancerous Conditions Blood Protein Disorders Paraproteinemias Body Temperature Changes Infection Hemostatic Disorders Fever Signs and Symptoms Leukemia |