Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients
NCT ID: NCT00003938
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
115 participants
INTERVENTIONAL
1999-06-30
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of liposomal amphotericin B in treating granulocytopenia and fever in cancer patients.
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Detailed Description
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* Compare the efficacy and side effects of amphotericin B-liposomal formulation initiated 72-84 hours vs 144-156 hours after onset of a febrile episode in cancer patients with granulocytopenia and persistent unexplained fever refractory to antibacterials.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to antifungal prophylaxis (yes vs no) and type of underlying condition. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive amphotericin B-liposomal formulation IV over 1 hour on day 3 of febrile neutropenia.
* Arm II: Patients receive amphotericin B-liposomal formulation IV over 1 hour on day 6 of febrile neutropenia.
Treatment continues until signs and symptoms of the fungal infection appear or febrile neutropenia has resolved. Persistently neutropenic patients receive treatment for at least 10 days or until another cause of infection is determined.
Patients are followed weekly for 3 weeks.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.
Conditions
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
Interventions
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liposomal amphotericin B
Eligibility Criteria
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Exclusion Criteria
* No microbiological documentation of a bacterial infection (e.g., abscess at catheter site)
* No invasive fungal infection
* No probable noninfectious cause of fever
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* Karnofsky 40-100% OR
* WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No prior anaphylactic reaction to amphotericin B
* No psychological, familial, sociological, or geographical conditions that would prevent compliance
* Not pregnant or nursing
* Normal chest X-ray or normal high resolution CT scan of the lungs
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* See Disease Characteristics
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No concurrent active systemic antifungal agents or antifungal prophylaxis (e.g., azoles or polyenes)
* No prior IV amphotericin B during same neutropenic episode
* No change in antibacterial regimen within 48 hours prior to study
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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P. Ljungman, MD
Role: STUDY_CHAIR
Karolinska Institutet
Locations
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A.Z. St. Jan
Bruges, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Hopital Universitaire Erasme
Brussels, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Clinique Universitaire De Mont-Godinne
Mont-Godinne Yvoir, , Belgium
University Hospital - Olomouc
Olomouc, , Czechia
CHU de Caen
Caen, , France
Centre Hospitalier Universitaire Henri Mondor
Créteil, , France
Hopital Saint-Louis
Paris, , France
Universitaetsklinikum Charite
Berlin, , Germany
Virchow Klinikum Humboldt Universitaet Berlin
Berlin, , Germany
Athens University-Laikon General Hospital
Athens, , Greece
Hippokration Hospital
Thessaloniki, , Greece
Szent Laszlo Korhaz
Budapest, , Hungary
Hadassah University Hospital
Jerusalem, , Israel
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), , Italy
University Medical Center Nijmegen
Nijmegen, , Netherlands
Hospital De Santo Antonio Dos Capuchos
Lisbon (Lisboa), , Portugal
National Cancer Institute - Bratislava
Bratislava, , Slovakia
Hospital de la Santa Cruz I Sant Pau
Barcelona, , Spain
Hospital Central de Asturias
Oviedo, , Spain
Huddinge University Hospital
Stockholm, , Sweden
Section of Infectious Diseases
Ankara, , Turkey (Türkiye)
Tawam Hospital
Abu Dhabi, , United Arab Emirates
Countries
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Other Identifiers
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EORTC-19951
Identifier Type: -
Identifier Source: secondary_id
EORTC-19951
Identifier Type: -
Identifier Source: org_study_id
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