Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients
RATIONALE: Liposomal amphotericin B may be effective in controlling fever and granulocytopenia. It is not yet known which regimen of liposomal amphotericin B is more effective in treating cancer patients who have these conditions.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of liposomal amphotericin B in treating granulocytopenia and fever in cancer patients.
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||A Strategic Study to Determine the Optimal Moment to Initiate Systemic Antifungal Therapy With Ambisome in Granulocytopenic Cancer Patients With Unexplained Fever Refractory to Empirical Antibacterials|
|Study Start Date:||June 1999|
|Primary Completion Date:||May 2003 (Final data collection date for primary outcome measure)|
- 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.
Hide Study Locations
|A.Z. St. Jan|
|Brugge, Belgium, 8000|
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|Hopital Universitaire Erasme|
|Brussels, Belgium, 1070|
|Leuven, Belgium, B-3000|
|Clinique Universitaire De Mont-Godinne|
|Mont-Godinne Yvoir, Belgium, 5530|
|University Hospital - Olomouc|
|Olomouc, Czech Republic, 775 20|
|CHU de Caen|
|Caen, France, 14033|
|Centre Hospitalier Universitaire Henri Mondor|
|Creteil, France, 94010|
|Paris, France, 75475|
|Berlin, Germany, D-10117|
|Virchow Klinikum Humboldt Universitaet Berlin|
|Berlin, Germany, D-13353|
|Athens University-Laikon General Hospital|
|Athens, Greece, 11527|
|Thessaloniki, Greece, 54642|
|Szent Laszlo Korhaz|
|Budapest, Hungary, 1097|
|Hadassah University Hospital|
|Jerusalem, Israel, 91120|
|Istituto Nazionale per la Ricerca sul Cancro|
|Genoa (Genova), Italy, 16132|
|University Medical Center Nijmegen|
|Nijmegen, Netherlands, NL-6500 HB|
|Hospital De Santo Antonio Dos Capuchos|
|Lisbon (Lisboa), Portugal, 1100|
|National Cancer Institute - Bratislava|
|Bratislava, Slovakia, 812 50|
|Hospital de la Santa Cruz I Sant Pau|
|Barcelona, Spain, 08025|
|Hospital Central de Asturias|
|Oviedo, Spain, 33006|
|Huddinge University Hospital|
|Stockholm, Sweden, SE-141 86|
|Section of Infectious Diseases|
|Ankara, Turkey, 06100|
|United Arab Emirates|
|Abu Dhabi, United Arab Emirates|
|Study Chair:||P. Ljungman, MD||Karolinska Institutet|