NCT00003938

Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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

• Cancer

Interventions

Type	Name	Description
DRUG	liposomal amphotericin B

Timeline

• Start date: 1999-06-01
• Primary completion: 2003-05-01
• First posted: 2003-01-27
• Last updated: 2012-09-24

Locations

24 sites across 15 countries: Belgium, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Portugal, Slovakia, Spain, Sweden, Turkey (Türkiye), United Arab Emirates