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

Phase 3

Completed

• Conditions: Cancer

• Registration Number: NCT00003938
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief 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.

Study Timeline

• Study Start: 1999-06
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2003-05
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-20
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (24)

A.Z. St. Jan; 🇧🇪 Brugge, 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, Czech Republic

CHU de Caen; 🇫🇷 Caen, France

Hopital Saint-Louis; 🇫🇷 Paris, France

Centre Hospitalier Universitaire Henri Mondor; 🇫🇷 Creteil, France

Universitaetsklinikum Charite; 🇩🇪 Berlin, Germany

Athens University-Laikon General Hospital; 🇬🇷 Athens, Greece

Virchow Klinikum Humboldt Universitaet Berlin; 🇩🇪 Berlin, Germany

Szent Laszlo Korhaz; 🇭🇺 Budapest, Hungary

Hippokration Hospital; 🇬🇷 Thessaloniki, Greece

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

Section of Infectious Diseases; 🇹🇷 Ankara, Turkey

Tawam Hospital; 🇦🇪 Abu Dhabi, United Arab Emirates

Huddinge University Hospital; 🇸🇪 Stockholm, Sweden