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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003938
• Other study ID #: EORTC-19951
• Secondary ID: EORTC-19951
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: September 20, 2012
• Start date: June 1999

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Hematologic malignancy or solid tumor

• Must be undergoing remission induction and/or consolidation therapy for hematologic malignancy only OR

• Must be undergoing allogeneic or autologous bone marrow transplantation

• Granulocyte count less than 500/mm^3 and profound granulocytopenia expected to last for greater than 5 days

• Fever (greater than 38.5 degrees C) refractory for greater than 72 hours and less than 84 hours to broad spectrum antimicrobials, after exclusion of current bacterial, fungal, viral, parasitic, and mycobacterial infections

• Peripheral blood cultures and central venous catheter cultures negative for infections

• 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

Study Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• liposomal amphotericin B

Locations

Country	Name	City	State
Belgium	A.Z. St. Jan	Brugge
Belgium	Hopital Universitaire Erasme	Brussels
Belgium	Institut Jules Bordet	Brussels
Belgium	U.Z. Gasthuisberg	Leuven
Belgium	Clinique Universitaire De Mont-Godinne	Mont-Godinne Yvoir
Czech Republic	University Hospital - Olomouc	Olomouc
France	CHU de Caen	Caen
France	Centre Hospitalier Universitaire Henri Mondor	Creteil
France	Hopital Saint-Louis	Paris
Germany	Universitaetsklinikum Charite	Berlin
Germany	Virchow Klinikum Humboldt Universitaet Berlin	Berlin
Greece	Athens University-Laikon General Hospital	Athens
Greece	Hippokration Hospital	Thessaloniki
Hungary	Szent Laszlo Korhaz	Budapest
Israel	Hadassah University Hospital	Jerusalem
Italy	Istituto Nazionale per la Ricerca sul Cancro	Genoa (Genova)
Netherlands	University Medical Center Nijmegen	Nijmegen
Portugal	Hospital De Santo Antonio Dos Capuchos	Lisbon (Lisboa)
Slovakia	National Cancer Institute - Bratislava	Bratislava
Spain	Hospital de la Santa Cruz I Sant Pau	Barcelona
Spain	Hospital Central de Asturias	Oviedo
Sweden	Huddinge University Hospital	Stockholm
Turkey	Section of Infectious Diseases	Ankara
United Arab Emirates	Tawam Hospital	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Czech Republic,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Netherlands,  Portugal,  Slovakia,  Spain,  Sweden,  Turkey,  United Arab Emirates,