Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	Not specified	Other	EORTC-19951 NCT00003938

Objectives

1. 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.

Entry Criteria

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/mm³ 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

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

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

Expected Enrollment

A total of 450 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

P. Ljungman, MD, Protocol chair		Ph: 46-8-585-800-00 Email: Per.Ljungman@ki.se

Registry Information
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
Trial Start Date		1999-06-02
Registered in ClinicalTrials.gov		NCT00003938
Date Submitted to PDQ		1999-06-17
Information Last Verified		2000-03-01

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