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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00003938
First received: November 1, 1999
Last updated: September 20, 2012
Last verified: September 2012

November 1, 1999
September 20, 2012
June 1999
May 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003938 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Supportive Care
Cancer
Drug: liposomal amphotericin B
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
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May 2003   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Greece,   France,   Israel,   Spain,   Portugal,   Sweden,   Italy,   Slovakia,   Turkey,   Hungary,   United Arab Emirates,   Germany,   Czech Republic,   Netherlands
 
NCT00003938
EORTC-19951, EORTC-19951
Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
Not Provided
Study Chair: P. Ljungman, MD Karolinska Institutet
European Organisation for Research and Treatment of Cancer - EORTC
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP