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Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment

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ClinicalTrials.gov Identifier: NCT00008359
Recruitment Status : Completed
First Posted : September 4, 2003
Last Update Posted : January 18, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:

RATIONALE: Caspofungin acetate or amphotericin B liposomal may be effective in preventing or controlling fever and neutropenia caused by chemotherapy, bone marrow transplantation, or peripheral stem cell transplantation. It is not yet known whether caspofungin acetate or amphotericin B liposomal is more effective for treating these side effects.

PURPOSE: Randomized phase III trial to compare the effectiveness of caspofungin acetate with that of amphotericin B liposomal in treating patients who have persistent fever and neutropenia after receiving anticancer therapy.


Condition or disease Intervention/treatment Phase
Cancer Drug: caspofungin acetate Drug: liposomal amphotericin B Phase 3

Detailed Description:

OBJECTIVES:

  • Compare the number of successful treatment outcomes among patients treated with caspofungin acetate vs amphotericin B liposomal for persistent fever and neutropenia following cancer therapy, in terms of survival for 7 days after study drug, resolution of fever, treatment of any baseline fungal infection, absence of breakthrough fungal infection during and for 7 days after study drug, and absence of study drug discontinuation due to toxicity or lack of efficacy.
  • Compare the incidence of nephrotoxicity in patients treated with these regimens.
  • Compare the incidence of infusion-related adverse events within 1 hour of the infusion in patients treated with these regimens.
  • Compare the incidence of treatment discontinuation due to drug-related adverse events, frequency of drug-related events, number of breakthrough fungal infections, and number of successfully treated baseline fungal infections in patients treated with these regimens.
  • Compare incidence of required dose increase due to inadequate clinical response in patients treated with these regimens.
  • Compare the time to resolution of fever in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to high-risk (prior allogeneic bone marrow transplantation or prior chemotherapy for relapse of acute leukemia) vs low-risk and prior prophylactic antifungal therapy during chemotherapy (yes vs no). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive caspofungin acetate IV over 1 hour followed by placebo IV over 2 hours.
  • Arm II: Patients receive placebo IV over 1 hour followed by amphotericin B liposomal IV over 2 hours.

Treatment repeats daily for up to 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 7 and 14 days after study drug discontinuation.

PROJECTED ACCRUAL: A total of 1060 patients (530 per arm) will be accrued for this study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
Official Title: A Multicenter, Double-Blind, Randomized, Comparative Study To Evaluate The Safety, Tolerability, And Efficacy Of MK-0991 Versus (Amphotericin B) Liposome For Injection As Empirical Therapy In Patients With Persistent Fever And Neutropenia
Study Start Date : August 2000
Actual Primary Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
Genetic and Rare Diseases Information Center resources: Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Multiple Myeloma Lymphosarcoma Hodgkin Lymphoma Primary Myelofibrosis Myelodysplastic Syndromes Ovarian Cancer Chronic Lymphocytic Leukemia Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma B-cell Lymphoma Ovarian Epithelial Cancer Neuroblastoma Chronic Myeloid Leukemia Peripheral T-cell Lymphoma Marginal Zone Lymphoma Primary Central Nervous System Lymphoma Mantle Cell Lymphoma Diffuse Large B-Cell Lymphoma Burkitt Lymphoma AL Amyloidosis Chronic Graft Versus Host Disease Granulocytopenia Monoclonal Gammopathy of Undetermined Significance Follicular Lymphoma Mycosis Fungoides Cutaneous T-cell Lymphoma Acute Graft Versus Host Disease Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Waldenstrom Macroglobulinemia Hairy Cell Leukemia Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Gestational Trophoblastic Tumor Aggressive NK Cell Leukemia T-cell Large Granular Lymphocyte Leukemia Polycythemia Vera Embryonal Carcinoma Choriocarcinoma Anaplastic Large Cell Lymphoma Testicular Seminoma Adult T-cell Leukemia/lymphoma Ovarian Germ Cell Tumor Essential Thrombocythemia Sezary Syndrome Wilms' Tumor Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Plasmacytoma Leukemia, T-cell, Chronic Testicular Yolk Sac Tumor Polyembryoma

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Leukemia, lymphoma, or other cancer that has been previously treated with chemotherapy or bone marrow or peripheral blood stem cell transplantation
  • Absolute neutrophil count less than 500/mm^3 for past 96 hours and not expected to recover in next 48 hours
  • Received at least 96 hours of parenteral systemic antibacterial therapy
  • Fever greater than 38.0 degrees Celsius

  • Adequately managed bacterial infection allowed if all of the following are true:

    • Negative blood cultures
    • Received at least 5 days of antibiotics to which any bacterial isolates are sensitive
    • Surgical drainage of any abscess fluid or surgical debridement of infected tissues
    • Removal of infected catheters
  • No invasive fungal infection
  • Not previously enrolled on this study

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Performance status:

  • Karnofsky 30-100%

Life expectancy:

  • At least 5 days

Hematopoietic:

  • Platelet count at least 5,000/mm^3
  • INR no greater than 1.6 (no greater than 4.0 if receiving anticoagulants)

Hepatic:

  • Bilirubin no greater than 3 times upper limit of normal (ULN)
  • AST or ALT no greater than 5 times ULN
  • Alkaline phosphatase no greater than 3 times ULN
  • No acute hepatitis or cirrhosis

Renal:

  • Not specified

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • No allergy, hypersensitivity, or prior serious reaction to any echinocandin antifungal or amphotericin B formulation
  • No other condition or illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • See Disease Characteristics
  • No concurrent investigational antineoplastic therapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • At least 10 days since prior parenteral amphotericin B
  • At least 14 days since prior investigational antibiotic, antifungal, or immunosuppressive drug
  • No concurrent rifampin or cyclosporine
  • No other concurrent investigational antibiotic, antifungal, or immunosuppressive drug
  • No concurrent alcohol
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00008359


Locations
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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
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Study Chair: Kent Sepkowitz, MD Memorial Sloan Kettering Cancer Center
More Information
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Publications of Results:

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ClinicalTrials.gov Identifier: NCT00008359    
Other Study ID Numbers: 00-085
MSKCC-00085
MERCK-026-01
NCI-G00-1898
First Posted: September 4, 2003    Key Record Dates
Last Update Posted: January 18, 2013
Last Verified: January 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
stage IV breast cancer
stage IIIA breast cancer
monoclonal gammopathy of undetermined significance
stage IIIB breast cancer
recurrent adult Hodgkin lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
isolated plasmacytoma of bone
 extramedullary plasmacytoma
refractory multiple myeloma
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
disseminated neuroblastoma
recurrent neuroblastoma
recurrent Wilms tumor and other childhood kidney tumors
stage 0 chronic lymphocytic leukemia
Waldenstrom macroglobulinemia
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
stage I chronic lymphocytic leukemia
Additional relevant MeSH terms:
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Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Amphotericin B
Liposomal amphotericin B
Caspofungin
 Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action