Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment
Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer
Intervention: caspofungin acetate (Drug); liposomal amphotericin B (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Memorial Sloan Kettering Cancer Center Official(s) and/or principal investigator(s):
Kent Sepkowitz, MD, Study Chair, Affiliation: Memorial Sloan Kettering Cancer Center
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.
Clinical Details
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 design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
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.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: August 2000
Last updated: January 17, 2013
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