Caspofungin Acetate Compared With Amphotericin B Liposoma... | NCT00008359 | Trialant
NCT00008359
Sponsor
Memorial Sloan Kettering Cancer Center
Status
Completed
Last Update Posted
Jan 18, 2013Estimated
Enrollment
Not provided
Phase
Phase 3
Conditions
Cancer
Interventions
caspofungin acetate
liposomal amphotericin B
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00008359
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
00-085
Secondary IDs
ID
Type
Description
Link
MSKCC-00085
MERCK-026-01
NCI-G00-1898
Brief Title
Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment
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
Acronym
Not provided
Organization
Memorial Sloan Kettering Cancer CenterOTHER
Status Module
Record Verification Date
Jan 2013
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2000
Primary Completion Date
Mar 2003Actual
Completion Date
Not provided
First Submitted Date
Jan 6, 2001
First Submission Date that Met QC Criteria
Sep 3, 2003
First Posted Date
Sep 4, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 17, 2013
Last Update Posted Date
Jan 18, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Memorial Sloan Kettering Cancer CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
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.
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.
Conditions Module
Conditions
Cancer
Keywords
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
Not provided
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
caspofungin acetate
Drug
liposomal amphotericin B
Drug
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility 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
Walsh TJ, Teppler H, Donowitz GR, Maertens JA, Baden LR, Dmoszynska A, Cornely OA, Bourque MR, Lupinacci RJ, Sable CA, dePauw BE. Caspofungin versus liposomal amphotericin B for empirical antifungal therapy in patients with persistent fever and neutropenia. N Engl J Med. 2004 Sep 30;351(14):1391-402. doi: 10.1056/NEJMoa040446.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
small intestine lymphoma
stage III malignant testicular germ cell tumor
recurrent malignant testicular germ cell tumor
unspecified adult solid tumor, protocol specific
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
polycythemia vera
primary myelofibrosis
essential thrombocythemia
fever, sweats, and hot flashes
testicular embryonal carcinoma
testicular choriocarcinoma
testicular teratoma
testicular yolk sac tumor
testicular embryonal carcinoma and teratoma
testicular embryonal carcinoma and teratoma with seminoma
testicular embryonal carcinoma and yolk sac tumor
testicular embryonal carcinoma and yolk sac tumor with seminoma
testicular embryonal carcinoma and seminoma
testicular yolk sac tumor and teratoma
testicular yolk sac tumor and teratoma with seminoma
testicular choriocarcinoma and yolk sac tumor
testicular choriocarcinoma and embryonal carcinoma