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| Descriptive Information Fields | |||||
| 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 | ||||
| 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. |
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| Detailed Description | OBJECTIVES:
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.
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. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Supportive Care, Randomized, Double-Blind, Placebo Control | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Cancer | ||||
| Intervention † | Drug: caspofungin acetate Drug: liposomal amphotericin B |
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| MEDLINE PMIDs | 15459300 | ||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | |||||
| Start Date † | August 2000 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00008359 | ||||
| Organization ID | CDR0000068400 | ||||
| Secondary IDs †† | MSKCC-00085, MERCK-026-01, NCI-G00-1898 | ||||
| Study Sponsor † | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | July 2007 | ||||
| First Received Date † | January 6, 2001 | ||||
| Last Updated Date | July 23, 2008 | ||||