Status:
COMPLETED
Caspofungin Acetate in Treating Aspergillosis in Patients With Hematologic Cancer or in Patients Who Have Undergone a Stem Cell Transplant
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Antifungals, such as caspofungin acetate, may be effective in treating fungal infections caused by chemotherapy or stem cell transplant. PURPOSE: This phase II trial is studying how well c...
Detailed Description
OBJECTIVES: Primary * Determine the activity of caspofungin acetate as first-line therapy for proven or probable invasive aspergillosis, in terms of response rate, in patients with hematologic malig...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of proven or probable invasive aspergillosis (IA)
- Patients with a diagnosis of possible IA are eligible provided they are upgraded to probable or proven IA by culture and/or histology results and Aspergillus galactomannan evaluation within 7 days after study entry
- Meets any of the following criteria:
- Diagnosis of a hematologic malignancy
- Underwent autologous or allogeneic hematopoietic stem cell transplantation
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Karnofsky 20-100%
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- AST and ALT ≤ 5 times upper limit of normal (ULN)
- Bilirubin ≤ 5 times ULN
- Alkaline phosphatase ≤ 5 times ULN
- No severe hepatic insufficiency
- Child-Pugh score ≤ 9
- Renal
- No severe renal failure requiring hemodialysis or peritoneal dialysis
- Creatinine \< 3.4 mg/dL
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method contraception
- No known HIV positivity
- No history of allergy or adverse reaction to echinocandin drugs
- No known bacterial infection that is not adequately treated
- No psychological, familial, social, or geographical condition that would preclude study participation or compliance
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics
- Chemotherapy
- Not specified
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- Prior empirical antifungal therapy allowed provided treatment duration was ≤ 72 hours
- Prior prophylactic oral antifungals allowed
- Prior prophylactic IV fluconazole allowed
- More than 14 days since prior and no concurrent investigational agents
- No prior participation in this study
- No prior echinocandins
- No other concurrent antifungal therapy
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT00110045
Start Date
February 1 2005
Last Update
September 24 2012
Active Locations (13)
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1
CHU Liege - Domaine Universitaire du Sart Tilman
Liège, Belgium, B-4000
2
Centre Hospitalier Universitaire Henri Mondor
Créteil, France, 94010
3
Hopital Edouard Herriot - Lyon
Lyon, France, 69437
4
Hopital Saint-Louis
Paris, France, 75475