Voriconazole and Caspofungin Acetate in Treating Invasive Fungal Infections in Patients With Weakened Immune Systems
Information source: OHSU Knight Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: caspofungin acetate (Drug); voriconazole (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: OHSU Knight Cancer Institute Official(s) and/or principal investigator(s):
Lynne Strasfeld, MD, Study Chair, Affiliation: OHSU Knight Cancer Institute
Summary
RATIONALE: Voriconazole and caspofungin acetate may control invasive fungal infections in
patients who have weakened immune systems.
PURPOSE: This phase II trial is studying how well giving voriconazole together with
caspofungin acetate works in treating invasive fungal infections in patients with weakened
immune systems.
Clinical Details
Official title: Phase II Trial of Voriconazole Plus Caspofungin for the Initial Treatment of Invasive Fungal Infections
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Number of Participants With a Complete or Partial Response Rate to the Combination of Voriconazole and Caspofungin at 12 Weeks.
Secondary outcome: Duration of Survival up to 12 WeeksSafety
Detailed description:
OBJECTIVES:
Primary
- Determine the 12-week complete and partial response rate in immunocompromised patients
with invasive fungal infections treated with voriconazole and caspofungin acetate.
Secondary
- Determine the 12-week survival rate in patients treated with this regimen.
- Determine the safety of this regimen in these patients.
OUTLINE: Patients receive voriconazole orally or IV over 1 hour twice daily and caspofungin
acetate IV over 1 hour once daily on days 1-84. Treatment continues in the absence of
disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- Diagnosis of probable or definite invasive fungal infection with 1 of the following
organisms:
- Aspergillus species
- Fusarium species
- Scedosporium species (Pseudallescheria boydii)
- Other dematiaceous molds
- The following diagnosis are not allowed:
- Zygomycetes (Mucor or Rhizopus species)
- Chronic aspergillosis
- Aspergilloma
- Allergic bronchopulmonary aspergillosis
- Must be immunocompromised
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- At least 72 hours
Hematopoietic
- Not specified
Hepatic
- AST < 5 times upper limit of normal (ULN)
- Bilirubin < 5 times ULN
- Alkaline phosphatase < 5 times ULN
- No Child-Pugh class C cirrhosis
Renal
- Creatinine clearance ≥ 50 mL/min
Pulmonary
- No mechanical ventilation
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No hypersensitivity to azoles, caspofungin acetate, or their components
- No history of galactose intolerance, Lapp lactase deficiency, or glucose-galactose
malabsorption
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 14 days since prior therapeutic antifungal therapy of ≥ 1 week duration
- More than 14 days since prior and no concurrent administration of any of the
following medications:
- Terfenadine
- Astemizole
- Cisapride
- Pimozide
- Quinidine
- Sirolimus
- Rifampin
- Carbamazepine
- Long-acting barbiturates
- Rifabutin
- Ergot alkaloids (i. e., ergotamine and dihydroergotamine)
Locations and Contacts
OHSU Knight Cancer Institute, Portland, Oregon 97239-3098, United States
Additional Information
Starting date: August 2003
Last updated: December 12, 2011
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