Phase II Trial of Voriconazole Plus Caspofungin for the Initial Treatment of Invasive Fungal Infections
18 Years
N/A
Both
Infection, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase II Trial of Voriconazole Plus Caspofungin for the Initial Treatment of Invasive Fungal Infections
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.
Inclusion 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)
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Number of Participants With a Complete or Partial Response Rate to the Combination of Voriconazole and Caspofungin at 12 Weeks.
Outcome Description:
Patients will be followed through day 84 (12 weeks), regardless of continuation of study drugs. Complete response: Resolution of all clinical signs and symptoms and more than 90 percent of the lesions due to invasive fungus that were visible by radiology. Partial response: Clinical improvement and greater than 50 percent improvement in the lesions due to invasive fungus that were visible by radiology.
Outcome Time Frame:
12 weeks after starting treatment
Safety Issue:
Yes
Principal Investigator
Lynne Strasfeld, MD
Investigator Role:
Study Chair
Investigator Affiliation:
OHSU Knight Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000445848
NCT ID:
NCT00238355
Start Date:
August 2003
Completion Date:
June 2008
Related Keywords:
- Infection
- Unspecified Adult Solid Tumor, Protocol Specific
- infection
- unspecified adult solid tumor, protocol specific
- Mycoses
Name | Location |
|---|---|
| OHSU Knight Cancer Institute | Portland, Oregon 97239 |
