Voriconazole and Caspofungin Acetate in Treating Invasive Fungal Infections in Patients With Weakened Immune Systems

Official Title: “Phase II Trial of Voriconazole Plus Caspofungin for the Initial Treatment of Invasive Fungal Infections”

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.

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.

Intervention(s) in this Clinical Trial

• Drug: caspofungin acetate
  • 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84.
• Drug: voriconazole
  • 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses. Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours (at least one hour before or after meals).

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Voriconazole plus Caspofungin

Primary Measures

• Number of Participants With a Complete or Partial Response Rate to the Combination of Voriconazole and Caspofungin at 12 Weeks.
  • Time Frame: 12 weeks after starting treatment
    Safety Issue?: Yes

Secondary Measures

• Duration of Survival up to 12 Weeks
  • Time Frame: up to 12 weeks
    Safety Issue?: No
• Safety
  • Time Frame: duration of study
    Safety Issue?: Yes

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: OHSU Knight Cancer Institute Other

Overall Clinical Trial Officials and Contacts

Lynne Strasfeld, MD Study Chair OHSU Knight Cancer Institute  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00238355

Study ID Number: CDR0000445848

ClinicalTrials.gov Identifier: NCT00238355

Health Authority: United States: Food and Drug Administration