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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

Phase II Trial of Voriconazole Plus Caspofungin for the Initial Treatment of Invasive Fungal Infections

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00238355
• Other study ID #: CDR0000445848
• Secondary ID: OHSU-HEM-0346-LO
• Status: Terminated
• Phase: Phase 2
• First received: October 12, 2005
• Last updated: December 12, 2011
• Start date: August 2003
• Est. completion date: June 2008

Study information

• Verified date: December 2011
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Mycoses
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a Complete or Partial Response Rate to the Combination of Voriconazole and Caspofungin at 12 Weeks.	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.	12 weeks after starting treatment	Yes
Secondary	Duration of Survival up to 12 Weeks		up to 12 weeks	No
Secondary	Safety		duration of study	Yes