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

NCT ID: NCT00238355

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2008-06-30

Brief 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.

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.

Conditions

Infection; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Voriconazole plus Caspofungin

Group Type: EXPERIMENTAL

caspofungin acetate

Intervention Type: DRUG

70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84.

voriconazole

Intervention Type: DRUG

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).

Interventions

caspofungin acetate

70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84.

Intervention Type: 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).

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynne Strasfeld, MD

Role: STUDY_CHAIR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

Other Identifiers

OHSU-HEM-0346-L

Identifier Type: OTHER

Identifier Source: secondary_id

OHSU-IRB-1379

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000445848

Identifier Type: -

Identifier Source: org_study_id