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

OHSU Knight Cancer Institute

Status and phase: Terminated; Phase 2

Conditions: Infection; Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Drug: voriconazole; Drug: caspofungin acetate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00238355

OHSU-IRB-1379 (Other Identifier)

CDR0000445848

OHSU-HEM-0346-L (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Voriconazole plus Caspofungin

Experimental group

Treatment:

Drug: voriconazole

Drug: caspofungin acetate