ClinicalTrials.Veeva

Menu

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

OHSU Knight Cancer Institute logo

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)

13 participants in 1 patient group

Voriconazole plus Caspofungin
Experimental group
Treatment:
Drug: voriconazole
Drug: caspofungin acetate

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems