Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00238355
Recruitment Status : Terminated (competing study at site)
First Posted : October 13, 2005
Results First Posted : December 9, 2011
Last Update Posted : December 19, 2011
National Cancer Institute (NCI)
Information provided by (Responsible Party):
OHSU Knight Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Infection Unspecified Adult Solid Tumor, Protocol Specific Drug: caspofungin acetate Drug: voriconazole Phase 2

Detailed Description:



  • Determine the 12-week complete and partial response rate in immunocompromised patients with invasive fungal infections treated with voriconazole and caspofungin acetate.


  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Phase II Trial of Voriconazole Plus Caspofungin for the Initial Treatment of Invasive Fungal Infections
Study Start Date : August 2003
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Voriconazole plus Caspofungin 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).

Primary Outcome Measures :
  1. 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 ]
    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.

Secondary Outcome Measures :
  1. Duration of Survival up to 12 Weeks [ Time Frame: up to 12 weeks ]
  2. Safety [ Time Frame: duration of study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Not specified

Life expectancy

  • At least 72 hours


  • Not specified


  • AST < 5 times upper limit of normal (ULN)
  • Bilirubin < 5 times ULN
  • Alkaline phosphatase < 5 times ULN
  • No Child-Pugh class C cirrhosis


  • Creatinine clearance ≥ 50 mL/min


  • No mechanical ventilation


  • 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


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00238355

Layout table for location information
United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Lynne Strasfeld, MD OHSU Knight Cancer Institute

Layout table for additonal information
Responsible Party: OHSU Knight Cancer Institute Identifier: NCT00238355    
Other Study ID Numbers: CDR0000445848
OHSU-HEM-0346-L ( Other Identifier: OHSU Knight Cancer Institute )
OHSU-IRB-1379 ( Other Identifier: OHSU IRB )
First Posted: October 13, 2005    Key Record Dates
Results First Posted: December 9, 2011
Last Update Posted: December 19, 2011
Last Verified: December 2011
Keywords provided by OHSU Knight Cancer Institute:
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Invasive Fungal Infections
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors