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

This study has been terminated.
(competing study at site)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00238355
First received: October 12, 2005
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Infection
Unspecified Adult Solid Tumor, Protocol Specific
Drug: caspofungin acetate
Drug: voriconazole
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Phase II Trial of Voriconazole Plus Caspofungin for the Initial Treatment of Invasive Fungal Infections

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • Duration of Survival up to 12 Weeks [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: August 2003
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238355

Locations
United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Study Chair: Lynne Strasfeld, MD OHSU Knight Cancer Institute
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00238355     History of Changes
Other Study ID Numbers: CDR0000445848, OHSU-HEM-0346-L, OHSU-IRB-1379
Study First Received: October 12, 2005
Results First Received: November 7, 2011
Last Updated: December 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by OHSU Knight Cancer Institute:
infection
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Communicable Diseases
Infection
Mycoses
Caspofungin
Echinocandins
Voriconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014