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Phase II Trial of Voriconazole Plus Caspofungin for the Initial Treatment of Invasive Fungal Infections


Phase 2
18 Years
N/A
Not Enrolling
Both
Infection, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase II Trial of Voriconazole Plus Caspofungin for the Initial Treatment of Invasive Fungal Infections


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.

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)

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Number of Participants With a Complete or Partial Response Rate to the Combination of Voriconazole and Caspofungin at 12 Weeks.

Outcome Description:

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.

Outcome Time Frame:

12 weeks after starting treatment

Safety Issue:

Yes

Principal Investigator

Lynne Strasfeld, MD

Investigator Role:

Study Chair

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000445848

NCT ID:

NCT00238355

Start Date:

August 2003

Completion Date:

June 2008

Related Keywords:

  • Infection
  • Unspecified Adult Solid Tumor, Protocol Specific
  • infection
  • unspecified adult solid tumor, protocol specific
  • Mycoses

Name

Location

OHSU Knight Cancer InstitutePortland, Oregon  97239