Clinical trial NCT00238355: Voriconazole and Caspofungin Acetate in Treating Invasive Fungal Infections in Patients With Weakened Immune Systems
Official title: Phase II Trial of Voriconazole Plus Caspofungin for the Initial Treatment of Invasive Fungal Infections
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Infection
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: infection
unspecified adult solid tumor, protocol specific
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-10-13
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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 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)

Primary outcomes:
measure: Number of Participants With a Complete or Partial Response Rate to the Combination of Voriconazole and Caspofungin at 12 Weeks.
timeFrame: 12 weeks after starting treatment
Secondary outcomes:
measure: Survival at 12 Weeks
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Lynne Strasfeld, MD
role: STUDY_CHAIR
References: