Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care Active 18 and over NCI OHSU-HEM-0346-L OHSU-IRB-1379, NCT00238355

Objectives

Primary

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

Secondary

1. Determine the 12-week survival rate in patients treated with this regimen.
2. Determine the safety of this regimen in these patients.

Entry 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

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)

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

Expected Enrollment

A total of 47 patients will be accrued for this study.

Outcomes

12-week complete and partial response rate

Duration of survival up to 12 weeks
Safety

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.

Trial Contact Information

Trial Lead Organizations

Oregon Health and Science University Cancer Institute

Lynne Strasfeld, MD, Protocol chair		Ph: 503-494-7735; 800-494-1234

U.S.A.
Oregon
	Portland
	Oregon Health and Science University Cancer Institute
		Clinical Trials Office - Oregon Health and Science University Cancer Institute	Ph:  503-494-1080
			Email: trials@ohsu.edu

Registry Information
Official Title		Phase II Trial of Voriconazole Plus Caspofungin for the Initial Treatment of Invasive Fungal Infections
Trial Start Date		2003-08-28
Registered in ClinicalTrials.gov		NCT00238355
Date Submitted to PDQ		2005-08-22
Information Last Verified		2008-08-08
NCI Grant/Contract Number		CA69533