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

Information source: OHSU Knight Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infection; Unspecified Adult Solid Tumor, Protocol Specific

Intervention: caspofungin acetate (Drug); voriconazole (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: OHSU Knight Cancer Institute

Official(s) and/or principal investigator(s):
Lynne Strasfeld, MD, Study Chair, Affiliation: OHSU Knight Cancer Institute

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.

Clinical Details

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

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

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

Secondary outcome:

Duration of Survival up to 12 Weeks

Safety

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

OHSU Knight Cancer Institute, Portland, Oregon 97239-3098, United States
Additional Information

Starting date: August 2003
Last updated: December 12, 2011

Page last updated: August 23, 2015

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