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

Primary Purpose

Infection, Unspecified Adult Solid Tumor, Protocol Specific

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
caspofungin acetate
voriconazole
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infection focused on measuring infection, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Voriconazole plus Caspofungin

Arm Description

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
October 12, 2005
Last Updated
December 12, 2011
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00238355
Brief Title
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

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Terminated
Why Stopped
competing study at site
Study Start Date
August 2003 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
infection, unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Voriconazole plus Caspofungin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
caspofungin acetate
Intervention Description
70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84.
Intervention Type
Drug
Intervention Name(s)
voriconazole
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of Participants With a Complete or Partial Response Rate to the Combination of Voriconazole and Caspofungin at 12 Weeks.
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.
Time Frame
12 weeks after starting treatment
Secondary Outcome Measure Information:
Title
Duration of Survival up to 12 Weeks
Time Frame
up to 12 weeks
Title
Safety
Time Frame
duration of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynne Strasfeld, MD
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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