InfectionPhase 2NCT00238355
Voriconazole and Caspofungin Acetate in Treating Invasive Fungal Infections in Patients With Weakened Immune Systems
A Phase 2 study testing caspofungin acetate and voriconazole in people with Infection and Unspecified Adult Solid Tumor, Protocol Specific, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Infection, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- caspofungin acetate and voriconazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Jun 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239-3098
About this study
Official title: Phase II Trial of Voriconazole Plus Caspofungin for the Initial Treatment of Invasive Fungal Infections
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.
Read the 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.
- Being tested
- caspofungin acetate, voriconazole
- Keywords
- infection, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caspofungin acetateDrug
70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84.
voriconazoleDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Voriconazole plus Caspofungin | Experimental | Not described Receives: Drug: caspofungin acetate; Drug: voriconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after starting treatment
Secondary outcomes (1)
Survival at 12 Weeks
Defined as the number of evaluable subjects alive at 12 weeks (84 days) following registration.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2005 (estimated)
- Study startAug 2003
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: competing study at site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lynne Strasfeld, MD, Study chair, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238355
- Sponsor's protocol ID
- CDR0000445848
- Other IDs
- OHSU-HEM-0346-L, OHSU-IRB-1379
- Status last verified
- Apr 2025
- First submitted
- 12 Oct 2005
- Last updated
- 27 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Voriconazole Plus Caspofungin for the Initial Treatment of Invasive Fungal Infections
- ClinicalTrials.gov ID
- NCT00238355
- Acronym / sponsor ID
- CDR0000445848
- Keywords
- infection, unspecified adult solid tumor, protocol specific
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: competing study at site
- Enrolment
- 13 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2003
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 13 Oct 2005 (estimated)
- Results
- Posted 9 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Voriconazole plus Caspofungin | Experimental | Drug: caspofungin acetate, Drug: voriconazole |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| caspofungin acetate70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84. | Drug | Voriconazole plus Caspofungin |
| voriconazole6mg/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). | Drug | Voriconazole plus Caspofungin |
Primary outcome
Number of Participants With a Complete or Partial Response Rate to the Combination of Voriconazole and Caspofungin at 12 Weeks.
Time frame: 12 weeks after starting treatment
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.
1 secondary outcome
Survival at 12 Weeks
Time frame: up to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynne Strasfeld, MD study chair
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing caspofungin acetate and voriconazole in people with Infection and Unspecified Adult Solid Tumor, Protocol Specific, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Complete or Partial Response Rate to the Combination of Voriconazole and Caspofungin at 12 Weeks. (time frame: 12 weeks after starting treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.