Clinical trial · Interventional
Voriconazole and Caspofungin Acetate in Treating Invasive Fungal Infections in Patients With Weakened Immune Systems
Phase II Trial of Voriconazole Plus Caspofungin for the Initial Treatment of Invasive Fungal Infections
NCT00238355CI-TRIAL-00088973terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): competing study at site
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infection | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| caspofungin acetate | Drug | — | UNRESOLVED |
| voriconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Voriconazole plus Caspofungin
- interventionNames
- Drug: caspofungin acetate
- Drug: voriconazole
Primary outcomes (1)
- 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
- 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.
Secondary outcomes (1)
- measure
- Survival at 12 Weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.