Infection, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
infection, unspecified adult solid tumor, protocol specific
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.
Interventions
70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84.
DRUGvoriconazole
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).
Sponsors
National Cancer Institute (NCI)
OHSU Knight Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Complete or Partial Response Rate to the Combination of Voriconazole and Caspofungin at 12 Weeks. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival at 12 Weeks | up to 12 weeks | Defined as the number of evaluable subjects alive at 12 weeks (84 days) following registration. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Voriconazole Plus Caspofungin Voriconazole: 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
Caspofungin: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Voriconazole Plus Caspofungin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 45.916 years STANDARD_DEVIATION 15.37 |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 10 / 13 |
Outcome results
Primary
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.
Time frame: 12 weeks after starting treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Voriconazole Plus Caspofungin | Number of Participants With a Complete or Partial Response Rate to the Combination of Voriconazole and Caspofungin at 12 Weeks. | 4 Participants |
Secondary
Survival at 12 Weeks
Defined as the number of evaluable subjects alive at 12 weeks (84 days) following registration.
Time frame: up to 12 weeks
Population: 3 subjects were not evaluable for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Voriconazole Plus Caspofungin | Survival at 12 Weeks | 4 participants |