Trial Outcomes & Findings for Voriconazole and Caspofungin Acetate in Treating Invasive Fungal Infections in Patients With Weakened Immune Systems (NCT NCT00238355)

Last Updated: 2025-04-27

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

12 weeks after starting treatment

Results posted on

2025-04-27

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	13
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Voriconazole Plus Caspofungin n=13 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	45.916 years STANDARD_DEVIATION 15.370 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after starting treatment

Outcome measures

Outcome measures
Measure	Voriconazole Plus Caspofungin n=13 Participants 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.
Number of Participants With a Complete or Partial Response Rate to the Combination of Voriconazole and Caspofungin at 12 Weeks.	4 Participants

SECONDARY outcome

Timeframe: up to 12 weeks

Population: 3 subjects were not evaluable for this outcome.

Defined as the number of evaluable subjects alive at 12 weeks (84 days) following registration.

Outcome measures

Outcome measures
Measure	Voriconazole Plus Caspofungin n=10 Participants 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.
Survival at 12 Weeks	4 participants

Adverse Events

Voriconazole Plus Caspofungin

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Voriconazole Plus Caspofungin n=13 participants at risk 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.
Blood and lymphatic system disorders Sepsis	7.7% 1/13
Renal and urinary disorders Liver and Renal failure	7.7% 1/13
Gastrointestinal disorders Diarrhea	7.7% 1/13
General disorders Abdominal Pain	15.4% 2/13
Psychiatric disorders Altered Mental State	7.7% 1/13
Vascular disorders Cerebral Hemorrhage	7.7% 1/13
Respiratory, thoracic and mediastinal disorders Respiratory Distress	7.7% 1/13
Gastrointestinal disorders Colitis	7.7% 1/13
Respiratory, thoracic and mediastinal disorders Dyspnea	7.7% 1/13
General disorders Disease Progression	15.4% 2/13
Vascular disorders Intracerebral Hemorrhage	7.7% 1/13
Respiratory, thoracic and mediastinal disorders Pulmonary Infection	7.7% 1/13

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lynne Strasfeld

OHSU Knight Cancer Institute

Phone: 503-494-1551

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place