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

NCT00238355 | Terminated Phase 2 Results DMC

• 3 other identifiers: CDR0000445848OHSU-HEM-0346-LOHSU-IRB-1379
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

infection; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks after starting treatment

Secondary Outcomes (1)

• Survival at 12 Weeks

  up to 12 weeks

Study Arms (1)

Voriconazole plus Caspofungin

EXPERIMENTAL

Drug: caspofungin acetate; Drug: voriconazole

Interventions

caspofungin acetate DRUG

70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84.

Voriconazole plus Caspofungin

voriconazole DRUG

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).

Voriconazole plus Caspofungin

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

Infections

Interventions

Caspofungin; Voriconazole

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Lynne Strasfeld
• Organization: OHSU Knight Cancer Institute

strasfel@ohsu.edu

503-494-1551

Study Officials

• Lynne Strasfeld, MD

  OHSU Knight Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2005
• First Posted: October 13, 2005
• Study Start: August 1, 2003
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: April 27, 2025
• Results First Posted: December 9, 2011

Record last verified: 2025-04

Locations

US (1)