Evaluating the Effect of Itraconazole on Pathologic Complete Response Rates in Esophageal Cancer

• Status: Recruiting
• Trial end date: 2026-09-29
• Target enrollment: 0
• Participant gender: All

Summary

Esophageal cancer, which has a low 5-year overall survival rate for all stages (<20%) , is increasing in incidence. Previous studies have shown that the Hedgehog (Hh) and AKT signaling pathways are activated in a significant proportion of esophageal cancers. Itraconazole, a widely used anti-fungal medication, has been shown to inhibit various pathways involved in esophageal cancer tumorigenesis including Hh and AKT. In this phase II clinical trial, the investigators aim to evaluate the effect of itraconazole as a neoadjuvant therapy following standard of care chemoradiation in the treatment of locoregional esophageal and gastroesophageal junction carcinomas.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dallas VA Medical Center
• Treatments: Hydroxyitraconazole; Itraconazole

Criteria

Inclusion Criteria:

• Patients diagnosed with localized (locoregional) esophageal cancer

• Patients diagnosed with localized (locoregional) gastroesophageal junction cancer

Exclusion Criteria:

• Patients unwilling or unable to provide informed consent

• Patients with QTc>450ms

• Patients with a history of symptomatic congestive heart failure

• Patients with LFT's>3xULN

• Patients who are pregnant

• Patients with a known allergy to itraconazole