A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer

• Status: Not yet recruiting
• Trial end date: 2028-12-15
• Target enrollment: 0
• Participant gender: All

Summary

Esophageal cancer, which has a low 5-year overall survival rate (<20%) is increasing in incidence. Previous studies have shown that Hedgehog, AKT, and angiogenic signaling pathways are activated in a significant number of esophageal cancers. Itraconazole, a widely used anti-fungal medication, effectively inhibits these pathways. In this multi-site phase II trial, the investigators will evaluate the effect of itraconazole as a neoadjuvant therapy added to standard of care chemoradiation and surgery in the the treatment of locoregional esophageal and gastroesophageal junction cancers.

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

Details

• Lead Sponsor: VA Office of Research and Development
• Collaborators: Durham VA Health Care System; Michael E. DeBakey VA Medical Center; Portland VA Medical Center; VA Boston Healthcare System; VA Palo Alto Health Care System; VA Puget Sound Health Care System
• Treatments: Itraconazole

Criteria

Inclusion Criteria:

• Capable of giving informed consent

• Pathologic diagnosis of esophageal cancer (ESCC or EAC) or GEJ cancer deemed resectable by a surgeon with a plan to undergo neoadjuvant chemoradiation and curative intent esophagectomy

• World Health Organization (WHO)/ECOG performance status (PS) of 0-2 at enrollment

• Adequate renal and liver function as judged by the treating physician

Exclusion Criteria:

• Inability to provide Informed Consent

• NYHA class III or IV CHF

• LFT>3X upper limit of normal

• Drug allergy to itraconazole

• Positive pregnancy test

• Those with QTc>450 ms will have QTc monitored during therapy by serial EKG to ensure QTc does not lengthen to what the treating clinician considers significant