About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Inability to provide Informed Consent
NYHA class III or IV CHF
LFT>3X upper limit of normal
Drug allergy to itraconazole
Trial design
Treatments tested in this trial
- Itraconazole
Treatment groups
Sponsors and collaborators
VA Office of Research and Development
Lead sponsor
Durham VA Health Care System
Collaborator
VA Palo Alto Health Care System
Collaborator
Portland VA Medical Center
Collaborator
VA Puget Sound Health Care System
Collaborator
Michael E. DeBakey VA Medical Center
Collaborator
VA Boston Healthcare System
Collaborator
North Texas Veterans Healthcare System
Collaborator
VA Ann Arbor Healthcare System
Collaborator