A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer
NCT05563766
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.
Eligibility
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
Conditions4
Interventions1
Locations7 sites
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NCT05563766