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

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

Locations7 sites

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