A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer
VA Office of Research and Development
78 participants
Oct 1, 2024
INTERVENTIONAL
Conditions
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 Criteria4
- 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 Criteria6
- 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
Interventions
Itraconazole 300 mg po bid for two weeks prior and 6-8 weeks after completion of standard of care neoadjuvant chemoradiation
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05563766