Evaluating the Effect of Itraconazole on Pathologic Complete Response Rates in Esophageal Cancer
A Phase II Trial Evaluating the Effectiveness of Itraconazole in Improving Pathologic Complete Response Rates in Patients With Esophageal Cancer Through Inhibition of the Hedgehog and AKT Signaling Pathways
Dallas VA Medical Center
78 participants
Jun 24, 2019
INTERVENTIONAL
Conditions
Summary
Esophageal cancer, which has a low 5-year overall survival rate for all stages (\<20%) , is increasing in incidence. Previous studies have shown that the Hedgehog (Hh) and AKT signaling pathways are activated in a significant proportion of esophageal cancers. Itraconazole, a widely used anti-fungal medication, has been shown to inhibit various pathways involved in esophageal cancer tumorigenesis including Hh and AKT. In this phase II clinical trial, the investigators aim to evaluate the effect of itraconazole as a neoadjuvant therapy following standard of care chemoradiation in the treatment of locoregional esophageal and gastroesophageal junction carcinomas.
Eligibility
Inclusion Criteria2
- Patients diagnosed with localized (locoregional) esophageal cancer
- Patients diagnosed with localized (locoregional) gastroesophageal junction cancer
Exclusion Criteria6
- Patients unwilling or unable to provide informed consent
- Patients with QTc\>450ms
- Patients with a history of symptomatic congestive heart failure
- Patients with LFT's\>3xULN
- Patients who are pregnant
- Patients with a known allergy to itraconazole
Interventions
Oral administration of itraconazole twice daily from completion of neoadjuvant chemoradiation until esophagectomy.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04018872