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Evaluating the Effect of Itraconazole on Pathologic Complete Response Rates in Esophageal Cancer

RECRUITINGPhase 2Sponsored by Dallas VA Medical Center
Actively Recruiting
PhasePhase 2
SponsorDallas VA Medical Center
Started2019-06-24
Est. completion2026-06-24
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Patients diagnosed with localized (locoregional) esophageal cancer
* Patients diagnosed with localized (locoregional) gastroesophageal junction cancer

Exclusion Criteria:

* 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

Conditions4

CancerEsophagus AdenocarcinomaEsophagus Squamous Cell CarcinomaGastroesophageal Junction Adenocarcinoma

Locations1 site

Dallas VA Medical Center
Dallas, Texas, 75216
Jessica Vallejo, BSA

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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