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

Recruiting now · Phase 2

Conditions studied: Esophagus Adenocarcinoma, Esophagus Squamous Cell Carcinoma, Gastroesophageal Junction Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT04018872

Run by

Dallas VA Medical Center

People needed

78

Starts

2019-06-24

Expected to finish

2026-09-29

Last updated by the study team

2021-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Dallas VA Medical Center — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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