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

Description

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.

Conditions

Esophagus Adenocarcinoma, Esophagus Squamous Cell Carcinoma, Gastroesophageal Junction Adenocarcinoma

Study Overview

Study Details

Study overview

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.

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

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

Condition
Esophagus Adenocarcinoma
Intervention / Treatment

-

Contacts and Locations

Dallas

Dallas VA Medical Center, Dallas, Texas, United States, 75216

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dallas VA Medical Center,

David Wang, MD, PhD, PRINCIPAL_INVESTIGATOR, North Texas Veterans Healthcare System

Study Record Dates

2026-09-29