RecruitingPhase 2NCT04018872

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

Sponsor

Dallas VA Medical Center

Enrollment

78 participants

Start Date

Jun 24, 2019

Study Type

INTERVENTIONAL

Conditions

Gastroesophageal Junction Adenocarcinoma Esophagus Adenocarcinoma Esophagus Squamous Cell Carcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding itraconazole — an antifungal medication that may also block certain tumor growth pathways — to standard treatment before surgery for esophageal or stomach-esophagus junction cancer can help achieve a complete tumor response (where no cancer is found in the removed tissue). **You may be eligible if...** - You have been diagnosed with localized esophageal cancer or gastroesophageal junction cancer - Your cancer has not spread to distant organs - You are scheduled to receive standard pre-surgical treatment **You may NOT be eligible if...** - You have a prolonged QTc interval on your heart tracing (ECG) > 450ms - You have symptomatic heart failure - Your liver function tests are significantly elevated - You are pregnant - You have a known allergy to itraconazole - You are unable or unwilling to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGItraconazole

Oral administration of itraconazole twice daily from completion of neoadjuvant chemoradiation until esophagectomy.

Locations(1)

Dallas VA Medical Center

Dallas, Texas, United States

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NCT04018872

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