Study on the Effect of Itraconazole on Complete Response Rates in Esophageal Cancer

Sponsor: Dallas VA Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04018872

This clinical trial is exploring whether adding the antifungal drug itraconazole to standard chemoradiation treatment can improve outcomes for patients with esophageal and gastroesophageal junction cancer.

Patient Parameters

Program Overview

Esophageal cancer is becoming more common and has a low survival rate. This study is testing if itraconazole, a common antifungal medication, can help improve treatment results when used with standard chemoradiation therapy for esophageal and gastroesophageal junction cancers. Itraconazole may block certain pathways that help cancer grow. The trial will see if this approach increases the number of patients whose cancer completely responds to treatment.

Description

This study is investigating a new approach to treating esophageal cancer, which is on the rise in the United States. Researchers are testing if itraconazole, a drug usually used to treat fungal infections, can help stop cancer growth by blocking specific pathways in cancer cells. The study aims to see if adding itraconazole to the usual chemoradiation treatment can increase the number of patients whose cancer completely disappears after treatment.

About 78 patients with esophageal or gastroesophageal junction cancer will participate. They will first undergo standard tests, including PET/CT scans and endoscopic ultrasound, to check the cancer's status. Some patients will have biopsies to examine certain cancer pathways before treatment. If the cancer hasn't spread, patients will receive 5-6 weeks of standard chemoradiation therapy. Afterward, they will take itraconazole twice daily for 6-8 weeks. Doctors will monitor for any side effects.

If follow-up scans show no new cancer spread, patients will have surgery to remove the esophagus (esophagectomy). Researchers will analyze tissue samples to check for itraconazole and its effects on cancer pathways. The study will determine if the cancer has completely responded to treatment. Researchers hope that itraconazole will improve treatment success by blocking pathways that help cancer resist chemoradiation.

Eligibility Criteria

Inclusion Criteria

  • Patients with localized esophageal cancer
  • Patients with localized gastroesophageal junction cancer

Exclusion Criteria

  • Unable or unwilling to provide consent
  • Heart rhythm issues (QTc > 450ms)
  • History of heart failure with symptoms
  • Liver function tests more than 3 times the normal limit
  • Pregnant patients
  • Known allergy to itraconazole

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