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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDallas VA Medical Center

About this trial

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 criteria

Qualifiers

Patients diagnosed with localized (locoregional) esophageal cancer

Patients diagnosed with localized (locoregional) gastroesophageal junction cancer

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Itraconazole

Treatment groups

78 Participants
are divided into 1 treatment group

Sponsors and collaborators