A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

Esophageal cancer, which has a low 5-year overall survival rate (\<20%) is increasing in incidence. Previous studies have shown that Hedgehog, AKT, and angiogenic signaling pathways are activated in a significant number of esophageal cancers. Itraconazole, a widely used anti-fungal medication, effectively inhibits these pathways. In this multi-site phase II trial, the investigators will evaluate the effect of itraconazole as a neoadjuvant therapy added to standard of care chemoradiation and surgery in the the treatment of locoregional esophageal and gastroesophageal junction cancers.

Eligibility criteria

Qualifiers

Capable of giving informed consent

Pathologic diagnosis of esophageal cancer (ESCC or EAC) or GEJ cancer deemed resectable by a surgeon with a plan to undergo neoadjuvant chemoradiation and curative intent esophagectomy

World Health Organization (WHO)/ECOG performance status (PS) of 0-2 at enrollment

Adequate renal and liver function as judged by the treating physician

Disqualifiers

Inability to provide Informed Consent

NYHA class III or IV CHF

LFT>3X upper limit of normal

Drug allergy to itraconazole

Trial design

Treatments tested in this trial

  • Itraconazole

Treatment groups

78 Participants
are divided into 1 treatment group

Sponsors and collaborators

VA Office of Research and Development

Lead sponsor

Durham VA Health Care System

Collaborator

VA Palo Alto Health Care System

Collaborator

Portland VA Medical Center

Collaborator

VA Puget Sound Health Care System

Collaborator

Michael E. DeBakey VA Medical Center

Collaborator

VA Boston Healthcare System

Collaborator

North Texas Veterans Healthcare System

Collaborator

VA Ann Arbor Healthcare System

Collaborator