Evaluating Itraconazole for Treating Esophageal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial investigates the effects of itraconazole, an antifungal medication, on improving pathologic complete response rates in patients with resectable esophageal and gastroesophageal junction cancers. The study aims to determine if adding itraconazole to standard neoadjuvant chemoradiation and surgery can enhance treatment outcomes. A total of 78 patients will be enrolled, and those without distant metastases will receive itraconazole before and after chemoradiation. The trial will monitor adverse effects and drug compliance through tissue analysis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 or perioperative chemoimmunotherapy and curative intent esophagectomy
* World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 at enrollment
* Adequate renal and liver function as judged by the treating physician

Exclusion Criteria:

* Inability to provide Informed Consent
* New York Heart Association (NYHA) class III or IV congestive heart failure (CHF)
* LFT\>3X upper limit of normal
* Drug allergy to itraconazole
* Positive pregnancy test
* Those with QTc\>450 milliseconds (ms) will have QTc monitored during therapy by serial EKG to ensure QTc does not lengthen to what the treating clinician considers significant

Where it's running

• VA Palo Alto Health Care System, Palo Alto, CA
  Palo Alto, California, United States Recruiting
• VA Ann Arbor Healthcare System, Ann Arbor, MI
  Ann Arbor, Michigan, United States Recruiting
• Durham VA Medical Center, Durham, NC
  Durham, North Carolina, United States Recruiting
• VA Portland Health Care System, Portland, OR
  Portland, Oregon, United States Recruiting
• VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
  Dallas, Texas, United States Recruiting
• Michael E. DeBakey VA Medical Center, Houston, TX
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: David H Wang, MD PhD — VA Ann Arbor Healthcare System, Ann Arbor, MI
• Study coordinator: David H Wang, MD PhD
• Email: davidh.wang@va.gov

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.