Evaluating Itraconazole for Treating Esophageal Cancer
A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer
PHASE2 · VA Office of Research and Development · NCT05563766
This study is testing if adding the antifungal medication itraconazole to standard treatment can help improve outcomes for patients with operable esophageal cancer.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 7 sites (Palo Alto, California and 6 other locations) |
| Trial ID | NCT05563766 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with a pathologic diagnosis of resectable esophageal or gastroesophageal junction cancer who are eligible for neoadjuvant chemoradiation.
Not a fit: Patients with advanced heart failure, significant liver dysfunction, or those allergic to itraconazole may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with esophageal cancer.
How similar studies have performed: While itraconazole has been studied for other conditions, this specific application in esophageal cancer is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 Exclusion Criteria: * Inability to provide Informed Consent * NYHA class III or IV CHF * LFT\>3X upper limit of normal * Drug allergy to itraconazole * Positive pregnancy test * Those with QTc\>450 ms will have QTc monitored during therapy by serial EKG to ensure QTc does not lengthen to what the treating clinician considers significant
Where this trial is running
Palo Alto, California and 6 other locations
- 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)
- VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Gastroesophageal Junction Carcinoma, Itraconazole, Neoadjuvant