Evaluating itraconazole for treating esophageal cancer
A Phase II Trial Evaluating the Effectiveness of Itraconazole in Improving Pathologic Complete Response Rates in Patients With Esophageal Cancer Through Inhibition of the Hedgehog and AKT Signaling Pathways
This study is testing whether the antifungal medication itraconazole can help improve treatment outcomes for patients with esophageal cancer when used alongside standard chemotherapy and radiation.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dallas VA Medical Center Federal |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT04018872 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of itraconazole, an antifungal medication, as a neoadjuvant therapy in patients with locoregional esophageal cancer or gastroesophageal junction adenocarcinoma. The study aims to determine if itraconazole can improve the rates of pathological complete response (pathCR) following standard chemoradiation treatment. Approximately 78 patients will be enrolled and undergo standard staging work-ups, followed by chemoradiation and then itraconazole treatment. The trial will also assess the impact of itraconazole on specific cancer signaling pathways through biopsies and tissue analysis.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with localized esophageal cancer or gastroesophageal junction cancer.
Not a fit: Patients with distant metastases, significant heart conditions, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with esophageal cancer by increasing the rates of complete tumor response.
How similar studies have performed: While itraconazole has been studied for its effects on cancer pathways, this specific application in esophageal cancer is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with localized (locoregional) esophageal cancer * Patients diagnosed with localized (locoregional) gastroesophageal junction cancer Exclusion Criteria: * 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 * Patients who are pregnant * Patients with a known allergy to itraconazole
Where this trial is running
Dallas, Texas
- Dallas VA Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: David Wang, MD, PhD — North Texas Veterans Healthcare System
- Study coordinator: David Wang, MD, PhD
- Email: davidh.wang@va.gov
- Phone: 214-857-0737
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.