A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer
Recruiting now · Phase 2
Conditions studied: Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Gastroesophageal Junction Carcinoma
In brief
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.
Key facts
- Study ID
- NCT05563766
- Run by
- VA Office of Research and Development
- People needed
- 78
- Starts
- 2024-10-01
- Expected to finish
- 2029-06-15
- Last updated by the study team
- 2025-11-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States (enrolling)
- VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, United States (enrolling)
- Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States (enrolling)
- VA Portland Health Care System, Portland, OR — Portland, Oregon, United States (enrolling)
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States (enrolling)
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States (enrolling)
- VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States (enrolling)
Full record on ClinicalTrials.gov
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