Itraconazole for Esophageal Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What evidence supports the effectiveness of the drug itraconazole for esophageal cancer?
Research shows that itraconazole, a drug usually used to treat fungal infections, can slow down the growth of esophageal cancer cells by blocking certain proteins (HER2/AKT) that help cancer cells grow. It also activates a process (AMPK signaling) that leads to cancer cell death, which has been observed in both lab studies and early clinical trials.12345
How does the drug itraconazole differ from other treatments for esophageal cancer?
Itraconazole, originally an antifungal medication, is unique in treating esophageal cancer because it works by blocking specific pathways (HER2/AKT and AMPK) that help cancer cells grow. This mechanism is different from traditional chemotherapy or radiation, which do not specifically target these pathways.13678
What is the purpose of 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.
Research Team
David H Wang, MD PhD
Principal Investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
Eligibility Criteria
This trial is for individuals who can consent and have been diagnosed with resectable esophageal or gastroesophageal junction cancer, planning to undergo chemoradiation and surgery. They should be relatively active (WHO/ECOG status 0-2) and have good kidney and liver function.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-treatment with Itraconazole
Participants receive oral itraconazole for 2 weeks before starting standard of care neoadjuvant chemoradiation
Neoadjuvant Chemoradiation
Participants undergo standard of care neoadjuvant chemoradiation
Post-chemoradiation with Itraconazole
Participants receive oral itraconazole for 6-8 weeks after completion of chemoradiation
Surgery
Participants undergo esophagectomy if no new metastases are found
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Itraconazole
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
VA Puget Sound Health Care System
Collaborator
Michael E. DeBakey VA Medical Center
Collaborator
Portland VA Medical Center
Collaborator
VA Palo Alto Health Care System
Collaborator
VA Boston Healthcare System
Collaborator
North Texas Veterans Healthcare System
Collaborator
VA Ann Arbor Healthcare System
Collaborator
Durham VA Health Care System
Collaborator