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

Who is this study for? Adult patients with esophageal squamous cell carcinoma and other esophageal cancers
What treatments are being studied? Itraconazole
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Esophageal cancer, which has a low 5-year overall survival rate for all stages (\<20%) , is increasing in incidence. Previous studies have shown that the Hedgehog (Hh) and AKT signaling pathways are activated in a significant proportion of esophageal cancers. Itraconazole, a widely used anti-fungal medication, has been shown to inhibit various pathways involved in esophageal cancer tumorigenesis including Hh and AKT. In this phase II clinical trial, the investigators aim to evaluate the effect of itraconazole as a neoadjuvant therapy following standard of care chemoradiation in the treatment of locoregional esophageal and gastroesophageal junction carcinomas.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients diagnosed with localized (locoregional) esophageal cancer

• Patients diagnosed with localized (locoregional) gastroesophageal junction cancer

Locations
United States
Texas
Dallas VA Medical Center
RECRUITING
Dallas
Contact Information
Primary
David Wang, MD, PhD
davidh.wang@va.gov
214-857-0737
Backup
Thai Pham, MD
thai.pham2@va.gov
214-857-1800
Time Frame
Start Date: 2019-06-24
Estimated Completion Date: 2026-09-29
Participants
Target number of participants: 78
Treatments
Experimental: Itraconazole
Itraconazole capsule 300mg twice daily for 6-8 weeks following chemoradation.
Related Therapeutic Areas
Sponsors
Leads: Dallas VA Medical Center

This content was sourced from clinicaltrials.gov

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