A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

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

• 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

Locations
United States
California
VA Palo Alto Health Care System, Palo Alto, CA
RECRUITING
Palo Alto
Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
NOT_YET_RECRUITING
Ann Arbor
North Carolina
Durham VA Medical Center, Durham, NC
RECRUITING
Durham
Oregon
VA Portland Health Care System, Portland, OR
RECRUITING
Portland
Texas
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
RECRUITING
Dallas
Michael E. DeBakey VA Medical Center, Houston, TX
RECRUITING
Houston
Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
RECRUITING
Seattle
Contact Information
Primary
David H Wang, MD PhD
davidh.wang@va.gov
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2029-06-15
Participants
Target number of participants: 78
Treatments
Experimental: Itraconazole
Itraconazole 300 mg po bid for two weeks prior and 6-8 weeks after completion of standard of care neoadjuvant chemoradiation
Related Therapeutic Areas
Sponsors
Collaborators: VA Ann Arbor Healthcare System, VA Puget Sound Health Care System, Durham VA Health Care System, Michael E. DeBakey VA Medical Center, VA Boston Healthcare System, North Texas Veterans Healthcare System, VA Palo Alto Health Care System, Portland VA Medical Center
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov