Itraconazole Exerts Its Antitumor Effect in Esophageal Cancer By Suppressing the HER2/AKT Signaling Pathway.
Wei Zhang, Ankur S Bhagwath, Zeeshan Ramzan...
https://pubmed.ncbi.nlm.nih.gov/34376577Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID05563766
A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer
Led by VA Office of Research and Development · Updated on 2025-11-05
78
Participants Needed
7
Research Sites
6 weeks
Total Duration
On this page
Sponsors
V
VA Office of Research and Development
Lead Sponsor
D
Durham VA Health Care System
Collaborating Sponsor
AI-Summary
What this Trial Is About
Esophageal cancer, including esophageal adenocarcinoma, squamous cell carcinoma, and gastroesophageal junction carcinoma, has a low five-year survival rate under 20% and is becoming more common. Researchers are studying whether adding itraconazole, an antifungal medication that blocks certain cancer growth pathways, to the usual treatment of chemoradiation and surgery can improve outcomes. This phase II trial aims to see if itraconazole increases the rate of complete tumor disappearance after treatment in patients with resectable esophageal or gastroesophageal junction cancer. Patients will first have standard cancer staging with PET/CT scans and endoscopic ultrasound to check for spread. If no distant cancer is found, they will take oral itraconazole twice daily for two weeks before starting standard neoadjuvant chemoradiation. After completing chemoradiation, patients will continue itraconazole for 6 to 8 weeks. Following treatment, if scans show no new metastases, patients will undergo surgery to remove the esophagus. Throughout the study, itraconazole levels and side effects will be monitored to assess adherence and safety. Participants will have tissue samples collected before and after treatment to analyze the activity of cancer growth pathways and measure drug levels. Blood samples will also be tested for circulating tumor DNA and exosomes as markers of response. The main outcome is the rate of pathologic complete response at about 20 weeks. Secondary goals include correlating drug levels with outcomes and developing genetic profiles to predict treatment response. This study lasts from initial staging through surgery and follow-up assessments.
CONDITIONS
Brief Title
A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Able to give informed consent
- Diagnosed with resectable esophageal squamous cell carcinoma, esophageal adenocarcinoma, or gastroesophageal junction cancer
- Planned treatment includes neoadjuvant chemoradiation and curative esophagectomy
- Performance status of 0 to 2 according to WHO/ECOG
- Adequate kidney and liver function as determined by the treating physician
You will not qualify if you...
- Unable to provide informed consent
- New York Heart Association (NYHA) class III or IV congestive heart failure
- Liver function tests greater than three times the upper limit of normal
- Allergy to itraconazole
- Positive pregnancy test
- QTc interval greater than 450 ms with ongoing monitoring during therapy to prevent significant prolongation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Approximately 8 to 10 weeks
Participants take itraconazole orally twice daily for 2 weeks before starting neoadjuvant chemoradiation, then continue itraconazole for 6 to 8 weeks after completing chemoradiation.
Clinic visits for monitoring adverse effects and drug levels during itraconazole treatment
Surgery
Duration - Single surgical event with post-surgical care
Participants undergo esophagectomy if restaging shows no new metastases after chemoradiation.
1 visit for surgery and follow-up visits as needed
Trial Site Locations
Total: 7 locations
1
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1207
Actively Recruiting
2
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105-2303
Actively Recruiting
3
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705-3875
Actively Recruiting
4
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97207-2964
Actively Recruiting
5
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States, 75216-7167
Actively Recruiting
6
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030-4211
Actively Recruiting
7
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108-1532
Actively Recruiting
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Research Team
D
David H Wang, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Itraconazole, a commonly used antifungal that inhibits Hedgehog pathway activity and cancer growth.
James Kim, Jean Y Tang, Ruoyu Gong...
https://pubmed.ncbi.nlm.nih.gov/20385363Itraconazole-Induced Inhibition on Human Esophageal Cancer Cell Growth Requires AMPK Activation.
Min-Bin Chen, Yuan-Yuan Liu, Zhao-Yu Xing...
https://pubmed.ncbi.nlm.nih.gov/29592879Targeting the Hedgehog Pathway Using Itraconazole to Prevent Progression of Barrett's Esophagus to Invasive Esophageal Adenocarcinoma.
Ronan J Kelly, Amir M Ansari, Tomoharu Miyashita...
https://pubmed.ncbi.nlm.nih.gov/31290765