Phase II Study on the Effect of Itraconazole in Treating Resectable Esophageal Cancer
Sponsor: VA Office of Research and Development
ClinicalTrials ID:NCT05563766
This clinical trial is exploring whether adding the antifungal drug itraconazole to standard treatment can improve outcomes for patients with esophageal cancer that can be surgically removed.
Patient Parameters
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Program Overview
Esophageal cancer is becoming more common and has a low survival rate. This study is testing if itraconazole, a drug usually used to treat fungal infections, can help improve treatment results when added to the usual chemotherapy and radiation before surgery for esophageal and gastroesophageal junction cancers. Itraconazole may block certain pathways that help cancer grow.
Description
This study is looking at a new way to treat esophageal cancer, which is a type of cancer that affects the tube connecting your throat to your stomach. The drug itraconazole, typically used to treat fungal infections, might help stop cancer growth by blocking certain pathways in the body. Researchers want to see if adding itraconazole to the usual treatment of chemotherapy and radiation before surgery can help more patients have no remaining cancer cells after treatment.
The study will include 78 patients with esophageal or gastroesophageal junction cancer. These patients will first have tests to check the stage of their cancer. If the cancer hasn't spread to distant parts of the body, they will take itraconazole for two weeks before starting chemotherapy and radiation. After these treatments, they will continue taking itraconazole for 6-8 weeks. Doctors will monitor for any side effects and check drug levels during clinic visits.
If follow-up scans show no new cancer spread, patients will have surgery to remove the cancer. Researchers will check tissue samples to see if itraconazole is present and if it affected the cancer pathways. They will compare these results to samples taken before treatment to see if the drug helped. The study aims to find out if itraconazole can improve treatment success and identify markers that predict how well patients respond to treatment.
Eligibility Criteria
Inclusion Criteria
- Able to give informed consent
- Diagnosed with esophageal or gastroesophageal junction cancer that can be surgically removed
- Plan to receive chemotherapy and radiation before surgery
- Good overall health with a performance status score of 0 to 2
- Adequate kidney and liver function as determined by the doctor
Exclusion Criteria
- Unable to give informed consent
- Severe heart failure (NYHA class III or IV)
- Liver function tests more than 3 times the normal limit
- Allergy to itraconazole
- Positive pregnancy test
- Heart rhythm issues (QTc over 450 ms) will be monitored during treatment to ensure safety
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | 94304-1207 | Palo Alto | California |
| VA Ann Arbor Healthcare System, Ann Arbor, MI | 48105-2303 | Ann Arbor | Michigan |
| Durham VA Medical Center, Durham, NC | 27705-3875 | Durham | North Carolina |
| VA Portland Health Care System, Portland, OR | 97207-2964 | Portland | Oregon |
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | 75216-7167 | Dallas | Texas |
| Michael E. DeBakey VA Medical Center, Houston, TX | 77030-4211 | Houston | Texas |
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | 98108-1532 | Seattle | Washington |
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