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Itraconazole for Esophageal Cancer
Phase 2
Recruiting
Led By David Wang, MD, PhD
Research Sponsored by Dallas VA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients diagnosed with localized (locoregional) esophageal cancer
Patients diagnosed with localized (locoregional) gastroesophageal junction cancer
Must not have
Patients with a history of symptomatic congestive heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-4 months
Awards & highlights
Summary
This trial tests if itraconazole, a drug for fungal infections, can help treat esophageal cancer. It targets patients with poor survival rates. The drug works by blocking growth signals in cancer cells. The trial will see if adding itraconazole after standard treatment improves outcomes. Itraconazole is an FDA-approved antifungal agent that has shown promising anticancer activities in recent years.
Who is the study for?
This trial is for individuals with localized esophageal or gastroesophageal junction cancer. Participants must be able to consent, have normal heart rhythm (QTc ≤450ms), no severe heart failure history, liver function tests within three times the upper limit of normal, and not be pregnant or allergic to itraconazole.
What is being tested?
The study is testing if Itraconazole can improve outcomes when given before standard chemoradiation therapy in treating esophageal and gastroesophageal junction cancers. It's a phase II trial focusing on how this anti-fungal drug affects cancer pathways.
What are the potential side effects?
Itraconazole may cause side effects like nausea, rash, liver problems, heart issues such as congestive heart failure or abnormal heartbeat (QT prolongation), and could potentially interact with other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My esophageal cancer has not spread beyond the local area.
Select...
My cancer is located at the junction of the stomach and esophagus.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had heart failure symptoms in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-4 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of pathological complete response with itraconazole
Secondary study objectives
Comparison of hedgehog biomarkers before and after intervention
Comparison of phosphorylated VEGFR2 and AKT before and after intervention
Levels of itraconazole and metabolites in esophageal tissue
Side effects data
From 2015 Phase 1 & 2 trial • 178 Patients • NCT0197468738%
Headache
25%
Abdominal pain lower
13%
Arthralgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group F: Uprifosbuvir 300 mg (Tablet)
Group B: Uprifosbuvir 150 mg (Cohort 4b)
Group A: Uprifosbuvir 300 mg (Cohort 6a)
Groups C & D: Uprifosbuvir 300 mg (Capsule)
Group B: Uprifosbuvir 10 mg (Cohort 1b)
Group B: Uprifosbuvir 50 mg (Cohort 3b)
Groups C & D: Uprifosbuvir 150 mg (Capsule)
Groups C & D: Uprifosbuvir 400 mg (Capsule)
Group A: Uprifosbuvir 150 mg (Cohort 4a)
Group B: Uprifosbuvir 300 mg (Cohort 5b)
Groups C & D: Uprifosbuvir 50 mg (Capsule)
Groups C & D: Uprifosbuvir 300 mg (Tablet)
Group A: Placebo (Cohort 6a)
Group B: Uprifosbuvir 25 mg (Cohort 2b)
Groups C & D: Uprifosbuvir 250 mg (Capsule)
Group A: Placebo (Cohort 1a - Cohort 5a - Pooled)
Group A: Uprifosbuvir 10 mg (Cohort 1a)
Group A: Uprifosbuvir 25 mg (Cohort 2a)
Group A: Uprifosbuvir 50 mg (Cohort 3a)
Group A: Uprifosbuvir 300 mg (Cohort 5a)
Groups C & D: Uprifosbuvir 450 mg (Tablet)
Groups C & D: Placebo (Pooled)
Group E: Uprifosbuvir 150 mg (Cohort 1e)
Group E: Uprifosbuvir 300 mg (Cohort 2e)
Group E: Uprifosbuvir 450 mg (Cohort 3e)
Trial Design
1Treatment groups
Experimental Treatment
Group I: ItraconazoleExperimental Treatment1 Intervention
Itraconazole capsule 300mg twice daily for 6-8 weeks following chemoradation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itraconazole
2017
Completed Phase 2
~830
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Gastroesophageal Junction (GEJ) Adenocarcinoma often target specific signaling pathways crucial for cancer growth and survival. Itraconazole, for example, inhibits the Hedgehog (Hh) and AKT pathways, which are involved in tumorigenesis.
Chemoradiation, using drugs like fluorouracil and cisplatin, works by damaging DNA and inhibiting cell division. Targeted therapies, such as trastuzumab, focus on inhibiting growth signals specific to cancer cells, like HER2.
Understanding these mechanisms allows for personalized treatment plans that can more effectively target the cancer's specific pathways, improving outcomes for patients.
Targeted therapies with chemoradiation in esophageal cancer: development and future directions.
Targeted therapies with chemoradiation in esophageal cancer: development and future directions.
Find a Location
Who is running the clinical trial?
Dallas VA Medical CenterLead Sponsor
34 Previous Clinical Trials
4,758 Total Patients Enrolled
David Wang, MD, PhDPrincipal Investigator - North Texas Veterans Healthcare System
VA North Texas Health Care System-Dallas VA Medical Center
Vanderbilt University School Of Medicine (Medical School)
Johns Hopkins University School Medicine (Residency)
1 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My esophageal cancer has not spread beyond the local area.My cancer is located at the junction of the stomach and esophagus.You are allergic to itraconazole.I have had heart failure symptoms in the past.You are pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Itraconazole
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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