Recruiting
Phase 2

Itraconazole

Sponsor:

Dallas VA Medical Center

Code:

NCT04018872

Conditions

Esophagus Adenocarcinoma

Esophagus Squamous Cell Carcinoma

Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Itraconazole

Study Details

Brief 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.

Conditions

Esophagus Adenocarcinoma

Esophagus Squamous Cell Carcinoma

Gastroesophageal Junction Adenocarcinoma

Study ID

NCT04018872

Start date

Jun 24, 2019

Status verified date

Nov, 2021

Completion date

Sep 29, 2026

Anticipated

Primary completion date

Jun 24, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients diagnosed with localized (locoregional) esophageal cancer
  • Patients diagnosed with localized (locoregional) gastroesophageal junction cancer

Exclusion Criteria:

  • Patients unwilling or unable to provide informed consent
  • Patients with QTc>450ms
  • Patients with a history of symptomatic congestive heart failure
  • Patients with LFT's>3xULN
  • Patients who are pregnant
  • Patients with a known allergy to itraconazole

Study Design

Enrollment

78 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Itraconazole

Itraconazole capsule 300mg twice daily for 6-8 weeks following chemoradation.

Interventions

Itraconazole

Oral administration of itraconazole twice daily from completion of neoadjuvant chemoradiation until esophagectomy.

Primary outcome measure

  • Percentage of pathological complete response with itraconazole [ Time Frame: 3-4 months ]

Central Contacts and Locations

Central contacts

Locations

Dallas VA Medical Center

Recruiting

Dallas, Texas, United States, 75216

Contacts

More Information

Sponsor

Dallas VA Medical Center

Last update posted

Nov 4, 2021

Last verified

Nov, 2021

Keywords

  • itraconazole
  • esophageal neoplasms
  • esophagus
  • esophagogastric junction
  • adenocarcinoma
  • squamous cell carcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Dallas VA Medical Center on 2021-11-04.