Evaluating the Effect of Itraconazole on Pathologic Complete Response Rates in Esophageal Cancer

Part of paid clinical trials in Dallas, Texas.

Sponsor
Dallas VA Medical Center
Study ID
NCT04018872
Phase
PHASE2
Status
Recruiting
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Conditions

  • Esophagus Adenocarcinoma
  • Esophagus Squamous Cell Carcinoma
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Itraconazole — DRUG
    Oral administration of itraconazole twice daily from completion of neoadjuvant chemoradiation until esophagectomy.

Study Details

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.

Key Dates

Start date
Jun 24, 2019
Status verified
Nov 2021
Primary completion
Jun 24, 2026
Completion
Sep 29, 2026

Study Design

Enrollment
78 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dallas VA Medical CenterDallasTexas75216
Jessica Vallejo, BSA
[email protected]
214-857-4237

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By research site
Dallas VA Medical Center· Dallas, TX

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