A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer

Part of paid clinical trials in Palo Alto, California.

Sponsor
VA Office of Research and Development
Study ID
NCT05563766
Phase
PHASE2
Status
Recruiting
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Conditions

  • Esophageal Adenocarcinoma
  • Esophageal Squamous Cell Carcinoma
  • Gastroesophageal Junction Carcinoma

Eligibility Criteria

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

Interventions

  • Itraconazole — DRUG
    Itraconazole 300 mg po bid for two weeks prior and 6-8 weeks after completion of standard of care neoadjuvant chemoradiation

Study Details

Esophageal cancer, which has a low 5-year overall survival rate (\<20%) is increasing in incidence. Previous studies have shown that Hedgehog, AKT, and angiogenic signaling pathways are activated in a significant number of esophageal cancers. Itraconazole, a widely used anti-fungal medication, effectively inhibits these pathways. In this multi-site phase II trial, the investigators will evaluate the effect of itraconazole as a neoadjuvant therapy added to standard of care chemoradiation and surgery in the the treatment of locoregional esophageal and gastroesophageal junction cancers.

Key Dates

Start date
Oct 1, 2024
Status verified
Nov 2025
Primary completion
Apr 30, 2029
Completion
Jun 15, 2029

Study Design

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

Arms

  • Experimental: Itraconazole
    Itraconazole 300 mg po bid for two weeks prior and 6-8 weeks after completion of standard of care neoadjuvant chemoradiation

Primary Outcome Measure

Rate of pathological complete response with itraconazole [ Time Frame: 20 weeks ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
VA Palo Alto Health Care System, Palo Alto, CAPalo AltoCalifornia94304-1207
Albert Lin, MD
[email protected]
650-493-5000
VA Ann Arbor Healthcare System, Ann Arbor, MIAnn ArborMichigan48105-2303
Laura A Randolph, BA
[email protected]
734-845-5091
David H Wang, MD PhD (PRINCIPAL_INVESTIGATOR)
Durham VA Medical Center, Durham, NCDurhamNorth Carolina27705-3875
Michael Kelley, MD
[email protected]
919-286-0411
VA Portland Health Care System, Portland, ORPortlandOregon97207-2964
Kenneth Bensch, MD
[email protected]
503-220-8262
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TXDallasTexas75216-7167
Nicole Pore-Brown
[email protected]
214-857-3291
Michael E. DeBakey VA Medical Center, Houston, TXHoustonTexas77030-4211
Yvonne Sada, MD
[email protected]
713-794-7454
VA Puget Sound Health Care System Seattle Division, Seattle, WASeattleWashington98108-1532
Daniel Wu, MD
[email protected]
206-764-2182

Find similar trials in Palo Alto, CA

By research site
VA Palo Alto Health Care System, Palo Alto, CA· Palo Alto, CAVA Ann Arbor Healthcare System, Ann Arbor, MI· Ann Arbor, MIDurham VA Medical Center, Durham, NC· Durham, NCVA Portland Health Care System, Portland, OR· Portland, ORVA North Texas Health Care System Dallas VA Medical Center, Dallas, TX· Dallas, TXMichael E. DeBakey VA Medical Center, Houston, TX· Houston, TX

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