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

Description

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.

Conditions

Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Gastroesophageal Junction Carcinoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Esophageal Adenocarcinoma
Intervention / Treatment

-

Contacts and Locations

Palo Alto

VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto, California, United States, 94304-1207

Ann Arbor

VA Ann Arbor Healthcare System, Ann Arbor, MI, Ann Arbor, Michigan, United States, 48105-2303

Durham

Durham VA Medical Center, Durham, NC, Durham, North Carolina, United States, 27705-3875

Portland

VA Portland Health Care System, Portland, OR, Portland, Oregon, United States, 97207-2964

Dallas

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX, Dallas, Texas, United States, 75216-7167

Houston

Michael E. DeBakey VA Medical Center, Houston, TX, Houston, Texas, United States, 77030-4211

Seattle

VA Puget Sound Health Care System Seattle Division, Seattle, WA, Seattle, Washington, United States, 98108-1532

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Capable of giving informed consent
  • * Pathologic diagnosis of esophageal cancer (ESCC or EAC) or GEJ cancer deemed resectable by a surgeon with a plan to undergo neoadjuvant chemoradiation and curative intent esophagectomy
  • * World Health Organization (WHO)/ECOG performance status (PS) of 0-2 at enrollment
  • * Adequate renal and liver function as judged by the treating physician
  • * Inability to provide Informed Consent
  • * NYHA class III or IV CHF
  • * LFT\>3X upper limit of normal
  • * Drug allergy to itraconazole
  • * Positive pregnancy test
  • * Those with QTc\>450 ms will have QTc monitored during therapy by serial EKG to ensure QTc does not lengthen to what the treating clinician considers significant

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VA Office of Research and Development,

David H Wang, MD PhD, PRINCIPAL_INVESTIGATOR, VA Ann Arbor Healthcare System, Ann Arbor, MI

Study Record Dates

2029-06-15