Testing the Addition of an Anti-cancer Drug, Adavosertib, to Radiation Therapy for Patients With Incurable Esophageal and Gastroesophageal Junction Cancers

Summary

This phase I trial investigates the side effects and best dose of adavosertib and how well it works when given in combination with radiation therapy in treating patients with esophageal or gastroesophageal junction cancer for which no treatment is currently available (incurable). Adavosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving adavosertib together with radiation therapy kill more tumor cells than radiation therapy alone in treating patients with esophageal and gastroesophageal junction cancer.

Conditions

• Clinical Stage III Esophageal Adenocarcinoma AJCC v8
• Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8
• Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
• Clinical Stage IV Esophageal Adenocarcinoma AJCC v8
• Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
• Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
• Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8
• Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
• Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
• Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8
• Clinical Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8
• Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
• Distal Esophagus Adenocarcinoma
• Gastric Cardia Adenocarcinoma
• Metastatic Esophageal Adenocarcinoma
• Metastatic Esophageal Squamous Cell Carcinoma
• Metastatic Gastroesophageal Junction Adenocarcinoma
• Metastatic Malignant Neoplasm in the Brain
• Metastatic Malignant Neoplasm in the Leptomeninges
• Pathologic Stage III Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8
• Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8
• Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8
• Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage IV Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
• Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
• Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8
• Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage III Esophageal Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage III Esophageal Squamous Cell Carcinoma AJCC v8
• Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IIIA Esophageal Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8
• Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IIIB Esophageal Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8
• Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IV Esophageal Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
• Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
• Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8
• Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
• Unresectable Esophageal Adenocarcinoma
• Unresectable Esophageal Carcinoma
• Unresectable Esophageal Squamous Cell Carcinoma
• Unresectable Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

Adavosertib

Given PO

RADIATION

Radiation Therapy

Undergo radiation therapy

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Eric D Miller · Ohio State University Comprehensive Cancer Center LAO

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-09

Primary Completion

2024-03-29

Completion

2026-12-18

FDA Drug

Yes

Countries

• United States

Study Locations