NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer

Summary

The purpose of this Phase I study is to determine the recommended phase 2 dose (RP2D) and safety profile of NBTXR3 activated by radiation therapy with concurrent chemotherapy for the treatment of patients with esophageal adenocarcinoma. NBTXR3 is a drug that when activated by radiation therapy, may cause targeted destruction of cancer cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as oxaliplatin, fluorouracil, capecitabine, docetaxel, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving NBTXR3 activated by radiation therapy with concurrent chemotherapy may help control the disease.

Conditions

• Cervical Esophagus Adenocarcinoma
• Clinical Stage II Esophageal Adenocarcinoma AJCC v8
• Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8
• Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8
• Clinical Stage III Esophageal Adenocarcinoma AJCC v8
• Gastroesophageal Junction Adenocarcinoma
• Pathologic Stage II Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage III Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8
• Thoracic Esophagus Adenocarcinoma

Interventions

DRUG

Capecitabine

Not applicable to this study

DRUG

Carboplatin

Not applicable to this study

DRUG

Docetaxel

Not applicable to this study

DRUG

Fluorouracil

Not applicable to this study

OTHER

Hafnium Oxide-containing Nanoparticles NBTXR3

Given IT or IN

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

DRUG

Leucovorin

Not applicable to this study

DRUG

Oxaliplatin

Not applicable to this study

DRUG

Paclitaxel

Not applicable to this study

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Steven H Lin · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-23

Primary Completion

2027-10-31

Completion

2027-10-31

FDA Drug

Yes

Countries

• United States

Study Locations