A Phase 1 Study of NBTXR3 Activated by Radiotherapy With Concurrent Chemotherapy for Adenocarcinoma of the Esophagus
M.D. Anderson Cancer Center
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.
Description
PRIMARY OBJECTIVE: I. To determine the recommended phase II dose (RP2D) of hafnium oxide-containing nanoparticles NBTXR3 (NBTXR3) activated by radiotherapy with concurrent chemotherapy, per standard of care, for treatment naive patients with adenocarcinoma of the esophagus. SECONDARY OBJECTIVES: I. To evaluate the safety and feasibility of radiation with NBTXR3 in patients with adenocarcinoma of the esophagus. II. To evaluate the anti-tumor response of chemoradiation with NBTXR3 in patients with adenocarcinoma of the esophagus. III. To evaluate time-to-event outcomes after chemoradiation…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Biopsy proven adenocarcinoma of the cervical or thoracic esophagus or gastroesophageal junction * Adenocarcinoma of the esophagus stages II-III allowed * Medically able to receive chemoradiation. Following chemotherapy regimens are allowed: * Oxaliplatin and fluorouracil (5-FU) or capecitabine * Docetaxel and/or 5-FU or paclitaxel * Carboplatin and paclitaxel * Amenable to undergo the endoscopic ultrasound (EUS) guided injection of NBTXR3 as determined by the investigator or treating physician * Patients with lesions for which the EUS scope is not able to trave…
Interventions
- DrugCapecitabine
Not applicable to this study
- DrugCarboplatin
Not applicable to this study
- DrugDocetaxel
Not applicable to this study
- DrugFluorouracil
Not applicable to this study
- OtherHafnium Oxide-containing Nanoparticles NBTXR3
Given IT or IN
- RadiationIntensity-Modulated Radiation Therapy
Undergo IMRT
- DrugLeucovorin
Not applicable to this study
Location
- M D Anderson Cancer CenterHouston, Texas