NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer
Trial Parameters
Brief 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.
Eligibility Criteria
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 traverse the tumor are allowed on this trial as long as an injection can be performed as per treating physician's discretion * Has at least 1 and up to 4 target lesion(s) in the esophagus that are measurable on cross sectional imaging and repeated measurements (via Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\] 1.1) at the same anatomical location should be achievable * Local nodal disease