Study of 5-FU, Oxaliplatin, & Lapatinib Combined With Radiation Therapy to Treat HER2 Positive Esophagogastric Cancer

Phase 2 Terminated 12 enrolled SCRI Development Innovations, LLC GlaxoSmithKline · collab

NaSingle-groupOpen-labelTreatment

Summary

With improvements in response rate and survival seen for HER2 positive patients treated with HER2 blockade in the metastatic setting, the use of HER2 blockade in the neoadjuvant setting to increase antitumor effect shows promise. Patients with previously untreated localized HER2 positive esophageal, GE junction and gastric adenocarcinomas will be enrolled. Patients meeting all inclusion/exclusion criteria will receive neoadjuvant treatment with concurrent chemotherapy and radiation therapy beginning on day 1 of treatment. During the lead-in safety portion, the optimal dose of lapatinib will be determined.

Timeline

Start: 2013-02
Primary completion: 2014-02
Completion: 2015-02

Outcome

Outcome not reported

Stopped (Enrollment): “Study closed due to slow accrual.”

Publications

Shepard G, Arrowsmith ER, Murphy P, Barton JH Jr, Peyton JD, Mainwaring M, Blakely L, Maun NA, Bendell JC. A Phase II Study with Lead-In Safety Cohort of 5-Fluorouracil, Oxaliplatin, and Lapatinib in Combination with Radiation Therapy as Neoadjuvant Treatment for Patients with Localized HER2-Positive Esophagogastric Adenocarcinomas. Oncologist. 2017 Oct;22(10):1152-e98. doi: 10.1634/theoncologist.2017-0186. Epub 2017 Aug 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lapatinib	Small molecule	750 mg	Oral
Subject	Lapatinib	Small molecule	1000 mg	Oral
Subject	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	225 mg/m2	Intravenous