Lapatinib and Bortezomib in Patients With Advanced Malignancies

Summary

This study is for patients with an advanced type of cancer for which no curative treatment exists. The purpose of this study is to test the safety and efficacy of the combination of the study drugs, lapatinib and bortezomib. Lapatinib is a drug that targets two proteins important for the growth of cancer cells known as HER1 (EGFR) and HER2. By inhibiting these proteins, lapatinib can inhibit cancer cell growth and even lead to their death. Lapatinib is an oral pill given by mouth once every day. Lapatinib is approved by the FDA for patients with breast cancer. Bortezomib is a drug that targets a part of cancer cells known as the proteosome. By inhibiting the proteosome, bortezomib can inhibit cancer cell growth and even lead to their death. Bortezomib is given intravenously, once a week, 2 out of every 3 weeks. Bortezomib is approved by the FDA for patients with multiple myeloma and mantle cell lymphoma. This research is being done because it is not known if the combination of lapatinib and bortezomib will work better than lapatinib or bortezomib alone, although in the lab and in animal studies the combination of the two drugs was much more effective than either drug alone. As part of this study biopsies will be taken of patients' tumors before any treatment, after starting lapatinib alone, and after receiving both lapatinib and bortezomib. Investigators want to study what markers inside tumors may relate to how well these two medications work. These biopsies are required as part of the study.

Timeline

Start

2011-09

Primary completion

2015-12

Completion

2015-12

Publications

• Lynce F, Wang H, Petricoin EF, Pohlmann PR, Smaglo B, Hwang J, He AR, Subramaniam DS, Deeken J, Marshall J, Pishvaian MJ. A phase I study of HER1, HER2 dual kinase inhibitor lapatinib plus the proteasome inhibitor bortezomib in patients with advanced malignancies. Cancer Chemother Pharmacol. 2019 Nov;84(5):1145-1151. doi: 10.1007/s00280-019-03947-7. Epub 2019 Sep 19.

Drugs

Indications