Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer

Summary

This Phase I trial combines ADI-PEG 20 with docetaxel in patients with advanced solid tumors with emphasis on castration resistant prostate cancer (CRPC). The investigators hypothesize that the combination will result in greater tumor cytotoxicity with an acceptable toxicity profile (i.e., manageable side effects) in cancer patients due to the unique mechanism of action of ADI-PEG 20. The investigators also hypothesize that the combination of ADI-PEG 20 and docetaxel will result in enhanced tumor cell apoptosis in part due to autophagy and that this will be particularly relevant in CRPC.

Timeline

Start

2011-09-06

Primary completion

2016-03-23

Completion

2018-08-31

Publications

• Background Kim RH, Coates JM, Bowles TL, McNerney GP, Sutcliffe J, Jung JU, Gandour-Edwards R, Chuang FY, Bold RJ, Kung HJ. Arginine deiminase as a novel therapy for prostate cancer induces autophagy and caspase-independent apoptosis. Cancer Res. 2009 Jan 15;69(2):700-8. doi: 10.1158/0008-5472.CAN-08-3157.

Drugs

Indications