Adenocarcinoma of the Prostate Clinical Trial
Official title:
A Phase I Study of Docetaxel Plus Synthetic Lycopene in Metastatic Prostate Cancer Patients With Biochemical or Clinical Relapse
Docetaxel is the standard, first-line chemotherapeutic agent for castrate resistant prostate
cancer. While it has clinically useful activity, there is a strong need for substantial
improvement in its efficacy. Possible ways for improving docetaxel monotherapy would be to
combine it with an agent that either minimized toxicity (thus allowing higher doses) or
improves efficacy (by targeting synergistic pathways). Lycopene is an attractive agent for
combination with docetaxel because of its known accumulation in prostate tissue, its low
toxicity, and its ability to inhibit signaling through the IGF-1 axis, and to reduce IL6
levels. Lycopene is highly synergistic with docetaxel at inhibiting the growth of prostate
cancer in mice. The purpose of this study is to determine the maximum tolerated dose (MTD) of
lycopene given in combination with docetaxel. This dose can then be used for subsequent phase
II or phase III studies.
New findings from the ECOG E3805 study presented at ASCO 2014, showed that concurrent
chemotherapy with first-line ADT for newly diagnosed metastatic prostate cancer markedly
improved overall survival compared with delayed or no chemotherapy. These subjects could also
benefit from intervention to increase docetaxel effectiveness.
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