Docetaxel and Lycopene in Metastatic Prostate Cancer

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostatic Neoplasms

• NCT number: NCT01949519
• Study type: Interventional
• Source: Medical University of South Carolina
• Status: Completed
• Phase: Phase 1
• Start date: November 2013
• Completion date: July 12, 2017