NCT01949519

Docetaxel and Lycopene in Metastatic Prostate Cancer

A Phase I Study of Docetaxel Plus Synthetic Lycopene in Metastatic Prostate Cancer Patients With Biochemical or Clinical Relapse

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adenocarcinoma of the Prostate

Interventions

Type	Name	Description
DRUG	Lycopene and Docetaxel	During administration of standard of care Docetaxel at 75 mg/m2 on day 15 and every 21 days, study patients will also receive Lycopene at the dose specified per the dose cohort they are enrolled. There are three dose cohort levels as follows: Dose level 1 = 30 mg PO every day; Dose level 2 = 90 mg PO every day; Dose level 3 = 150 mg PO every day.Treatment will continue until disease progression or toxicity or patient withdrawal.

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-06-01
• Completion: 2017-07-12
• First posted: 2013-09-24
• Last updated: 2018-01-11

Locations

2 sites across 1 country: United States