A phase I study of docetaxel plus synthetic lycopene in metastatic prostate cancer patients.

ABSTRACT:

Purpose

Our preclinical studies showed that lycopene enhanced the anti-prostate cancer efficacy of docetaxel in animal models. A phase I trial (NCT0149519) was conducted to identify an optimum dose of synthetic lycopene in combination with docetaxel (and androgen blockade [androgen deprivation therapy, ADT]), and to evaluate its effect on the safety and pharmacokinetics of docetaxel in men with metastatic prostate cancer.

Methods

Subjects were treated with 21-day cycles of 75 mg/m² docetaxel (and ADT), plus lycopene at 30, 90 or 150 mg/day. A Bayesian model averaging continual reassessment method was used to guide dose escalation. Pharmacokinetics of docetaxel and multiple correlative studies were carried out.

Results

Twenty-four participants were enrolled,

SUBMITTER: Lilly MB 

PROVIDER: S-EPMC10958125 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature