A Phase II Study to Evaluate the Effects of Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Naïve Prostate Cancer Patients
I. To define the prostate-specific antigen (PSA) response rate according to the criteria of
Bubley, et al., in subjects treated with a combination of docetaxel and lycopene.
I. To determine the objective response rate (ORR) according to modified Response Evaluation
Criteria In Solid Tumors (RECIST) criteria in patients with measurable disease, following
treatment with docetaxel and lycopene.
II. To define the time to PSA progression, according to the response criteria of Scher, et
al., in subjects treated with docetaxel and lycopene.
III. To determine the safety and tolerability of lycopene in combination with docetaxel.
IV. To determine the effects of docetaxel + lycopene therapy on the functioning of the
insulin-like growth factor receptor (IGFRI), selected biomarkers, and docetaxel blood levels
in plasma and peripheral blood mononuclear cells (correlative studies).
Patients receive docetaxel intravenously (IV) over 1 hour on day 2 and lycopene orally (PO)
once daily on days 1-21. Treatment repeats every 21days for at least 4 courses in the
absence of disease progression or unacceptable toxicity.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA response (proportion of subjects achieving a >= 50% reduction in PSA from baseline)
Data analysis for the primary endpoint will involve estimation of the PSA response rate (and 95% confidence interval) defined as the proportion of subjects achieving a >= 50% reduction in PSA from a baseline value of at least 2ng/ml at any point after the start of treatment. 95% confidence intervals will be estimated.
At week 12 of therapy
John P. Fruehauf, MD, PhD
University of California, Irvine
United States: Food and Drug Administration
|Chao Family Comprehensive Cancer Center||Orange, California 92868|