Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Naïve Prostate Cancer Patients
Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Dietary Supplement: Lycopene
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study to Evaluate the Effects of Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Naïve Prostate Cancer Patients|
- PSA response (proportion of subjects achieving a >= 50% reduction in PSA from baseline) [ Time Frame: At week 12 of therapy ]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.
- Objective response rate as assessed by RECIST criteria in either visceral or lymph node metastases [ Time Frame: Up to 4 years ]The percent of subjects achieving an objective response by RECIST criteria in either visceral or lymph node metastases, and the percent achieving clinical complete disappearance of disease at any site, will be recorded.
- Time to PSA progression [ Time Frame: Up to 4 years ]The definition of time to PSA progression is the date (after the initiation of chemotherapy on day 2) that a 25% or greater increase, and an absolute increase of 2ng/mL or more, from the nadir PSA is documented. If there is no decrease in PSA following chemotherapy, then PSA progression is the date for documentation of a 25% increase from the baseline value along with an increase in absolute value of 2ng/mL or more.
- Toxicity of combined docetaxel + lycopene therapy [ Time Frame: Up to 4 years ]The percentage of subjects experiencing grade 3-4 hematologic and non-hematologic toxicity will be recorded, as well as the reason for ending treatment.
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||November 2017|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
Experimental: Treatment (docetaxel and lycopene)
Patients receive docetaxel IV over 1 hour on day 2 and lycopene 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.
Other Names:Dietary Supplement: Lycopene
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01882985
|United States, California|
|Chao Family Comprehensive Cancer Center|
|Orange, California, United States, 92868|
|Principal Investigator:||John P. Fruehauf, MD, PhD||University of California, Irvine|