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:||Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Time to PSA progression [ Time Frame: Estimated using Kaplan-Meier methods ] [ Designated as safety issue: No ]Up to 4 years
- Toxicity of combined docetaxel + lycopene therapy [ Time Frame: Up to 4 years ] [ Designated as safety issue: Yes ]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:||June 2021|
|Estimated Primary Completion Date:||June 2018 (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||Recruiting|
|Orange, California, United States, 92868|
|Contact: Chao Family Comprehensive Cancer Center University of California, Irvine Medical Center 877-827-8839 UCstudy@uci.edu|
|Principal Investigator: John P. Fruehauf, MD, PhD|
|Principal Investigator:||John P. Fruehauf, MD, PhD||University of California, Irvine|