Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Naïve Prostate Cancer Patients
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|ClinicalTrials.gov Identifier: NCT01882985|
Recruitment Status : Completed
First Posted : June 21, 2013
Results First Posted : June 4, 2018
Last Update Posted : June 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer||Drug: Docetaxel Dietary Supplement: Lycopene||Phase 2|
I. To define the prostate-specific antigen (PSA) response rate according to the criteria of Bubley, et al. (>50% reduction from baseline) in subjects treated with a combination of docetaxel and lycopene.
I.To determine the objective response rate (ORR) according to modified 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 IGFR-I, selected biomarkers, and docetaxel blood levels in plasma and peripheral blood mononuclear cells (correlative studies).
Patients receive 75 mg/m2 docetaxel intravenously (IV) over 1 hour q 21 days and lycopene 30 mg capsules orally (PO) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study to Evaluate the Effects of Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Naïve Prostate Cancer Patients|
|Actual Study Start Date :||December 2010|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
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.
Dietary Supplement: Lycopene
- Proporation of Subjects Achieving Partial Response, Stable Disease or Progressive Disease Based on PSA Response Rates [ Time Frame: At week 12 of therapy ]To define the prostate-specific antigen (PSA) response rate according to the criteria of Bubley, et al. (>50% reduction from bseline) in subjects treated with a combination of docetaxel and lycopene.
- 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. This outcome measure was not collected due to lack of funding.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|