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Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Naïve Prostate Cancer Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Naïve Prostate Cancer Patients

A Phase II Study to Evaluate the Effects of Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Naïve Prostate Cancer Patients

NCT01882985•University of California, Irvine

View on ClinicalTrials.gov

Summary

This phase II trial evaluated the impact of giving docetaxel together with lycopene supplements in treating patients with hormone-resistant prostate cancer not previously treated with chemotherapy. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoprevention is the use of certain drugs, such as lycopene, to keep cancer from forming. Giving docetaxel together with lycopene may be an effective treatment for prostate cancer.

Detailed Description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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). OUTLINE: 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.

Eligibility

Age

21 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Patient must have a histological diagnosis of adenocarcinoma of the prostate and 2 rising pre-study PSA values \>= 1 ng/ml at least 1 week apart within 28 days prior to enrollment
•Patients must be unresponsive to androgen-deprivation therapy (ADT), as indicated by a rising PSA level above the ADT nadir
•Patient must not have received chemotherapy, biologic therapy, or any other investigational drug for any reason within 28 days prior to start of therapy, and must have recovered from toxicities of prior therapy to grade 1 or less
•Patients must have been surgically or medically castrated; if the patient is being treated with medical castration, he must be willing to continue this treatment for the duration of the study; ADT should not be initiated, terminated, or dose-adjusted during the study
•Prior external beam radiation therapy (to less than 30% of the bone marrow only) is allowed; at least 28 days must have elapsed since the completion of radiation therapy and the patient must have recovered from side effects; prior treatment with samarium-153 or strontium-86 is allowed if at least eight weeks have elapsed since dosing, and all toxicities have resolved to grade 1; soft tissue disease which has been radiated in the prior 2 months is not assessable as measurable disease
•Patients may have received prior surgery; however, at least 21 days must have elapsed since completion of surgery and the patient must have recovered from all side effects
•Normal serum bilirubin and serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvate transaminase (SGPT) =\< 1.5 x the institutional upper limit of normal obtained within 14 days prior to start of therapy; liver function tests should be evaluated prior to each treatment
•Serum creatinine =\< 1.5 x the institutional upper limit of normal obtained within 14 days prior to start of therapy
•Men of child bearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
•Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
+7 more criteria

Exclusion Criteria

•Uncontrolled brain or spinal cord metastases
•History of congestive heart failure or myocardial infarction within the previous six months
•History of allergy or hypersensitivity to any component of the study drugs
•Evidence or history of a bleeding diathesis or coagulopathy, including therapy-induced coagulopathy
•Presence of chronic diarrhea (\> grade 1 by Common Toxicity Criteria (CTC)), short bowel syndrome, pancreatic insufficiency, or malabsorption
•Presence of any severe or uncontrolled concurrent medical condition which, in the opinion of the investigator, would increase the risk of serious toxicity from the study drugs
•Concurrent use of any vitamin, herb, or mineral supplements for at least 14 days prior to start of therapy

Locations (1)

Chao Family Comprehensive Cancer Center

Orange, California, United States

Key Dates

Start Date

December 1, 2010

Primary Completion Date

October 1, 2016

Completion Date

October 1, 2016

Last Updated

January 5, 2021

Enrollment

ACTUAL participants

Conditions

Adenocarcinoma of the ProstateRecurrent Prostate CancerStage I Prostate CancerStage IIA Prostate CancerStage IIB Prostate CancerStage III Prostate Cancer

Interventions

Docetaxel

DRUG

Lycopene

DIETARY_SUPPLEMENT

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Naïve Prostate Cancer Patients

Inclusion Criteria

Exclusion Criteria

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial

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