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

NCT01882985 | Completed Phase 2 Results DMC

• 3 other identifiers: UCI 10-11 [HS# 2010-7765]2010-7765NCI-2011-00037
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer

Keywords

docetaxel; lycopene; prostate cancer

Outcome Measures

Primary Outcomes (1)

• Proporation of Subjects Achieving Partial Response, Stable Disease or Progressive Disease Based on PSA Response Rates

  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. Per criteria of Bubley, et al., PSA response rate is defined the number of subjects who achieve a \>50% decline in PSA from baseline.

  Up to week 12 of therapy

Secondary Outcomes (3)

• Objective Response Rate as Assessed by RECIST Criteria in Either Visceral or Lymph Node Metastases

  Up to 4 years

• Time to PSA Progression

  Up to 4 years

• Toxicity of Combined Docetaxel + Lycopene Therapy

  Up to 4 years

Study Arms (1)

Treatment (docetaxel and lycopene)

EXPERIMENTAL

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.

Drug: Docetaxel; Dietary Supplement: Lycopene

Interventions

Docetaxel DRUG

Given IV

Also known as: 114977-28-5, 40466, 628503, RP 56976, RP56976, Taxotere, TXT

Treatment (docetaxel and lycopene)

Lycopene DIETARY_SUPPLEMENT

Given PO

Also known as: 407322, 502-65-8, all-trans-Lycopene, Lyc-O-Mato, LYCO, psi, psi-Carotene

Treatment (docetaxel and lycopene)

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Absolute neutrophil count \>= 1,500/microliter (mcL)
• Hemoglobin of \>= 8.0gm/dL
• White blood cell count \> 2,500/mcL
• Platelets \>= 100,000/mcL
• Patients with lower values may participate if, in the opinion of the investigator, the cytopenias are the result of bone marrow involvement with active prostate cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Lycopene

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Cyclohexenes; Cyclohexanes; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: Dr. John P. Fruehauf
• Organization: University of California, Irvine

jfruehau@uci.edu

714-456-5153

Study Officials

• John P. Fruehauf, MD, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 21, 2013
• Study Start: December 1, 2010
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: January 5, 2021
• Results First Posted: June 4, 2018

Record last verified: 2020-12

Locations

US (1)