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Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Na�ve Prostate Cancer Patients

Information source: University of California, Irvine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer

Intervention: Docetaxel (Drug); Lycopene (Dietary Supplement)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of California, Irvine

Official(s) and/or principal investigator(s):
John P. Fruehauf, MD, PhD, Principal Investigator, Affiliation: University of California, Irvine


This phase II trial is studying how well giving docetaxel together with lycopene works 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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: PSA response (proportion of subjects achieving a >= 50% reduction in PSA from baseline)

Secondary outcome:

Objective response rate as assessed by RECIST criteria in either visceral or lymph node metastases

Time to PSA progression

Toxicity of combined docetaxel + lycopene therapy

Detailed description: PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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). OUTLINE: 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.


Minimum age: 21 Years. Maximum age: N/A. Gender(s): Male.


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

- 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

- Patients must be able to take oral medications

- All patients must be informed and must sign and give written informed consent in

accordance with institutional and federal guidelines; patients who are unable to comply with study and/or follow-up procedures are ineligible Exclusion Criteria:

- Uncontrolled brain or spinal cord metastases

- History of congestive heart failure or myocardial infarction within the previous six


- 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 and Contacts

Chao Family Comprehensive Cancer Center, Orange, California 92868, United States; Recruiting
Chao Family Comprehensive Cancer Center University of California, Irvine Medical Center, Phone: 877-827-8839, Email: UCstudy@uci.edu
John P. Fruehauf, MD, PhD, Principal Investigator
Additional Information

Starting date: December 2010
Last updated: January 30, 2014

Page last updated: August 23, 2015

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