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

Phase 2
21 Years
Open (Enrolling)
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer

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Trial Information

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


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.

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

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

At week 12 of therapy

Safety Issue:


Principal Investigator

John P. Fruehauf, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Irvine


United States: Food and Drug Administration

Study ID:

UCI 10-11



Start Date:

December 2010

Completion Date:

June 2014

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Recurrent Prostate Cancer
  • Stage I Prostate Cancer
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer
  • Stage III Prostate Cancer
  • docetaxel
  • lycopene
  • prostate cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms



Chao Family Comprehensive Cancer Center Orange, California  92868