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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01882985
First Posted: June 21, 2013
Last Update Posted: December 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
John P. Fruehauf, University of California, Irvine
  Purpose
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.

Condition Intervention 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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Evaluate the Effects of Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Naïve Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by John P. Fruehauf, University of California, Irvine:

Primary Outcome Measures:
  • PSA response (proportion of subjects achieving a >= 50% reduction in PSA from baseline) [ Time Frame: At week 12 of therapy ]
    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.


Secondary Outcome Measures:
  • 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.


Enrollment: 14
Study Start Date: December 2010
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Docetaxel
Given IV
Other Names:
  • 114977-28-5
  • 40466
  • 628503
  • RP 56976
  • RP56976
  • Taxotere
  • TXT
Dietary Supplement: Lycopene
Given PO
Other Names:
  • 407322
  • 502-65-8
  • all-trans-Lycopene
  • Lyc-O-Mato
  • LYCO
  • psi
  • psi-Carotene

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, California
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: John P. Fruehauf, MD, PhD University of California, Irvine
  More Information

Responsible Party: John P. Fruehauf, Professor of Clinical Medicine, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01882985     History of Changes
Other Study ID Numbers: UCI 10-11
2010-7765 ( Other Identifier: University of Calfornia, Irvine )
NCI-2011-00037 ( Other Identifier: NCI Clinical Trials Reporting Program )
First Submitted: June 18, 2013
First Posted: June 21, 2013
Last Update Posted: December 8, 2016
Last Verified: November 2016

Keywords provided by John P. Fruehauf, University of California, Irvine:
docetaxel
lycopene
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Docetaxel
Lycopene
Carotenoids
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents