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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of California, Irvine
Sponsor:
Information provided by (Responsible Party):
Chao Family Comprehensive Cancer Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01882985
First received: June 18, 2013
Last updated: January 30, 2014
Last verified: January 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Time to PSA progression [ Time Frame: Estimated using Kaplan-Meier methods ] [ Designated as safety issue: No ]
    Up to 4 years

  • Toxicity of combined docetaxel + lycopene therapy [ Time Frame: Up to 4 years ] [ Designated as safety issue: Yes ]
    The percentage of subjects experiencing grade 3-4 hematologic and non-hematologic toxicity will be recorded, as well as the reason for ending treatment.


Estimated Enrollment: 40
Study Start Date: December 2010
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2018 (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

Ages Eligible for Study:   21 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882985

Locations
United States, California
Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
Contact: Chao Family Comprehensive Cancer Center University of California, Irvine Medical Center    877-827-8839    UCstudy@uci.edu   
Principal Investigator: John P. Fruehauf, MD, PhD         
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: John P. Fruehauf, MD, PhD University of California, Irvine
  More Information

No publications provided

Responsible Party: Chao Family Comprehensive Cancer Center, Cancer Center, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01882985     History of Changes
Other Study ID Numbers: UCI 10-11, 2010-7765, NCI-2011-00037
Study First Received: June 18, 2013
Last Updated: January 30, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of California, Irvine:
docetaxel
lycopene
prostate cancer

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

ClinicalTrials.gov processed this record on November 20, 2014