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Adenocarcinoma of the ProstatePhase 1NCT01949519

Docetaxel and Lycopene in Metastatic Prostate Cancer

A Phase 1 study testing Lycopene and Docetaxel in people with Adenocarcinoma of the Prostate, run by Medical University of South Carolina at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Docetaxel is the standard, first-line chemotherapeutic agent for castrate resistant prostate cancer. While it has clinically useful activity, there is a strong need for substantial improvement in its efficacy. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Adenocarcinoma of the Prostate
What is being tested?
Lycopene and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesUnited States
Study dates
Nov 2013to 12 Jul 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have a histological diagnosis of adenocarcinoma of the prostate and 2 increasing pre-study PSA values, the last of which must be ≥1 ng/ml, at least 1 week apart.
  • Patients must have current or prior evidence of metastatic prostate cancer. Patients with radiographic evidence of disease progression but without PSA progression may also be eligible.
  • Subjects may have received prior chemotherapy except for a combination of docetaxel and lycopene. Prior chemotherapy must have been completed at least 1 year prior to start of treatment under this protocol. Prior biologic therapy, or any investigational drug must have been completed at least 28 days prior to start of therapy, and the patient must have recovered from toxicities of prior therapy to grade 1 or less.
  • Patients may or may not be surgically or medically castrated. If surgically or medically castrated, it would be documented by a testosterone level less than 50ng/mL. 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, radium-223, 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.
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  • Patient must have adequate hepatic function as defined by 1) a serum bilirubin ≤the institutional upper limit of normal (IULN), and 2) SGOT or SGPT ≤2.5 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.
  • Patients must have adequate renal function as defined by a 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.
  • Age > 18
  • Patient must have an ECOG performance status 0-2.
  • Patients must meet the following hematological criteria (minimal values):
  • Absolute neutrophil count > 1,500/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.

Who cannot join

  • 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 CTC criteria), 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 containing lycopene for at least 14 days prior to start of therapy
  • Evidence of Grade 2 neuropathy at time of screening.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Ralph H. Johnson Veterans Administration Medical Center

    Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: A Phase I Study of Docetaxel Plus Synthetic Lycopene in Metastatic Prostate Cancer Patients With Biochemical or Clinical Relapse

Docetaxel is the standard, first-line chemotherapeutic agent for castrate resistant prostate cancer. While it has clinically useful activity, there is a strong need for substantial improvement in its efficacy. Possible ways for improving docetaxel monotherapy would be to combine it with an agent that either minimized toxicity (thus allowing higher doses) or improves efficacy (by targeting synergistic pathways). Lycopene is an attractive agent for combination with docetaxel because of its known accumulation in prostate tissue, its low toxicity, and its ability to inhibit signaling through the IGF-1 axis, and to reduce IL6 levels. Lycopene is highly synergistic with docetaxel at inhibiting the growth of prostate cancer in mice. The purpose of this study is to determine the maximum tolerated dose (MTD) of lycopene given in combination with docetaxel. This dose can then be used for subsequent phase II or phase III studies.

New findings from the ECOG E3805 study presented at ASCO 2014, showed that concurrent chemotherapy with first-line ADT for newly diagnosed metastatic prostate cancer markedly improved overall survival compared with delayed or no chemotherapy. These subjects could also benefit from intervention to increase docetaxel effectiveness.

Being tested
Lycopene and Docetaxel
Keywords
prostate cancer, lycopene, docetaxel, metastatic, castration resistant
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lycopene and DocetaxelDrug

    Also called LycoVit, Taxotere

    During administration of standard of care Docetaxel at 75 mg/m2 on day 15 and every 21 days, study patients will also receive Lycopene at the dose specified per the dose cohort they are enrolled. There are three dose cohort levels as follows: Dose level 1 = 30 mg PO every day; Dose level 2 = 90 mg PO every day; Dose level 3 = 150 mg PO every day.Treatment will continue until disease progression or toxicity or patient withdrawal.

Study groups in NCT01949519
Study groupRoleWhat they receive
Docetaxel and LycopeneExperimentalNot described
Receives: Drug: Lycopene and Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determination of the Maximum Tolerated Dose of Lycopene when given in combination with docetaxel

    Measured: The Dose Limiting Toxicity period is from Day 1 to Day 36 of study treatment with Lycopene and Docetaxel

Secondary outcomes (3)

  1. IGF1 signaling inhibition at MTD

    To determine the ability of lycopene given at the MTD in combination with docetaxel, to inhibit IGF1 signaling, as reflected in the level of phosphoIGF1R (Y1131) following ex vivo stimulation of PBMNCs.

    Measured: For patients treated at the dose determined to be the MTD, IGF1 signaling inhibition will be studied at Day 1 and Day 64.

  2. Pharmacokinetic assessment of docetaxel and lycopene

    To determine the effects of lycopene on the pharmacokinetics of docetaxel and effects of docetaxel on the pharmacokinetics of lycopene during combination therapy.

    Measured: For patients treated at the dose determined to be the MTD, IGF1 signaling inhibition will be studied at Day 1 and Day 64.

  3. Assessment of plasma levels of IL6, IGF1, IGF-2, and IGFBP3; and IGF1R level

    To determine the effects of lycopene + docetaxel therapy on plasma levels of IL6, IGF1, IGF-2, and IGFBP3; and IGF1R level in peripheral blood mononuclear cells.

    Measured: Pre-tx and Days 15,36,57,78,and 99. (during MTD phase only): pre-tx, Days 22, 43,64.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionJun 2015
  4. Study completion12 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01949519
Sponsor's protocol ID
101681
Other IDs
1R21CA166839-01A1
Status last verified
Oct 2016
First submitted
16 Sep 2013
Last updated
11 Jan 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lycopene and Docetaxel in people with Adenocarcinoma of the Prostate, run by Medical University of South Carolina at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of the Maximum Tolerated Dose of Lycopene when given in combination with docetaxel (time frame: The Dose Limiting Toxicity period is from Day 1 to Day 36 of study treatment with Lycopene and Docetaxel). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01949519.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2018.

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