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Metastatic Prostate CancerPhase 2PROTAXYNCT01012141

Docetaxel With a Phytochemical in Treating Patients With Hormone Independent Metastatic Prostate Cancer

A Phase 2 study testing phytochemical and Docetaxel in people with Metastatic Prostate Cancer, run by Centre Jean Perrin at 2 sites in France.

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

RATIONALE : 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. Dietary supplements, such as phytochemicals, may stop or delay the development of prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Metastatic Prostate Cancer
What is being tested?
phytochemical and Docetaxel
How many people
30 participants
Where
2 sitesFrance
Study dates
Sep 2009to Apr 2011
Phase
Phase 2
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

  • Age >18
  • WHO performance status 0-2
  • Life expectancy ≥ 3 months
  • Patients receiving androgen-suppressive therapy in the form of chirurgical castration by orchiectomy or pulpectomy,or medical by LHRH agonist or antagonist with or without anti-androgen or all treatment blocking non gonadic testosterone fraction
  • Resulting to testosteronemia <0,5 ng/ml
  • Histologically confirmed adenocarcinomia of prostate cancer and documented hormone independant metastatic disease - defined by: objective progression with at least one measurable lesion and/or evaluable lesion according to RECIST criteria and /or a rise in PSA level ("rising PSA")
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  • Total bilirubin ≤ upper limit of normal (ULN).
  • AST and ALT ≤ 1.5 times ULN. Alkaline phosphatase ≤ 2.5 times ULN.
  • Serum creatinine < 140 µmol/L or creatinine clearance > 60 mL/ min.
  • Neutrophil count > 2.109 L-1.
  • Platelet count ≥ 100,000/mm3.
  • Hemoglobin ≥ 10 g/dL
  • Not previous chemotherapy, except Estracyt
  • No liver, kidney or heart failure link to treatment
  • No malabsorption syndrome or disease significantly affecting gastrointestinal function
  • Prior radiotherapies are permetted withing four weeks of the first study treatment and must be < 25 % of the bone marrow, and all adverse events must be resolved
  • Prior surgery are permitted.

Who cannot join

  • Age < 18
  • History of psychiatric disorders including psychotic disorder, dementia or seizures that would prohibit the understanding, observance and giving of informed consent
  • Previous or concomitant other malignancies except basal or squamous cell carcinoma of the skin or other cancer curatively treated with surgery and/or radiotherapy
  • Patients should not have symptomatic brain metastasis
  • Concurrent severe and/or uncontrolled co-morbid medical condition
  • Malabsorption syndrome or disease significantly affecting gastro-intestinal function or major resection of the stomach, proximal small bowel or grade > 2 dysphagia
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  • Patients with uncontrolled infection
  • History of significant neurologic (i.e. peripheral neuropathy grade > 2 using NCI-CTC criteria v3.0)
  • Patients should not have received NSAIDs or COX2 inhibitors within the three weeks prior to starting the study
  • Treatment with any investigational drug within 30 days prior to registration
  • Patients should not have current regimen containing dietary phytonutrients

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Institut Jean Godinot

    Reims, 51056

Other trials in France

About this study

Official title: Pilot Phase II Study of Docetaxel in Combination With a Dietary Phytonutrient in First Line Treatment of Hormone Independent Metastatic Prostate Cancer

RATIONALE : 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. Dietary supplements, such as phytochemicals, may stop or delay the development of prostate cancer.

Read the detailed description

The purpose of this study is to assess the pathological response rate in metastatic prostate cancer patients treated by : Docetaxel with a phytochemical

Being tested
phytochemical, Docetaxel
Medical subject headings
Prostatic Neoplasms

What participants receive

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

What is being measured

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

  1. Response rate as assessed by clinical, biological and paraclinical examination

Secondary outcomes (5)

  1. Safety as assessed by NCI CTCAE v3.0

  2. To assess the best neuroendocine markers between chromogranin A (CgA), neuron-specific enolase (NSE) and serotonin

  3. Time to progression as assessed by RECIST criteria and PSA level

  4. To assess compliance of per os phytonutrient treatment

  5. Geriatric assessment impact on compliance

Timeline

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

  1. First posted11 Nov 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionApr 2011
  4. Study completionApr 2011

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01012141
Sponsor's protocol ID
AU 793
Acronym
PROTAXY
Status last verified
Nov 2009
First submitted
10 Nov 2009
Last updated
10 Apr 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing phytochemical and Docetaxel in people with Metastatic Prostate Cancer, run by Centre Jean Perrin at 2 sites in France.

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 17 inclusion and 11 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 10 Apr 2013. 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 France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Response rate as assessed by clinical, biological and paraclinical examination. 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 NCT01012141.

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 10 Apr 2013.

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