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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philippe Chollet, Centre Jean Perrin
ClinicalTrials.gov Identifier:
NCT01012141
First received: November 10, 2009
Last updated: April 9, 2013
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Metastatic Prostate Cancer
 Dietary Supplement: phytochemical
Drug: Docetaxel
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Phase II Study of Docetaxel in Combination With a Dietary Phytonutrient in First Line Treatment of Hormone Independent Metastatic Prostate Cancer

Resource links provided by NLM:

Drug Information available for: Docetaxel
U.S. FDA Resources

Further study details as provided by Centre Jean Perrin:

Primary Outcome Measures:
  • Response rate as assessed by clinical, biological and paraclinical examination [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • To assess the best neuroendocine markers between chromogranin A (CgA), neuron-specific enolase (NSE) and serotonin [ Designated as safety issue: No ]
  • Time to progression as assessed by RECIST criteria and PSA level [ Designated as safety issue: No ]
  • To assess compliance of per os phytonutrient treatment [ Designated as safety issue: No ]
  • Geriatric assessment impact on compliance [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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")
  • 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.

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012141

Locations
France
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Institut Jean Godinot
Reims, France, 51056
Sponsors and Collaborators
Centre Jean Perrin
Investigators
Study Chair: Philippe Chollet, MD Centre Jean Perrin
  More Information

No publications provided

Responsible Party: Philippe Chollet, Pr, Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT01012141     History of Changes
Other Study ID Numbers: AU 793
Study First Received: November 10, 2009
Last Updated: April 9, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
 Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013