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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

November 10, 2009
April 9, 2013
September 2009
April 2011   (final data collection date for primary outcome measure)
Response rate as assessed by clinical, biological and paraclinical examination [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01012141 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Docetaxel With a Phytochemical in Treating Patients With Hormone Independent Metastatic Prostate Cancer
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.

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

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Prostate Cancer
  • Dietary Supplement: phytochemical
  • Drug: Docetaxel
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01012141
AU 793
No
Philippe Chollet, Centre Jean Perrin
Centre Jean Perrin
Not Provided
Study Chair: Philippe Chollet, MD Centre Jean Perrin
Centre Jean Perrin
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP