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

Phase 2
18 Years
Not Enrolling
Metastatic Prostate Cancer

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Trial Information

Pilot Phase II Study of Docetaxel in Combination With a Dietary Phytonutrient in First Line Treatment of Hormone Independent Metastatic 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

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate as assessed by clinical, biological and paraclinical examination

Safety Issue:


Principal Investigator

Philippe Chollet, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Jean Perrin


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

AU 793



Start Date:

September 2009

Completion Date:

April 2011

Related Keywords:

  • Metastatic Prostate Cancer
  • Prostatic Neoplasms