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