Docetaxel With a Phytochemical in Treating Patients With Hormone Independent Metastatic Prostate Cancer (PROTAXY)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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 or disease
Metastatic Prostate Cancer
Dietary Supplement: phytochemicalDrug: Docetaxel
The purpose of this study is to assess the pathological response rate in metastatic prostate cancer patients treated by : Docetaxel with a phytochemical
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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