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

Centre Jean Perrin

Status and phase

Completed

Phase 2

Conditions

Metastatic Prostate Cancer

Treatments

Dietary Supplement: phytochemical

Drug: Docetaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT01012141

AU 793

Details and patient eligibility

About

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.

Full description

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

Enrollment

30 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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