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

Metastatic Prostate Cancer Clinical Trial

— PROTAXY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012141
• Other study ID #: AU 793
• Status: Completed
• Phase: Phase 2
• First received: November 10, 2009
• Last updated: April 9, 2013
• Start date: September 2009
• Est. completion date: April 2011

Study information

• Verified date: November 2009
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• phytochemical

Drug:
• Docetaxel

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont-Ferrand
France	Institut Jean Godinot	Reims

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate as assessed by clinical, biological and paraclinical examination			No
Secondary	Safety as assessed by NCI CTCAE v3.0			Yes
Secondary	To assess the best neuroendocine markers between chromogranin A (CgA), neuron-specific enolase (NSE) and serotonin			No
Secondary	Time to progression as assessed by RECIST criteria and PSA level			No
Secondary	To assess compliance of per os phytonutrient treatment			No
Secondary	Geriatric assessment impact on compliance			No