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

NCT01012141 | Completed Phase 2

• 1 other identifier: AU 793
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Response rate as assessed by clinical, biological and paraclinical examination

Secondary Outcomes (5)

• Safety as assessed by NCI CTCAE v3.0

• To assess the best neuroendocine markers between chromogranin A (CgA), neuron-specific enolase (NSE) and serotonin

• Time to progression as assessed by RECIST criteria and PSA level

• To assess compliance of per os phytonutrient treatment

• Geriatric assessment impact on compliance

Interventions

phytochemical DIETARY_SUPPLEMENT

Docetaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Jean Perrin: lead

Study Sites (2)

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Phytochemicals; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biological Factors; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Philippe Chollet, MD

  Centre Jean Perrin

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pr

Study Record Dates

• First Submitted: November 10, 2009
• First Posted: November 11, 2009
• Study Start: September 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 10, 2013

Record last verified: 2009-11

Locations

FR (2)