Multicenter randomized phase II study, double-blind, comparing Taxotere plus curcumin versus Taxotere plus placebo combination in first-line treatment of prostate cancer metastatic castration resistant

Phase 1

• Conditions: metastatic prostate cancer; MedDRA version: 14.1Level: LLTClassification code 10066489Term: Progression of prostate cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-002138-20-FR
• Lead Sponsor: Centre Jean Perrin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-20
• Last Update Posted: 7 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

- Patient older than 18 years.
- Performance status = 2 according to the WHO criteria.
- Life expectancy> 3 months.
- Patient in hormonal blockade based on surgical castration by orchiectomy or pulpectomy, medical or agonist or antagonists of LHRH associated or not with anti-androgens or any other treatment that blocks the fraction of non-gonadal testosterone, resulting in a testosterone <0.5 ng / mL.
- Patient with adenocarcinoma of the prostate and histologically proven metastatic castration-resistant stage, defined by:
o objective progression of at least one measurable tumor target and / or assessable by RECIST,
o and / or increase in PSA (rising PSA).
- Satisfactory biological functions (renal, hepatic and hematologic)
- Patient who signed the consent for participation before entering the study.
- Affiliation to a social security scheme (or be the beneficiary of such a plan) under the terms of the law of 9 August 2004.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

- Age <18 years.
- Performance status> 2 according to the WHO criteria.
- Patient deprived of liberty or under guardianship, patient with (the) condition (s) psychological, family, social or geographic may interfere with the proper conduct of the study.
- Diagnosis of a second malignancy in the past 5 years, with the exception of a basal cell skin cancer considered cured.
- Patient with brain metastases at initial assessment.
- Patient with another pathology deemed incompatible with the inclusion in the protocol.
- Laboratory tests inadequate.
- History of malabsorption syndrome or extensive resection of the upper digestive tract.
- Uncontrolled intercurrent infection.
- Pathology autoimmune and / or chronic active inflammation.
- ? peripheral neuropathy grade 2 according to the criteria of the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 4.0).
- History of allergy to polysorbate 80.
- Treatment with nonsteroidal anti-inflammatory and / or cyclooxygenase-2 dated within three weeks.
- Concomitant with a drug test or participation in another clinical trial within <30 days treatment.
- Regular Taking dietary supplements.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified