Multicenter Study Comparing Taxotere Plus Curcumin Versus Taxotere Plus Placebo Combination in First-line Treatment of Prostate Cancer Metastatic Castration Resistant (CURTAXEL)

NCT ID: NCT02095717

Last Updated: 2018-07-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2018-04-30

Brief Summary

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. Assess time to progression (time to progression) of metastatic disease (from first day of treatment in the trial).

Conditions

Prostate Cancer Metastatic Castration Resistant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Curcumin

curcumine capsule

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DRUG

Taxotere

Intervention Type: DRUG

Placebo

placebo capsule

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Taxotere

Intervention Type: DRUG

Interventions

Curcumin

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Taxotere

Intervention Type: DRUG

Eligibility Criteria

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: objective progression of at least one measurable tumor target and / or assessable by RECIST, 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Jean Perrin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique de la Chataigneraie

Beaumont, , France

Centre Jean Perrin

Clermont-Ferrand, , France

Centre Hospitalier Emile Roux

Le Puy-en-Velay, , France

Institut Jean Godinot

Reims, , France

Countries

France

Other Identifiers

2013-002138-20

Identifier Type: -

Identifier Source: org_study_id