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

• Status: Terminated
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Jean Perrin
• Treatments: Curcumin; Docetaxel

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.