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

Centre Jean Perrin

Status and phase: Terminated; Phase 2

Conditions: Prostate Cancer Metastatic Castration Resistant

Treatments: Drug: Taxotere; Drug: Placebo; Drug: Curcumin

Study type: Interventional

Funder types: Other

Identifiers

NCT02095717

2013-002138-20

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Curcumin

Experimental group

Description:

curcumine capsule

Treatment:

Drug: Curcumin

Drug: Taxotere

Placebo

Placebo Comparator group

Description:

placebo capsule

Treatment:

Drug: Taxotere

Drug: Placebo