Clinical trial NCT02095717: Multicenter Study Comparing Taxotere Plus Curcumin Versus Taxotere Plus Placebo Combination in First-line Treatment of Prostate Cancer Metastatic Castration Resistant (CURTAXEL)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer Metastatic Castration Resistant
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Time to progression
timeFrame: participants will be followed post treatment. From date of randomization until the date of first documented progression or date of death from any cause
Secondary outcomes:
measure: PSA response
timeFrame: From date of randomization until the date of first documented PSA progression or date of death from any cause
measure: objective tumor response rate
timeFrame: participants will be evaluated at the end of the treatment (randomization + an expected average of 4 months)
measure: safety and tolerability
timeFrame: patients will be followed for the duration of the treatment, an expected average of 4 months
measure: Pain
timeFrame: participants will be followed at Cycle1,3,6 of chemotherapy and post treatment (+1months after the end of the treatment)
measure: neuroendocrine markers
timeFrame: participants will be followed for the duration of the treatment, an expected average of 4 months
measure: Overall survival
timeFrame: from date of randomization until the date of death from any cause
measure: anti-angiogenic activity
timeFrame: participants will be followed at each Cycle of chemotherapy ( + inclusion) , an expected average of 4 months
measure: compliance
timeFrame: patients will be followed for the duration of the treatment, an expected average of 4 months
Other outcomes:
Locations:
city: Beaumont
country: France
facility: Clinique de la Chataigneraie
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Le Puy en velay
country: France
facility: Centre Hospitalier Emile Roux
city: Reims
country: France
facility: Institut Jean Godinot
Study officials:
References: