Overview

This trial is active, not recruiting.

Condition prostate cancer metastatic castration resistant
Treatments curcumin, placebo, taxotere
Phase phase 2
Sponsor Centre Jean Perrin
Start date March 2014
End date January 2017
Trial size 50 participants
Trial identifier NCT02095717, 2013-002138-20

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
curcumine capsule
curcumin
taxotere
(Placebo Comparator)
placebo capsule
placebo
taxotere

Primary Outcomes

Measure
Time to progression
time frame: 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
time frame: From date of randomization until the date of first documented PSA progression or date of death from any cause
objective tumor response rate
time frame: participants will be evaluated at the end of the treatment (randomization + an expected average of 4 months)
safety and tolerability
time frame: patients will be followed for the duration of the treatment, an expected average of 4 months
Pain
time frame: participants will be followed at Cycle1,3,6 of chemotherapy and post treatment (+1months after the end of the treatment)
neuroendocrine markers
time frame: participants will be followed for the duration of the treatment, an expected average of 4 months
Overall survival
time frame: from date of randomization until the date of death from any cause
anti-angiogenic activity
time frame: participants will be followed at each Cycle of chemotherapy ( + inclusion) , an expected average of 4 months
compliance
time frame: patients will be followed for the duration of the treatment, an expected average of 4 months

Eligibility Criteria

Male participants at least 18 years old.

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 information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Centre Jean Perrin.