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

NCT02095717 | Terminated Phase 2

• 1 other identifier: 2013-002138-20
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Time to progression

  Assess time to progression (time to progression) of metastatic disease (from first day of treatment in the trial). Progression was defined as an increase (of) injury (s) tumor (s) (RECIST) or an increase in PSA levels (≥ 25% and ≥ 2ng/ml increase) or the appearance of new lesions metastatic (at least 2 new lesions for bone lesions). From date of randomization until the date of first documented progression or date of death from any cause

  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 (8)

• PSA response

  From date of randomization until the date of first documented PSA progression or date of death from any cause

• objective tumor response rate

  participants will be evaluated at the end of the treatment (randomization + an expected average of 4 months)

• safety and tolerability

  patients will be followed for the duration of the treatment, an expected average of 4 months

• Pain

  participants will be followed at Cycle1,3,6 of chemotherapy and post treatment (+1months after the end of the treatment)

• neuroendocrine markers

  participants will be followed for the duration of the treatment, an expected average of 4 months

Study Arms (2)

Curcumin

EXPERIMENTAL

curcumine capsule

Drug: Curcumin; Drug: Taxotere

Placebo

PLACEBO COMPARATOR

placebo capsule

Drug: Placebo; Drug: Taxotere

Interventions

Curcumin DRUG

Curcumin

Placebo DRUG

Placebo

Taxotere DRUG

Curcumin; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Centre Jean Perrin: lead

Study Sites (4)

Clinique de la Chataigneraie

Beaumont, France

Location

Centre Jean Perrin

Clermont-Ferrand, France

Location

Centre Hospitalier Emile Roux

Le Puy-en-Velay, France

Location

Institut Jean Godinot

Reims, France

Location

MeSH Terms

Interventions

Curcumin; Docetaxel

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: March 26, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: July 24, 2018

Record last verified: 2018-07

Locations

FR (4)