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

Sponsor
Centre Jean Perrin (Other)
Overall Status
Terminated
CT.gov ID
NCT02095717
Collaborator
(none)
50
4
2
49
12.5
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Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Apr 1, 2018
Actual Study Completion Date :
Apr 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Curcumin

curcumine capsule

Drug: Curcumin

Drug: Taxotere

Placebo Comparator: Placebo

placebo capsule

Drug: Placebo

Drug: Taxotere

Outcome Measures

Primary Outcome Measures

  1. Time to progression [participants will be followed post treatment. From date of randomization until the date of first documented progression or date of death from any cause]

    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

Secondary Outcome Measures

  1. PSA response [From date of randomization until the date of first documented PSA progression or date of death from any cause]

    Evaluate the PSA response (50% decrease compared to the initial value)

  2. objective tumor response rate [participants will be evaluated at the end of the treatment (randomization + an expected average of 4 months)]

    Evaluate the objective tumor response rate (CR + PR) by RECIST.

  3. safety and tolerability [patients will be followed for the duration of the treatment, an expected average of 4 months]

    Assess the safety (adverse events) of the combination Taxotere/ curcumin.

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

    Assess pain in the short questionnaire on pain (QCD)

  5. neuroendocrine markers [participants will be followed for the duration of the treatment, an expected average of 4 months]

    Assess serum neuroendocrine markers

  6. Overall survival [from date of randomization until the date of death from any cause]

    Evaluate overall survival (between inclusion and death whatever the cause)

  7. anti-angiogenic activity [participants will be followed at each Cycle of chemotherapy ( + inclusion) , an expected average of 4 months]

    Evaluate the anti-angiogenic activity of the association Taxotere ® plus curcumin

  8. compliance [patients will be followed for the duration of the treatment, an expected average of 4 months]

    Assess the compliance by curcumin treatment / placebo orally

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinique de la Chataigneraie Beaumont France
2 Centre Jean Perrin Clermont-Ferrand France
3 Centre Hospitalier Emile Roux Le Puy en velay France
4 Institut Jean Godinot Reims France

Sponsors and Collaborators

  • Centre Jean Perrin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Jean Perrin
ClinicalTrials.gov Identifier:
NCT02095717
Other Study ID Numbers:
  • 2013-002138-20
First Posted:
Mar 26, 2014
Last Update Posted:
Jul 24, 2018
Last Verified:
Jul 1, 2018
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 24, 2018