Back to resultsMulticenter Study Comparing Taxotere Plus Curcumin Versus Taxotere Plus Placebo Combination in First-line Treatment of Prostate Cancer Metastatic Castration Resistant (CURTAXEL) (CURTAXEL)
Primary Purpose
Prostate Cancer Metastatic Castration Resistant
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Curcumin
Placebo
Taxotere
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer Metastatic Castration Resistant
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.
Sites / Locations
- Clinique de la Chataigneraie
- Centre Jean Perrin
- Centre Hospitalier Emile Roux
- Institut Jean Godinot
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Curcumin
Placebo
Arm Description
curcumine capsule
placebo capsule
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
PSA response
Evaluate the PSA response (50% decrease compared to the initial value)
objective tumor response rate
Evaluate the objective tumor response rate (CR + PR) by RECIST.
safety and tolerability
Assess the safety (adverse events) of the combination Taxotere/ curcumin.
Pain
Assess pain in the short questionnaire on pain (QCD)
neuroendocrine markers
Assess serum neuroendocrine markers
Overall survival
Evaluate overall survival (between inclusion and death whatever the cause)
anti-angiogenic activity
Evaluate the anti-angiogenic activity of the association Taxotere ® plus curcumin
compliance
Assess the compliance by curcumin treatment / placebo orally
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02095717
Brief Title
Multicenter Study Comparing Taxotere Plus Curcumin Versus Taxotere Plus Placebo Combination in First-line Treatment of Prostate Cancer Metastatic Castration Resistant (CURTAXEL)
Acronym
CURTAXEL
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
The trial was stopped for futility in view of the results of the interim analysis
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Jean Perrin
4. Oversight
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Metastatic Castration Resistant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Curcumin
Arm Type
Experimental
Arm Description
curcumine capsule
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo capsule
Intervention Type
Drug
Intervention Name(s)
Curcumin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Taxotere
Primary Outcome Measure Information:
Title
Time to progression
Description
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
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 Outcome Measure Information:
Title
PSA response
Description
Evaluate the PSA response (50% decrease compared to the initial value)
Time Frame
From date of randomization until the date of first documented PSA progression or date of death from any cause
Title
objective tumor response rate
Description
Evaluate the objective tumor response rate (CR + PR) by RECIST.
Time Frame
participants will be evaluated at the end of the treatment (randomization + an expected average of 4 months)
Title
safety and tolerability
Description
Assess the safety (adverse events) of the combination Taxotere/ curcumin.
Time Frame
patients will be followed for the duration of the treatment, an expected average of 4 months
Title
Pain
Description
Assess pain in the short questionnaire on pain (QCD)
Time Frame
participants will be followed at Cycle1,3,6 of chemotherapy and post treatment (+1months after the end of the treatment)
Title
neuroendocrine markers
Description
Assess serum neuroendocrine markers
Time Frame
participants will be followed for the duration of the treatment, an expected average of 4 months
Title
Overall survival
Description
Evaluate overall survival (between inclusion and death whatever the cause)
Time Frame
from date of randomization until the date of death from any cause
Title
anti-angiogenic activity
Description
Evaluate the anti-angiogenic activity of the association Taxotere ® plus curcumin
Time Frame
participants will be followed at each Cycle of chemotherapy ( + inclusion) , an expected average of 4 months
Title
compliance
Description
Assess the compliance by curcumin treatment / placebo orally
Time Frame
patients will be followed for the duration of the treatment, an expected average of 4 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Clinique de la Chataigneraie
City
Beaumont
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
Country
France
Facility Name
Centre Hospitalier Emile Roux
City
Le Puy en velay
Country
France
Facility Name
Institut Jean Godinot
City
Reims
Country
France
12. IPD Sharing Statement
Learn more about this trial
Multicenter Study Comparing Taxotere Plus Curcumin Versus Taxotere Plus Placebo Combination in First-line Treatment of Prostate Cancer Metastatic Castration Resistant (CURTAXEL)
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