- ICH GCP
- US Clinical Trials Registry
- 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) (CURTAXEL)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Beaumont, France
- Clinique De La Chataigneraie
-
Clermont-Ferrand, France
- Centre Jean Perrin
-
Le Puy en velay, France
- Centre Hospitalier Emile Roux
-
Reims, France
- Institut Jean Godinot
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Curcumin
curcumine capsule
|
|
Placebo Comparator: Placebo
placebo capsule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PSA response
Time Frame: 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)
|
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)
|
Evaluate the objective tumor response rate (CR + PR) by RECIST.
|
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
|
Assess the safety (adverse events) of the combination Taxotere/ curcumin.
|
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)
|
Assess pain in the short questionnaire on pain (QCD)
|
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
|
Assess serum neuroendocrine markers
|
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
|
Evaluate overall survival (between inclusion and death whatever the cause)
|
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
|
Evaluate the anti-angiogenic activity of the association Taxotere ® plus curcumin
|
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
|
Assess the compliance by curcumin treatment / placebo orally
|
patients will be followed for the duration of the treatment, an expected average of 4 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
- Curcumin
Other Study ID Numbers
- 2013-002138-20
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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