Clinical trial · Interventional
Multicenter Study Comparing Taxotere Plus Curcumin Versus Taxotere Plus Placebo Combination in First-line Treatment of Prostate Cancer Metastatic Castration Resistant (CURTAXEL)
NCT02095717CI-TRIAL-00033947CURTAXELterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The trial was stopped for futility in view of the results of the interim analysis
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer Metastatic Castration Resistant | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Curcumin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Taxotere | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Curcumin
- description
- curcumine capsule
- interventionNames
- Drug: Curcumin
- Drug: Taxotere
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- placebo capsule
- interventionNames
- Drug: Placebo
- Drug: Taxotere
Primary outcomes (1)
- measure
- Time to progression
- timeFrame
- participants will be followed post treatment. From date of randomization until the date of first documented progression or date of death from any cause
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.References
Publications (0)
Data not yet available
No reference posted for this study.