Prostate Cancer Metastatic Castration ResistantPhase 2CURTAXELNCT02095717
Multicenter Study Comparing Taxotere Plus Curcumin Versus Taxotere Plus Placebo Combination in First-line Treatment of Prostate Cancer Metastatic Castration Resistant (CURTAXEL)
A Phase 2 study testing Curcumin and Taxotere in people with Prostate Cancer Metastatic Castration Resistant, run by Centre Jean Perrin at 4 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic Castration Resistant
- What is being tested?
- Curcumin and Taxotere
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 4 sitesFrance
- Study dates
- Mar 2014to Apr 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Clinique de la Chataigneraie
Beaumont
Centre Jean Perrin
Clermont-Ferrand
Centre Hospitalier Emile Roux
Le Puy-en-Velay
Institut Jean Godinot
Reims
About this study
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).
- Being tested
- Curcumin, Placebo, Taxotere
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
PlaceboDrug
TaxotereDrug
| Study group | Role | What they receive |
|---|---|---|
| Curcumin | Experimental | curcumine capsule Receives: Drug: Curcumin; Drug: Taxotere |
| Placebo | Placebo comparator | placebo capsule Receives: Drug: Placebo; Drug: Taxotere |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Evaluate the PSA response (50% decrease compared to the initial value)
Measured: From date of randomization until the date of first documented PSA progression or date of death from any cause
objective tumor response rate
Evaluate the objective tumor response rate (CR + PR) by RECIST.
Measured: participants will be evaluated at the end of the treatment (randomization + an expected average of 4 months)
safety and tolerability
Assess the safety (adverse events) of the combination Taxotere/ curcumin.
Measured: patients will be followed for the duration of the treatment, an expected average of 4 months
Pain
Assess pain in the short questionnaire on pain (QCD)
Measured: participants will be followed at Cycle1,3,6 of chemotherapy and post treatment (+1months after the end of the treatment)
neuroendocrine markers
Assess serum neuroendocrine markers
Measured: participants will be followed for the duration of the treatment, an expected average of 4 months
Overall survival
Evaluate overall survival (between inclusion and death whatever the cause)
Measured: from date of randomization until the date of death from any cause
anti-angiogenic activity
Evaluate the anti-angiogenic activity of the association Taxotere ® plus curcumin
Measured: participants will be followed at each Cycle of chemotherapy ( + inclusion) , an expected average of 4 months
compliance
Assess the compliance by curcumin treatment / placebo orally
Measured: patients will be followed for the duration of the treatment, an expected average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2018
- Study completionApr 2018
Why it stopped: The trial was stopped for futility in view of the results of the interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Metastatic Castration ResistantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095717
- Sponsor's protocol ID
- 2013-002138-20
- Acronym
- CURTAXEL
- Status last verified
- Jul 2018
- First submitted
- 20 Mar 2014
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study Comparing Taxotere Plus Curcumin Versus Taxotere Plus Placebo Combination in First-line Treatment of Prostate Cancer Metastatic Castration Resistant (CURTAXEL)
- ClinicalTrials.gov ID
- NCT02095717
- Acronym / sponsor ID
- CURTAXEL / 2013-002138-20
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was stopped for futility in view of the results of the interim analysis
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curcumin | Experimental | Drug: Curcumin, Drug: Taxoterecurcumine capsule |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Taxotereplacebo capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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").
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin | Drug | Curcumin |
| Placebo | Drug | Placebo |
| Taxotere | Drug | Curcumin, Placebo |
Primary outcome
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
8 secondary outcomes
PSA response
Time frame: 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)
safety and tolerability
Time frame: 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)
neuroendocrine markers
Time frame: 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
anti-angiogenic activity
Time frame: 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
Results and safety
The study was stopped early (reason given: The trial was stopped for futility in view of the results of the interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
Related trials for Prostate Cancer Metastatic Castration Resistant
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Active, not recruitingPhase 2
Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Curcumin and Taxotere in people with Prostate Cancer Metastatic Castration Resistant, run by Centre Jean Perrin at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The trial was stopped for futility in view of the results of the interim analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.