NeoplasmsPhase 3TROPICNCT00417079
XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer
A Phase 3 study testing cabazitaxel (XRP6258) (RPR116258), mitoxantrone and prednisone in people with Neoplasms and Prostatic Neoplasms, run by Sanofi at 26 sites in 26 countries.
Trial summary
This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen. The primary objective is overall survival. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Neoplasms, Prostatic Neoplasms
- What is being tested?
- cabazitaxel (XRP6258) (RPR116258), mitoxantrone and prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 755 participants
- Where
- 26 sitesin 26 countries
- Study dates
- Jan 2007to Sep 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically or cytologically confirmed adenocarcinoma of the prostate that is refractory to hormone therapy and previously treated with a Taxotere®-containing regimen.
- Documented progression of disease (demonstrating at least one visceral or soft tissue metastatic lesion, including a new lesion). Patients with non-measurable disease must have documented rising prostate-specific antigen (PSA) levels or appearance of new lesion.
- Surgical or hormone-induced castration
- Life expectancy > 2 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
Who cannot join
- Previous treatment with mitoxantrone
- Previous treatment with <225 mg/m^2 cumulative dose of Taxotere (or docetaxel)
- Prior radiotherapy to ≥ 40% of bone marrow
- Surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment in the study
- Other prior malignancy, except for adequately treated superficial basal cell skin cancer, or any other cancer from which the patient has been disease-free for less than 5 years
- Known brain or leptomeningeal involvement
Show all 9Show fewer
- Other concurrent serious illness or medical conditions
- Inadequate organ function evidenced by unacceptable laboratory results
- The investigator will evaluate whether there are other reasons why a patient may not participate.
Trial locations and contacts
26 sites in 26 countries.
26 sites in 26 countries
About this study
Official title: A Randomized, Open Label Multi-Center Study of XRP6258 at 25 mg/m^2 in Combination With Prednisone Every 3 Weeks Compared to Mitoxantrone in Combination With Prednisone For The Treatment of Hormone Refractory Metastatic Prostate Cancer Previously Treated With A Taxotere®-Containing Regimen
This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen. The primary objective is overall survival. Secondary objectives include progression free survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain response/progression, overall safety, and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients will have long-term follow-up for a maximum of up to 2 years.
- Conditions
- Neoplasms, Prostatic Neoplasms
- Being tested
- cabazitaxel (XRP6258) (RPR116258), mitoxantrone, prednisone
- Keywords
- Cancer, Prostate
- Medical subject headings
- Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cabazitaxel (XRP6258) (RPR116258)Drug
Also called Jevtana
25 mg/m^2 administered by intravenous (IV) route over 1 hour on day 1 of each 21-day cycle
mitoxantroneDrug
12 mg/m^2 administered by intravenous (IV) route over 15-30 minutes on day 1 of each 21-day cycle
prednisoneDrug
10 mg daily administered by oral route
| Study group | Role | What they receive |
|---|---|---|
| Mitoxantrone + Prednisone | Active comparator | Mitoxantrone + Prednisone Receives: Drug: mitoxantrone; Drug: prednisone |
| Cabazitaxel + Prednisone | Experimental | Cabazitaxel + Prednisone Receives: Drug: cabazitaxel (XRP6258) (RPR116258); Drug: prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause.
In the absence of confirmation of death, the survival time was censored at the last date patient was known to be alive or at the cut-off date, whichever had come first.
Measured: From the date of randomization up to 104 weeks (study cut-off)
Secondary outcomes (7)
Time to Progression Free Survival (PFS)
Progression free survival was defined as a composite endpoint evaluated from the date of randomization to the date of tumor progression, PSA progression, pain progression, or death due to any cause, whichever occurred first
Measured: From the date of randomization up to 104 weeks (study cut-off)
Overall Tumor Response
Tumor Overall Response Rate (ORR) (only in patients with measurable disease):
Objective responses (Complete Response and Partial Response) for measurable disease as assessed by investigators according to RECIST criteria.
Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: At least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference baseline sum LD.
Confirmation of objective responses will be performed by repeat tumor imaging (CT scans, MRI, bone scans) after the first documentation of response.
Measured: From the date of randomization up to 104 weeks (study cut-off)
Time to Tumor Progression
Time to tumor progression is defined as the number of months from randomization until evidence of progressive disease (RECIST)
Measured: From the date of randomization up to 104 weeks (study cut-off)
Time to Prostatic Specific Antigen (PSA) Progression
In PSA non-responders, progression will be defined as a 25% increase over nadir and increase in the absolute value PSA level by at least 5 ng/ml and confirmed by a second value at least 4 weeks later.
In PSA responders and in patients not evaluable for PSA response at baseline, progression will be defined as a ≥50% increase over nadir, provided that the increase is a minimum of 5 ng/ml and confirmed by a second value at least 1 week later.
Measured: at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off)
PSA (Prostate-Specific Antigen) Response
PSA response was defined as a ≥ 50% reduction in serum PSA, determined only for patients with a serum PSA ≥ 20ng/mL at baseline, confirmed by a repeat PSA ≥ 3 weeks later.
Measured: from baseline up to 104 weeks (study cut-off)
Time to Pain Progression
Pain Progression is defined as an increase of ≥1 point in the median Personal Pain Intensity (PPI) from its nadir noted on 2 consecutive 3-week-apart visits or ≥25 % increase in the mean analgesic score compared with the baseline score \& noted on 2 consecutive 3-week-apart visits or requirement for local palliative radiotherapy.
Evaluation of the PPI \& analgesic scores are based on the short-form McGill Pain Questionnaire which consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0=none (best) 1=mild 2=moderate 3=severe (worst) (TOTAL: 0=best 45=worst)
Measured: from baseline up to 104 weeks (study cut-off)
Pain Response
Pain Response was defined as a two-point or greater reduction from baseline median Present Pain Intensity (PPI) score without an increased Analgesic Score (AS) or a decrease of ≥50% in the AS without an increase in the PPI score, maintained for at least 3 weeks.
Measured: from baseline up to 104 weeks (study cut-off)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2006 (estimated)
- Study startJan 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 755 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417079
- Sponsor's protocol ID
- EFC6193
- Acronym
- TROPIC
- Status last verified
- Mar 2011
- First submitted
- 28 Dec 2006
- Last updated
- 10 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Lorente D, Mateo J, Templeton AJ, Zafeiriou Z, Bianchini D, Ferraldeschi R, Bahl A, Shen L, Su Z, Sartor O, de Bono JS. Baseline neutrophil-lymphocyte ratio (NLR) is associated with survival and response to treatment with second-line chemotherapy for advanced prostate cancer independent of baseline steroid use. Ann Oncol. 2015 Apr;26(4):750-755. doi: 10.1093/annonc/mdu587. Epub 2014 Dec 23.
PubMed 25538172Bahl A, Oudard S, Tombal B, Ozguroglu M, Hansen S, Kocak I, Gravis G, Devin J, Shen L, de Bono JS, Sartor AO; TROPIC Investigators. Impact of cabazitaxel on 2-year survival and palliation of tumour-related pain in men with metastatic castration-resistant prostate cancer treated in the TROPIC trial. Ann Oncol. 2013 Sep;24(9):2402-8. doi: 10.1093/annonc/mdt194. Epub 2013 May 30.
PubMed 23723295Pouessel D, Oudard S, Gravis G, Priou F, Shen L, Culine S. [Cabazitaxel for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: the TROPIC study in France]. Bull Cancer. 2012 Jul-Aug;99(7-8):731-41. doi: 10.1684/bdc.2012.1608. French.
PubMed 22743148de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO; TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010 Oct 2;376(9747):1147-54. doi: 10.1016/S0140-6736(10)61389-X.
PubMed 20888992
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label Multi-Center Study of XRP6258 at 25 mg/m^2 in Combination With Prednisone Every 3 Weeks Compared to Mitoxantrone in Combination With Prednisone For The Treatment of Hormone Refractory Metastatic Prostate Cancer Previously Treated With A Taxotere®-Containing Regimen
- ClinicalTrials.gov ID
- NCT00417079
- Acronym / sponsor ID
- TROPIC / EFC6193
- Conditions
- Neoplasms, Prostatic Neoplasms
- Keywords
- Cancer, Prostate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 755 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 29 Dec 2006 (estimated)
- Results
- Posted 23 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen. The primary objective is overall survival. Secondary objectives include progression free survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain response/progression, overall safety, and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients will have long-term follow-up for a maximum of up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitoxantrone + Prednisone | Active comparator | Drug: mitoxantrone, Drug: prednisoneMitoxantrone + Prednisone |
| Cabazitaxel + Prednisone | Experimental | Drug: cabazitaxel (XRP6258) (RPR116258), Drug: prednisoneCabazitaxel + Prednisone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed adenocarcinoma of the prostate that is refractory to hormone therapy and previously treated with a Taxotere®-containing regimen.
- Documented progression of disease (demonstrating at least one visceral or soft tissue metastatic lesion, including a new lesion). Patients with non-measurable disease must have documented rising prostate-specific antigen (PSA) levels or appearance of new lesion.
- Surgical or hormone-induced castration
- Life expectancy > 2 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
Key exclusion criteria (9 listed)
- Previous treatment with mitoxantrone
- Previous treatment with <225 mg/m^2 cumulative dose of Taxotere (or docetaxel)
- Prior radiotherapy to ≥ 40% of bone marrow
- Surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment in the study
- Other prior malignancy, except for adequately treated superficial basal cell skin cancer, or any other cancer from which the patient has been disease-free for less than 5 years
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 |
|---|---|---|
| cabazitaxel (XRP6258) (RPR116258)Also: Jevtana25 mg/m^2 administered by intravenous (IV) route over 1 hour on day 1 of each 21-day cycle | Drug | Cabazitaxel + Prednisone |
| mitoxantrone12 mg/m^2 administered by intravenous (IV) route over 15-30 minutes on day 1 of each 21-day cycle | Drug | Mitoxantrone + Prednisone |
| prednisone10 mg daily administered by oral route | Drug | Cabazitaxel + Prednisone, Mitoxantrone + Prednisone |
Primary outcome
Overall Survival
Time frame: From the date of randomization up to 104 weeks (study cut-off)
Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, the survival time was censored at the last date patient was known to be alive or at the cut-off date, whichever had come first.
7 secondary outcomes
Time to Progression Free Survival (PFS)
Time frame: From the date of randomization up to 104 weeks (study cut-off)
Overall Tumor Response
Time frame: From the date of randomization up to 104 weeks (study cut-off)
Time to Tumor Progression
Time frame: From the date of randomization up to 104 weeks (study cut-off)
Time to Prostatic Specific Antigen (PSA) Progression
Time frame: at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off)
PSA (Prostate-Specific Antigen) Response
Time frame: from baseline up to 104 weeks (study cut-off)
Time to Pain Progression
Time frame: from baseline up to 104 weeks (study cut-off)
Pain Response
Time frame: from baseline up to 104 weeks (study cut-off)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25538172Lorente D, Mateo J, Templeton AJ, Zafeiriou Z, Bianchini D, Ferraldeschi R, Bahl A, Shen L, Su Z, Sartor O, de Bono JS. Baseline neutrophil-lymphocyte ratio (NLR) is associated with survival and response to treatment with second-line chemotherapy for advanced prostate cancer independent of baseline steroid use. Ann Oncol. 2015 Apr;26(4):750-755. doi: 10.1093/annonc/mdu587. Epub 2014 Dec 23.
- Derived from this study: PubMed 23723295Bahl A, Oudard S, Tombal B, Ozguroglu M, Hansen S, Kocak I, Gravis G, Devin J, Shen L, de Bono JS, Sartor AO; TROPIC Investigators. Impact of cabazitaxel on 2-year survival and palliation of tumour-related pain in men with metastatic castration-resistant prostate cancer treated in the TROPIC trial. Ann Oncol. 2013 Sep;24(9):2402-8. doi: 10.1093/annonc/mdt194. Epub 2013 May 30.
- Derived from this study: PubMed 22743148Pouessel D, Oudard S, Gravis G, Priou F, Shen L, Culine S. [Cabazitaxel for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: the TROPIC study in France]. Bull Cancer. 2012 Jul-Aug;99(7-8):731-41. doi: 10.1684/bdc.2012.1608. French.
- Derived from this study: PubMed 20888992de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO; TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010 Oct 2;376(9747):1147-54. doi: 10.1016/S0140-6736(10)61389-X.
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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.
ICD study director
Sanofi
26 sites in 26 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cabazitaxel (XRP6258) (RPR116258), mitoxantrone and prednisone in people with Neoplasms and Prostatic Neoplasms, run by Sanofi at 26 sites in 26 countries.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 10 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Argentina, Belgium, Brazil, Canada and 21 more countries. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival (time frame: From the date of randomization up to 104 weeks (study cut-off)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00417079, which also lists 4 linked publications.
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 10 Mar 2011.