Urothelium Transitional Cell CarcinomaPhase 2/3NCT01830231
Cabazitaxel vs. Vinflunine in Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium (TCCU)
A Phase 2/3 study testing Cabazitaxel and Vinflunine in people with Urothelium Transitional Cell Carcinoma, run by Associació per a la Recerca Oncologica, Spain at 20 sites in 2 countries.
Trial summary
Due to limited experience with cabazitaxel in TCCU, the study will be started as a randomised phase II study. The aim of the phase II study is to evaluate if the response rates (CR + PR) are sufficiently high to further study the treatment regimens in a phase III setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelium Transitional Cell Carcinoma
- What is being tested?
- Cabazitaxel and Vinflunine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Oct 2012to Nov 2016
- Phase
- Phase 2/3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Histologically confirmed TCCU (urinary bladder, urethra, ureter or renal pelvis). Patients with mixed histology may be enrolled if TCCU is the predominant component (i.e., > 50% of the histopathology sample) with the exception of neuroendocrine or small cell carcinoma.
- Advanced disease defined as a locally advanced tumour considered unresectable (T4b), node involvement in the inguinal area or above the aortic bifurcation (that are considered to be distant nodes and so metastasis) or metastasis in distant organs.
- Patient should have received one prior platinum-based chemotherapy treatment for locally advanced or stage IV TCCU. Prior platinum-based adjuvant or neoadjuvant therapy is allowed if more than 6 months have elapsed since the end of adjuvant or neoadjuvant therapy till tumour relapse.
- At least one measurable tumour lesion (measurable disease, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1
- ≥18 years.
Show all 14Show fewer
- ECOG PS 0 or 1.
- May have no more than ONE of the following unfavourable risk factors:
- haemoglobin <10 g/dL
- presence of liver metastasis
- ECOG PS 1
- Life expectancy of at least 12 weeks.
- Adequate hematologic, hepatic, and renal function, defined by:
- Females of childbearing potential must have a negative serum pregnancy test within 7 days of study entry.
Who cannot join
- Patients that have 2 or more of the following unfavourable risk factors:
- Haemoglobin <10 g/L
- Liver metastasis
- ECOG PS 1.
- Women who are currently pregnant or breast-feeding.
- Any unresolved non-hematologic Adverse Event (AE) grade >1 (Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) Version 4.0) from previous anti-cancer therapy (other than alopecia)
Show all 12Show fewer
- Patients who had undergone major surgery, radiation therapy or treatment with chemotherapy or any investigational agent within 28 days prior to Study day 1.
- Evidence of severe or uncontrolled systemic disease or any concurrent condition
- History of another neoplasm.
- History of hypersensitivity reactions to taxanes (docetaxel) (cabazitaxel specific criteria), vinca alkaloids (vinflunine specific criteria) or to any of the formulation excipients, including polysorbate 80
- clear evidence or symptoms of central nervous system metastasis (cabazitaxel specific criteria).
- Clinically significant cardiac condition
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
Spain16 sites, 16 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña, 15006
Luis Miguel Antón Aparicio, MD
- Recruiting
Centro Oncologico de Galica
A Coruña, A Coruña, 15009
Ana Medina, MD
- Recruiting
Hospital del Mar
Barcelona, Barcelona, 08003
Joaquim Bellmunt, MD/PhD
Joaquim Bellmunt, MD, PhD
- Recruiting
Hospital Vall d´Hebron
Barcelona, Barcelona, 08035
93 274 61 00
Rafael Morales, MD
- Recruiting
Hospital San Pedro de Alcántara
Cáceres, Cáceres, 10003
Ricardo Collado
- Recruiting
Hospital General Universitario de Elche
Elche, Alicante, 03203
Federico J. Vázquez
- Recruiting
Hospital Ramón y Cajal
Madrid, Madrid, 28034
Enrique Grande, MD
- Recruiting
Fundación Jiménez Díaz
Madrid, Madrid, 28040
Gustavo Rubio
- Not yet recruiting
Hospital Clínico San Carlos
Madrid, Madrid
José Luis González, MD
- Not yet recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid
Daniel Castellano, MD
- Recruiting
Hospital Morales Meseguer
Murcia, Murcia, 30008
Enrique González
- Recruiting
Complejo Hospitalario Universitario Ourense. Hospital Santa María Nai
Ourense, Ourense, 32005
Ovidio Fernández, MD
- Recruiting
Hospital Son Llatzer
Palma de Mallorca, Palma de Mallorca, 07198
Maria Belén González, MD
- Recruiting
Clínica Universidad de Navarra
Pamplona, Navarre, 31008
Jose L. Pérez
- Recruiting
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, 15706
Urbano Anido
- Recruiting
Hospital Lzoano Blesa
Zaragoza, Zaragoza, 50009
Eduardo Pujol, MD
Netherlands4 sites, 4 recruiting
- Recruiting
NKI-AvL
Amsterdam, Amsterdam
Martijn Kerst, MD
- Not yet recruiting
Vumc Amsterdam
Amsterdam, Amsterdam
van den Eertwegh, MD
- Recruiting
St. Antoniusziekenhuis
Nieuwegein, Nieuwegein
Maartje Los, MD
- Recruiting
Erasmus MC Rotterdam
Rotterdam
Ronald De witt, MD, PHD
About this study
Official title: A Randomised Phase II/III Study of Cabazitaxel Versus Vinflunine in Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium
Due to limited experience with cabazitaxel in TCCU, the study will be started as a randomised phase II study. The aim of the phase II study is to evaluate if the response rates (CR + PR) are sufficiently high to further study the treatment regimens in a phase III setting.
Read the detailed description
Once it is confirmed that the subjects fulfil the eligibility criteria and have signed the informed consent, they will be randomised to receive treatment based on cabazitaxel or vinflunine according to the following study schema:
(Randomize 1:1)
- Cabazitaxel 25 mg/m2 q3w
- Vinflunine 250-320 mg/m2 q3w
Random assignment of treatment will be stratified by the presence of 0 versus 1 of the following unfavourable prognostic risk factors proposed recently by Bellmunt et al. (1):
- Eastern Cooperative Oncology Group (ECOG) PS 1.
- Anaemia with Hb <10 g/dL.
- Presence of liver metastases.
All patients enrolled in the study will receive a cycle of treatment with the study medication (cabazitaxel or vinflunine) every 21 days until disease progression or intolerable/unacceptable toxicity. Tumour evaluations will be scheduled every 6 weeks until progression
- Conditions
- Urothelium Transitional Cell Carcinoma
- Being tested
- Cabazitaxel, Vinflunine
- Keywords
- TCCU, Vinflunine, Cabazitaxel, Metastatic, Locally advance
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabazitaxelDrug
Also called Jevtana
Cabazitaxel, to be given intravenously once every 21 days, starting at a dose of 25 mg/m2 as a 1-hour intravenous infusion.
VinflunineDrug
Also called Javlor
Vinflunine, to be given intravenously once every 21 days, as a 20 minute intravenous infusion, starting at a dose of:
- 320 mg/m2 in patients aged ≤75 years with PS 0 and no prior pelvic radiation, and of
- 280 mg/m2 in patients aged >75 - ≤80 years or with PS 1 or prior pelvic radiation,
- 250 mg/m2 in patients aged >80 years.
| Study group | Role | What they receive |
|---|---|---|
| Cabazitaxel | Experimental | Cabazitaxel 25 mg/m2 q3w. Cabazitaxel will be given intravenously once every 21 days, starting at a dose of 25 mg/m2 as a 1-hour intravenous infusion Receives: Drug: Cabazitaxel |
| Vinflunine | Active comparator | • Vinflunine will be given intravenously once every 21 days, starting at a dose of:
* 320 mg/m2 in patients aged ≤75 years with PS 0 and no prior pelvic radiation
* 280 mg/m2 in patients aged >75 - ≤80 years, and/or with PS 1 and/or prior pelvic radiation,
* 250 mg/m2 in patients aged >80 years. Receives: Drug: Vinflunine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II main objective: to assess the efficacy of cabazitaxel compared to vinflunine in terms of improved objective response rate (ORR) of subjects with metastatic or locally advanced previously treated TCCU.
Efficacy of cabazitaxel compared to vinflunine on terms of improved objective response rate (ORR)
Measured: From date of randomization to disease progression or until 18 months from enrolment.
Phase III main objective: To assess the efficacy of cabazitaxel compared to vinflunine in terms of improved overall survival (OS) of subjects with metastatic or locally advanced, previously treated TCCU.
Measured: From date of randomization to death from any cause or until 18 months from enrolment.
Secondary outcomes (4)
Phase II secondary objective: to assess the efficacy of cabazitaxel compared to vinflunine in terms of improved progression-free survival (PFS) and overall survival (OS).
Measured: From randomisation to either documented disease progression or death from any cause or until 18 months from enrolment (whichever occurs earlier)
Phase II secondary objective: safety profile and tolerability of cabazitaxel. It will be determined from the number of Adverse Events reported.
Measured: From the date the informed consent is signed up to 30 days after the last dose.
Phase III secondary objective: to assess the efficacy of cabazitaxel compared to vinflunine in terms of improved objetive response rate (ORR) and progression free survival (PFS).
Measured: From randomisation to either documented disease progression or death from any cause or until 18 months from enrolment (whichever occurs earlier)
Phase III secondary objective: safety profile and tolerability of cabazitaxel. It will be determined from the number of Adverse Events reported.
Measured: From the date the informed consent is signed up to 30 days after the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startOct 2012
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urothelium Transitional Cell CarcinomaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associació per a la Recerca Oncologica, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joaquim Bellmunt, MD/PhD, Principal investigator, APRO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830231
- Sponsor's protocol ID
- Secavin-12
- Status last verified
- Jan 2014
- First submitted
- 2 Apr 2013
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bellmunt J, Choueiri TK, Fougeray R, Schutz FA, Salhi Y, Winquist E, Culine S, von der Maase H, Vaughn DJ, Rosenberg JE. Prognostic factors in patients with advanced transitional cell carcinoma of the urothelial tract experiencing treatment failure with platinum-containing regimens. J Clin Oncol. 2010 Apr 10;28(11):1850-5. doi: 10.1200/JCO.2009.25.4599. Epub 2010 Mar 15.
PubMed 20231682Bellmunt J, Kerst JM, Vazquez F, Morales-Barrera R, Grande E, Medina A, Gonzalez Graguera MB, Rubio G, Anido U, Fernandez Calvo O, Gonzalez-Billalabeitia E, Van den Eertwegh AJM, Pujol E, Perez-Gracia JL, Gonzalez Larriba JL, Collado R, Los M, Macia S, De Wit R; SOGUG and DUOS. A randomized phase II/III study of cabazitaxel versus vinflunine in metastatic or locally advanced transitional cell carcinoma of the urothelium (SECAVIN). Ann Oncol. 2017 Jul 1;28(7):1517-1522. doi: 10.1093/annonc/mdx186.
PubMed 28419193
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Phase II/III Study of Cabazitaxel Versus Vinflunine in Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium
- ClinicalTrials.gov ID
- NCT01830231
- Acronym / sponsor ID
- Secavin-12
- Conditions
- Urothelium Transitional Cell Carcinoma
- Keywords
- TCCU, Vinflunine, Cabazitaxel, Metastatic, Locally advance
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- Associació per a la Recerca Oncologica, SpainUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 12 Apr 2013 (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.
Due to limited experience with cabazitaxel in TCCU, the study will be started as a randomised phase II study. The aim of the phase II study is to evaluate if the response rates (CR + PR) are sufficiently high to further study the treatment regimens in a phase III setting.
Detailed description
Once it is confirmed that the subjects fulfil the eligibility criteria and have signed the informed consent, they will be randomised to receive treatment based on cabazitaxel or vinflunine according to the following study schema:
(Randomize 1:1)
- Cabazitaxel 25 mg/m2 q3w
- Vinflunine 250-320 mg/m2 q3w
Random assignment of treatment will be stratified by the presence of 0 versus 1 of the following unfavourable prognostic risk factors proposed recently by Bellmunt et al. (1):
- Eastern Cooperative Oncology Group (ECOG) PS 1.
- Anaemia with Hb <10 g/dL.
- Presence of liver metastases.
All patients enrolled in the study will receive a cycle of treatment with the study medication (cabazitaxel or vinflunine) every 21 days until disease progression or intolerable/unacceptable toxicity. Tumour evaluations will be scheduled every 6 weeks until progression
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cabazitaxel | Experimental | Drug: CabazitaxelCabazitaxel 25 mg/m2 q3w. Cabazitaxel will be given intravenously once every 21 days, starting at a dose of 25 mg/m2 as a 1-hour intravenous infusion |
| Vinflunine | Active comparator | Drug: Vinflunine• Vinflunine will be given intravenously once every 21 days, starting at a dose of: * 320 mg/m2 in patients aged ≤75 years with PS 0 and no prior pelvic radiation * 280 mg/m2 in patients aged >75 - ≤80 years, and/or with PS 1 and/or prior pelvic radiation, * 250 mg/m2 in patients aged >80 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Written informed consent
- Histologically confirmed TCCU (urinary bladder, urethra, ureter or renal pelvis). Patients with mixed histology may be enrolled if TCCU is the predominant component (i.e., > 50% of the histopathology sample) with the exception of neuroendocrine or small cell carcinoma.
- Advanced disease defined as a locally advanced tumour considered unresectable (T4b), node involvement in the inguinal area or above the aortic bifurcation (that are considered to be distant nodes and so metastasis) or metastasis in distant organs.
- Patient should have received one prior platinum-based chemotherapy treatment for locally advanced or stage IV TCCU. Prior platinum-based adjuvant or neoadjuvant therapy is allowed if more than 6 months have elapsed since the end of adjuvant or neoadjuvant therapy till tumour relapse.
- At least one measurable tumour lesion (measurable disease, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1
Key exclusion criteria (12 listed)
- Patients that have 2 or more of the following unfavourable risk factors:
- Women who are currently pregnant or breast-feeding.
- Any unresolved non-hematologic Adverse Event (AE) grade >1 (Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) Version 4.0) from previous anti-cancer therapy (other than alopecia)
- Patients who had undergone major surgery, radiation therapy or treatment with chemotherapy or any investigational agent within 28 days prior to Study day 1.
- Evidence of severe or uncontrolled systemic disease or any concurrent condition
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 |
|---|---|---|
| CabazitaxelAlso: JevtanaCabazitaxel, to be given intravenously once every 21 days, starting at a dose of 25 mg/m2 as a 1-hour intravenous infusion. | Drug | Cabazitaxel |
| VinflunineAlso: JavlorVinflunine, to be given intravenously once every 21 days, as a 20 minute intravenous infusion, starting at a dose of: * 320 mg/m2 in patients aged ≤75 years with PS 0 and no prior pelvic radiation, and of * 280 mg/m2 in patients aged >75 - ≤80 years or with PS 1 or prior pelvic radiation, * 250 mg/m2 in patients aged >80 years. | Drug | Vinflunine |
Primary outcome
Phase II main objective: to assess the efficacy of cabazitaxel compared to vinflunine in terms of improved objective response rate (ORR) of subjects with metastatic or locally advanced previously treated TCCU.
Time frame: From date of randomization to disease progression or until 18 months from enrolment.
Efficacy of cabazitaxel compared to vinflunine on terms of improved objective response rate (ORR)
Phase III main objective: To assess the efficacy of cabazitaxel compared to vinflunine in terms of improved overall survival (OS) of subjects with metastatic or locally advanced, previously treated TCCU.
Time frame: From date of randomization to death from any cause or until 18 months from enrolment.
4 secondary outcomes
Phase II secondary objective: to assess the efficacy of cabazitaxel compared to vinflunine in terms of improved progression-free survival (PFS) and overall survival (OS).
Time frame: From randomisation to either documented disease progression or death from any cause or until 18 months from enrolment (whichever occurs earlier)
Phase II secondary objective: safety profile and tolerability of cabazitaxel. It will be determined from the number of Adverse Events reported.
Time frame: From the date the informed consent is signed up to 30 days after the last dose.
Phase III secondary objective: to assess the efficacy of cabazitaxel compared to vinflunine in terms of improved objetive response rate (ORR) and progression free survival (PFS).
Time frame: From randomisation to either documented disease progression or death from any cause or until 18 months from enrolment (whichever occurs earlier)
Phase III secondary objective: safety profile and tolerability of cabazitaxel. It will be determined from the number of Adverse Events reported.
Time frame: From the date the informed consent is signed up to 30 days after the last dose.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
- Background: PubMed 20231682Bellmunt J, Choueiri TK, Fougeray R, Schutz FA, Salhi Y, Winquist E, Culine S, von der Maase H, Vaughn DJ, Rosenberg JE. Prognostic factors in patients with advanced transitional cell carcinoma of the urothelial tract experiencing treatment failure with platinum-containing regimens. J Clin Oncol. 2010 Apr 10;28(11):1850-5. doi: 10.1200/JCO.2009.25.4599. Epub 2010 Mar 15.
- Derived from this study: PubMed 28419193Bellmunt J, Kerst JM, Vazquez F, Morales-Barrera R, Grande E, Medina A, Gonzalez Graguera MB, Rubio G, Anido U, Fernandez Calvo O, Gonzalez-Billalabeitia E, Van den Eertwegh AJM, Pujol E, Perez-Gracia JL, Gonzalez Larriba JL, Collado R, Los M, Macia S, De Wit R; SOGUG and DUOS. A randomized phase II/III study of cabazitaxel versus vinflunine in metastatic or locally advanced transitional cell carcinoma of the urothelium (SECAVIN). Ann Oncol. 2017 Jul 1;28(7):1517-1522. doi: 10.1093/annonc/mdx186.
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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.
Joaquim Bellmunt, MD/PhD principal investigator
APRO
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cabazitaxel and Vinflunine in people with Urothelium Transitional Cell Carcinoma, run by Associació per a la Recerca Oncologica, Spain at 20 sites in 2 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 14 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain, Netherlands. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joaquim Bellmunt, MD/PhD (+34 93 2483137, jbellmunt@parcdesalutmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase II main objective: to assess the efficacy of cabazitaxel compared to vinflunine in terms of improved objective response rate (ORR) of subjects with metastatic or locally advanced previously treated TCCU. (time frame: From date of randomization to disease progression or until 18 months from enrolment.). The study lists 2 primary outcomes in all. 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 NCT01830231, which also lists 2 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 28 Jan 2014.