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Cabazitaxel vs. Vinflunine in Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium (TCCU)

Primary Purpose

Urothelium Transitional Cell Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Cabazitaxel

Vinflunine

About this trial

This is an interventional treatment trial for Urothelium Transitional Cell Carcinoma focused on measuring TCCU, Vinflunine, Cabazitaxel, Metastatic, Locally advance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
ECOG PS 0 or 1.
May have no more than ONE of the following unfavourable risk factors:
1. haemoglobin <10 g/dL
2. presence of liver metastasis
3. 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.

Exclusion Criteria:

Patients that have 2 or more of the following unfavourable risk factors:
1. Haemoglobin <10 g/L
2. Liver metastasis
3. 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)
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

Sites / Locations

NKI-AvLRecruiting
Vumc Amsterdam
St. AntoniusziekenhuisRecruiting
Erasmus MC RotterdamRecruiting
Hospital Clínico Universitario de SantiagoRecruiting
Hospital General Universitario de ElcheRecruiting
Clínica Universidad de NavarraRecruiting
Complejo Hospitalario Universitario A CoruñaRecruiting
Centro Oncologico de GalicaRecruiting
Hospital del MarRecruiting
Hospital Vall d´HebronRecruiting
Hospital San Pedro de AlcántaraRecruiting
Hospital Ramón y CajalRecruiting
Fundación Jiménez DíazRecruiting
Hospital Clínico San Carlos
Hospital Universitario 12 de Octubre
Hospital Morales MeseguerRecruiting
Complejo Hospitalario Universitario Ourense. Hospital Santa María NaiRecruiting
Hospital Son LlatzerRecruiting
Hospital Lzoano BlesaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cabazitaxel

Vinflunine

Arm Description

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

• 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.

Outcomes

Primary Outcome Measures

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)

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.

Secondary Outcome Measures

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).

Phase II secondary objective: safety profile and tolerability of cabazitaxel. It will be determined from the number of Adverse Events reported.

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).

Phase III secondary objective: safety profile and tolerability of cabazitaxel. It will be determined from the number of Adverse Events reported.

Full Information

NCT ID

NCT01830231

First Posted

April 2, 2013

Last Updated

January 27, 2014

Sponsor

Associació per a la Recerca Oncologica, Spain

1. Study Identification

Unique Protocol Identification Number

NCT01830231

Brief Title

Cabazitaxel vs. Vinflunine in Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium (TCCU)

Official Title

A Randomised Phase II/III Study of Cabazitaxel Versus Vinflunine in Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Unknown status

Study Start Date

October 2012 (undefined)

Primary Completion Date

November 2016 (Anticipated)

Study Completion Date

November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Associació per a la Recerca Oncologica, Spain

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urothelium Transitional Cell Carcinoma

Keywords

TCCU, Vinflunine, Cabazitaxel, Metastatic, Locally advance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

372 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cabazitaxel

Arm Type

Experimental

Arm Description

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

Arm Title

Vinflunine

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Cabazitaxel

Other Intervention Name(s)

Jevtana

Intervention Description

Cabazitaxel, to be given intravenously once every 21 days, starting at a dose of 25 mg/m2 as a 1-hour intravenous infusion.

Intervention Type

Drug

Intervention Name(s)

Vinflunine

Other Intervention Name(s)

Javlor

Intervention Description

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.

Primary Outcome Measure Information:

Title

Description

Efficacy of cabazitaxel compared to vinflunine on terms of improved objective response rate (ORR)

Time Frame

From date of randomization to disease progression or until 18 months from enrolment.

Title

Time Frame

From date of randomization to death from any cause or until 18 months from enrolment.

Secondary Outcome Measure Information:

Title

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)

Title

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.

Title

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)

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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. Exclusion Criteria: 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) 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joaquim Bellmunt, MD/PhD

Phone

+34 93 2483137

jbellmunt@parcdesalutmar.cat

First Name & Middle Initial & Last Name or Official Title & Degree

Inmaculada Musté

Phone

+34 93 2483137

oncologia.apro@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joaquim Bellmunt, MD/PhD

Organizational Affiliation

APRO

Official's Role

Principal Investigator

Facility Information:

Facility Name

NKI-AvL

City

Amsterdam

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martijn Kerst, MD

Facility Name

Vumc Amsterdam

City

Amsterdam

Country

Netherlands

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

van den Eertwegh, MD

Facility Name

St. Antoniusziekenhuis

City

Nieuwegein

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maartje Los, MD

Facility Name

Erasmus MC Rotterdam

City

Rotterdam

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ronald De witt, MD, PHD

Facility Name

Hospital Clínico Universitario de Santiago

City

Santiago de Compostela

State/Province

A Coruña

ZIP/Postal Code

15706

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Urbano Anido

Facility Name

Hospital General Universitario de Elche

City

Elche

State/Province

Alicante

ZIP/Postal Code

03203

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Federico J. Vázquez

Facility Name

Clínica Universidad de Navarra

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jose L. Pérez

Facility Name

Complejo Hospitalario Universitario A Coruña

City

A Coruña

ZIP/Postal Code

15006

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luis Miguel Antón Aparicio, MD

Facility Name

Centro Oncologico de Galica

City

A Coruña

ZIP/Postal Code

15009

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ana Medina, MD

Facility Name

Hospital del Mar

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joaquim Bellmunt, MD/PhD

First Name & Middle Initial & Last Name & Degree

Joaquim Bellmunt, MD, PhD

Facility Name

Hospital Vall d´Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

Phone

93 274 61 00

First Name & Middle Initial & Last Name & Degree

Rafael Morales, MD

Facility Name

Hospital San Pedro de Alcántara

City

Cáceres

ZIP/Postal Code

10003

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ricardo Collado

Facility Name

Hospital Ramón y Cajal

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Enrique Grande, MD

Facility Name

Fundación Jiménez Díaz

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gustavo Rubio

Facility Name

Hospital Clínico San Carlos

City

Madrid

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

José Luis González, MD

Facility Name

Hospital Universitario 12 de Octubre

City

Madrid

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel Castellano, MD

Facility Name

Hospital Morales Meseguer

City

Murcia

ZIP/Postal Code

30008

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Enrique González

Facility Name

Complejo Hospitalario Universitario Ourense. Hospital Santa María Nai

City

Ourense

ZIP/Postal Code

32005

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ovidio Fernández, MD

Facility Name

Hospital Son Llatzer

City

Palma de Mallorca

ZIP/Postal Code

07198

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Belén González, MD

Facility Name

Hospital Lzoano Blesa

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eduardo Pujol, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

20231682

Citation

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.

Results Reference

background

PubMed Identifier

28419193

Citation

Bellmunt 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.

Results Reference

derived

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Cabazitaxel vs. Vinflunine in Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium (TCCU)

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