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

NCT01830231 | Unknown Phase 2 DMC

• 1 other identifier: Secavin-12
• Study Type: interventional
• Target: 372
• Locations: 2 countries
• Sites: 20

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.

Conditions

Urothelium Transitional Cell Carcinoma

Keywords

TCCU; Vinflunine; Cabazitaxel; Metastatic; Locally advance

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  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).

  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.

  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).

  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.

  From the date the informed consent is signed up to 30 days after the last dose.

Study Arms (2)

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

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.

Drug: Vinflunine

Interventions

Cabazitaxel DRUG

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

Also known as: Jevtana

Cabazitaxel

Vinflunine DRUG

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.

Also known as: Javlor

Vinflunine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Associació per a la Recerca Oncologica, Spain: lead

Study Sites (20)

NKI-AvL

Amsterdam, Amsterdam, Netherlands

RECRUITING

Vumc Amsterdam

Amsterdam, Amsterdam, Netherlands

NOT YET RECRUITING

St. Antoniusziekenhuis

Nieuwegein, Nieuwegein, Netherlands

RECRUITING

Erasmus MC Rotterdam

Rotterdam, Netherlands

RECRUITING

Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña, 15006, Spain

RECRUITING

Centro Oncologico de Galica

A Coruña, A Coruña, 15009, Spain

RECRUITING

Hospital Clínico Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

RECRUITING

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

RECRUITING

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

RECRUITING

Hospital Vall d´Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

Hospital San Pedro de Alcántara

Cáceres, Cáceres, 10003, Spain

RECRUITING

Hospital Ramón y Cajal

Madrid, Madrid, 28034, Spain

RECRUITING

Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, Madrid, Spain

NOT YET RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

NOT YET RECRUITING

Hospital Morales Meseguer

Murcia, Murcia, 30008, Spain

RECRUITING

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Complejo Hospitalario Universitario Ourense. Hospital Santa María Nai

Ourense, Ourense, 32005, Spain

RECRUITING

Hospital Son Llatzer

Palma de Mallorca, Palma de Mallorca, 07198, Spain

RECRUITING

Hospital Lzoano Blesa

Zaragoza, Zaragoza, 50009, Spain

RECRUITING

Related Publications (2)

• 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.

  PMID: 20231682 BACKGROUND

• 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.

  PMID: 28419193 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

cabazitaxel; vinflunine

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joaquim Bellmunt, MD/PhD

  APRO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joaquim Bellmunt, MD/PhD

CONTACT

+34 93 2483137; jbellmunt@parcdesalutmar.cat

Inmaculada Musté

CONTACT

+34 93 2483137; oncologia.apro@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 12, 2013
• Study Start: October 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 28, 2014

Record last verified: 2014-01

Locations

ES (16); NL (4)