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

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ClinicalTrials.gov Identifier: NCT01830231
Recruitment Status : Unknown
Verified January 2014 by Associació per a la Recerca Oncologica, Spain.
Recruitment status was:  Recruiting
First Posted : April 12, 2013
Last Update Posted : January 28, 2014
Sponsor:
Information provided by (Responsible Party):
Associació per a la Recerca Oncologica, Spain

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.

Condition or disease Intervention/treatment Phase
Urothelium Transitional Cell Carcinoma Drug: Cabazitaxel Drug: Vinflunine Phase 2 Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 372 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Phase II/III Study of Cabazitaxel Versus Vinflunine in Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium
Study Start Date : October 2012
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Cabazitaxel

Arm Intervention/treatment
Experimental: Cabazitaxel
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
Cabazitaxel, to be given intravenously once every 21 days, starting at a dose of 25 mg/m2 as a 1-hour intravenous infusion.
Other Name: Jevtana

Active Comparator: 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.
Drug: Vinflunine

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.
Other Name: Javlor




Primary Outcome Measures :
  1. 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)

  2. 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. ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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. ]
  3. 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) ]
  4. 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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830231


Contacts
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Contact: Joaquim Bellmunt, MD/PhD +34 93 2483137 jbellmunt@parcdesalutmar.cat
Contact: Inmaculada Musté +34 93 2483137 oncologia.apro@gmail.com

Locations
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Netherlands
NKI-AvL Recruiting
Amsterdam, Netherlands
Principal Investigator: Martijn Kerst, MD         
Vumc Amsterdam Not yet recruiting
Amsterdam, Netherlands
Principal Investigator: van den Eertwegh, MD         
St. Antoniusziekenhuis Recruiting
Nieuwegein, Netherlands
Principal Investigator: Maartje Los, MD         
Erasmus MC Rotterdam Recruiting
Rotterdam, Netherlands
Principal Investigator: Ronald De witt, MD, PHD         
Spain
Hospital Clínico Universitario de Santiago Recruiting
Santiago de Compostela, A Coruña, Spain, 15706
Principal Investigator: Urbano Anido         
Hospital General Universitario de Elche Recruiting
Elche, Alicante, Spain, 03203
Principal Investigator: Federico J. Vázquez         
Clínica Universidad de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Principal Investigator: Jose L. Pérez         
Complejo Hospitalario Universitario A Coruña Recruiting
A Coruña, Spain, 15006
Principal Investigator: Luis Miguel Antón Aparicio, MD         
Centro Oncologico de Galica Recruiting
A Coruña, Spain, 15009
Principal Investigator: Ana Medina, MD         
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: Joaquim Bellmunt, MD/PhD         
Principal Investigator: Joaquim Bellmunt, MD, PhD         
Hospital Vall d´Hebron Recruiting
Barcelona, Spain, 08035
Contact    93 274 61 00      
Principal Investigator: Rafael Morales, MD         
Hospital San Pedro de Alcántara Recruiting
Cáceres, Spain, 10003
Principal Investigator: Ricardo Collado         
Hospital Ramón y Cajal Recruiting
Madrid, Spain, 28034
Principal Investigator: Enrique Grande, MD         
Fundación Jiménez Díaz Recruiting
Madrid, Spain, 28040
Principal Investigator: Gustavo Rubio         
Hospital Clínico San Carlos Not yet recruiting
Madrid, Spain
Principal Investigator: José Luis González, MD         
Hospital Universitario 12 de Octubre Not yet recruiting
Madrid, Spain
Principal Investigator: Daniel Castellano, MD         
Hospital Morales Meseguer Recruiting
Murcia, Spain, 30008
Principal Investigator: Enrique González         
Complejo Hospitalario Universitario Ourense. Hospital Santa María Nai Recruiting
Ourense, Spain, 32005
Principal Investigator: Ovidio Fernández, MD         
Hospital Son Llatzer Recruiting
Palma de Mallorca, Spain, 07198
Principal Investigator: Maria Belén González, MD         
Hospital Lzoano Blesa Recruiting
Zaragoza, Spain, 50009
Principal Investigator: Eduardo Pujol, MD         
Sponsors and Collaborators
Associació per a la Recerca Oncologica, Spain
Investigators
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Principal Investigator: Joaquim Bellmunt, MD/PhD APRO

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Associació per a la Recerca Oncologica, Spain
ClinicalTrials.gov Identifier: NCT01830231     History of Changes
Other Study ID Numbers: Secavin-12
First Posted: April 12, 2013    Key Record Dates
Last Update Posted: January 28, 2014
Last Verified: January 2014
Keywords provided by Associació per a la Recerca Oncologica, Spain:
TCCU
Vinflunine
Cabazitaxel
Metastatic
Locally advance
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Vinblastine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action