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

Phase 2/Phase 3
18 Years
Open (Enrolling)
Urothelium Transitional Cell Carcinoma

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Trial Information

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

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

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

- Clinically significant cardiac condition

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Joaquim Bellmunt, MD/PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:



Spain: Spanish Agency of Medicines

Study ID:




Start Date:

October 2012

Completion Date:

November 2016

Related Keywords:

  • Urothelium Transitional Cell Carcinoma
  • TCCU
  • Vinflunine
  • Cabazitaxel
  • Metastatic
  • Locally advance
  • Carcinoma
  • Carcinoma, Transitional Cell