Status:
UNKNOWN
Cabazitaxel vs. Vinflunine in Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium (TCCU)
Lead Sponsor:
Associació per a la Recerca Oncologica, Spain
Conditions:
Urothelium Transitional Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 sufficien...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2016
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT01830231
Start Date
October 1 2012
End Date
November 1 2016
Last Update
January 28 2014
Active Locations (20)
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1
NKI-AvL
Amsterdam, Amsterdam, Netherlands
2
Vumc Amsterdam
Amsterdam, Amsterdam, Netherlands
3
St. Antoniusziekenhuis
Nieuwegein, Nieuwegein, Netherlands
4
Erasmus MC Rotterdam
Rotterdam, Netherlands