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

• Status: Unknown status
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Associació per a la Recerca Oncologica, Spain
• Treatments: Vinblastine

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