Treatment of Locally Advanced or Metastatic Transitional Cell Carcinoma With Cabazitaxel

NCT01668459 | Completed Phase 2 DMC

• 2 other identifiers: RRK43682012-002552-16
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A study for patients with confirmed locally advanced or metastatic Transitional Cell Carcinoma of the bladder or upper urinary tracts who have developed progressive disease within 12 months of their platinum based chemotherapy. The study aims to compare the overall response rate of cabazitaxel treatment versus best supportive care including single agent chemotherapy.

Conditions

Transitional Cell Carcinoma

Keywords

Transitional cell carcinoma; Bladder cancer; Cancer; Oncology; Cabazitaxel

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  To compare the overall response rate of patients administered cabazitaxel vs best supportive care (including single agent chemotherapy) in patients with transitional cell carcinoma who have previously progressed on a platinum-based regimen.

  Change from baseline at Week 9 and Week 18

Secondary Outcomes (3)

• Overall survival

  From date of randomisation to the date of tumour progression or death (from any cause) (or survival at study cut-off date), whichever came first up to 12months after the final patient has completed study treatment

• Quality of Life

  Change from baseline at Week 6, Week 12, Week 18, Week 21

• Safety and tolerability

  From date of randomisation up to 30 days after final dose of study medication

Study Arms (2)

Cabazitaxel

EXPERIMENTAL

6 cycles (3 weekly) of 25 mg/m\^2 IV infusion

Drug: Cabazitaxel

Best Supportive Care

OTHER

Best supportive care including single agent chemotherapy as determined by the patient's study doctor

Other: Best Supportive Care

Interventions

Cabazitaxel DRUG

25 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: maximum 6

Also known as: Jevtana, XRP6258, RPR116258A

Cabazitaxel

Best Supportive Care OTHER

Best Supportive Care including single agent chemotherapy as determined by the patient's study physician

Best Supportive Care

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
• Age ≥ 18
• Life expectancy ≥ 12 weeks
• Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) including mixed pathology with predominantly TCC, with locally advanced (T4b) or metastatic (lymph node or visceral) TCC arising from bladder or upper urinary tracts.
• Treated patients with incidental prostate cancer (pT2, Gleason ≤ 6) and PSA (Prostate Specific Antigen) ≤ 0.5 ng/mL are eligible
• Measurable disease as per RECIST Criteria 1.1
• ECOG Performance Status 0-1.
• Previously received first line platinum based treatment.
• Recurrence within 12 months (by RECIST criteria version 1.1) from last cycle of chemotherapy.

You may not qualify if:

• Previous therapy with a taxane.
• Pure non TCC histologies
• Grade II or more peripheral neuropathy
• Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrolment in the study.
• Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
• Inadequate organ and bone marrow function as evidenced by:
• Hemoglobin \< 9.0 g/dL
• Absolute neutrophil count \< 1.5 x 109/L,
• Platelet count \< 100 x 109/L,
• AST/SGOT and/or ALT/SGPT \> 2.5 x ULN;
• Total bilirubin \> 1.0 x ULN,
• Serum creatinine \> 1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance ≤ 30 mL/min should be excluded (see Appendix 6 for formula)
• Symptomatic brain metastases or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement).
• History of another neoplasm except non-metastatic melanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery, small field radiation or chemotherapy \< 5 years prior to randomization.
• History of inflammatory bowel disease, significant bowel obstruction.

Sponsors & Collaborators

• Dr Anjali Zarkar: lead
• Sanofi: collaborator

Study Sites (1)

University Hospitals Birmingham

Birmingham, B15 2TH, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Urinary Bladder Neoplasms; Neoplasms

Interventions

cabazitaxel; XRP6258

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Anjali Zarkar

  University Hospitals Birmingham NHS FT

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 13, 2012
• First Posted: August 20, 2012
• Study Start: January 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: December 4, 2018

Record last verified: 2018-11

Locations

GB (1)