Bristol Bladder Trial

This study is currently recruiting participants.
Verified May 2012 by United Bristol Healthcare NHS Trust
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
United Bristol Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT01616875
First received: May 17, 2012
Last updated: June 8, 2012
Last verified: May 2012
  Purpose

26 patients with invasive primary transitional cell carcinoma of the bladder will receive 4 cycles of combination chemotherapy consisting of Cabazitaxel and Cisplatin both given intravenously on day 1 of each 3 weekly cycle prior to radical cystectomy, to evaluate the overall response rate and to determine whether this approach warrants further research of a phase II/III study.Participation in 2 sub studies will also be offered to the participants.

  1. Contrast Magnetic resonance imaging (MRI ) scans will be taken at baseline and after cycle 1 and cycle 3.
  2. A pilot sub study involving the circulating tumour cell concentration from blood samples taken at baseline, prior to each cycle of chemotherapy and prior to surgery

Condition Intervention Phase
Infiltrating Bladder Urothelial Carcinoma
Drug: Cabazitaxel + Cisplatin chemotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Combination Cabazitaxel and Cisplatin Chemotherapy in the Neo-adjuvant Treatment of Transitional Cell Carcinoma of the Urinary Bladder

Resource links provided by NLM:


Further study details as provided by United Bristol Healthcare NHS Trust:

Primary Outcome Measures:
  • Overall pathological response rate [ Time Frame: Histological assessment of radical cystectomy specimen expected to be 15 weeks after commencing study chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To record progression free survival [ Time Frame: Up to 5 years following radical cystectomy ] [ Designated as safety issue: No ]
    From date of registration until the date of first documented progression or date of death from any cause whichever came first.

  • To assess quality of life [ Time Frame: Up to 13 weeks from baseline ] [ Designated as safety issue: No ]
    EQ-5D and EORTC QLQC30 and BLM30 will be assessed at baseline and following each cycle of chemotherapy

  • To record side effects and tolerability of treatment [ Time Frame: Up to 13 weeks from baseline ] [ Designated as safety issue: Yes ]
    Common toxicity criteria adverse events (CTC AE ) Version 4.03 will be assessed at baseline and following each cycle of chemotherapy

  • Overall survival [ Time Frame: Up to 5 years following radical cystectomy ] [ Designated as safety issue: No ]
    From the date of registration to the date of death from any cause.


Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cabazitaxel + Cisplatin chemotherapy
Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles
Drug: Cabazitaxel + Cisplatin chemotherapy
Cabazitaxel 15mg/m2 followed by cisplatin 70mg/m2 given intravenously on day 1 of each 3 weekly cycle for 4 cycles prior to radical cystectomy.
Other Name: Jevtana

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Histologically confirmed primary transitional cell carcinoma (TCC) of the urinary bladder
  • T2 to T4 disease, N0 M0 determined by computerised tomography (CT) imaging and biopsy or transurethral resection
  • Eastern Co-operative Oncology Group (ECOG) Performance status 0 or 1
  • Glomerular filtration rate (GFR) ≥60ml/min.
  • Written, informed consent

Exclusion Criteria

  • ECOG Performance Status ≥ 2
  • Lymph node involvement or metastatic disease
  • Prior surgery (except transurethral resection of bladder tumour), radiation, che-motherapy, or other anti-cancer therapy within 4 weeks prior to enrolment
  • Active Grade ≥2 peripheral neuropathy
  • Active secondary cancers
  • History of severe hypersensitivity reaction (≥Grade 3) to polysorbate 80 containing drugs
  • Other concurrent serious illness or medical conditions
  • Inadequate organ function as evidenced by peripheral blood counts at enrolment:
  • Electrocardiogram (ECG) evidence of uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension, history of congestive heart failure, or myocardial infarction within last 6 months.
  • Uncontrolled diabetes mellitus.
  • Active uncontrolled gastro-oesophageal reflux disease (GORD).
  • Active infection requiring systemic antibiotic or anti-fungal medication
  • Participation in another clinical trial with any investigational drug within 30 days prior to study enrolment.
  • Concurrent or planned treatment with strong inhibitors of cytochrome P450 3A4/5. A 1-week washout period is necessary for patients who are already on these treatments.
  • Concurrent or planned treatment with strong inducers of cytochrome P450 3A4/5. A 1-week washout period is necessary for patients who are already on these treatments.
  • Contraindications to cisplatin.
  • Patient with reproductive potential not implementing an accepted and effective method of contraception.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616875

Contacts
Contact: Amit Bahl 0117 342 3213 amit.bahl@uhbristol.nhs.uk
Contact: Susan Masson 0117 342 23221 susan.masson@uhbristol.nhs.uk

Locations
United Kingdom
Bristol Haematology + Oncology Centre, Horfield Road Recruiting
Bristol, United Kingdom, BS2 8ED
Contact: Sylvia Pearson    0117 3424263    sylvia.pearson@uhbristol.nhs.uk   
Contact: Seonaid Wright    0117 342 2069    seonaid.wright@uhbristol.nhs.uk   
Principal Investigator: Amit K Bahl         
Sub-Investigator: Susan Masson         
Sponsors and Collaborators
United Bristol Healthcare NHS Trust
Sanofi
Investigators
Principal Investigator: Amit K Bahl University Hospitals Bristol NHS Foundation Trust
  More Information

No publications provided

Responsible Party: United Bristol Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT01616875     History of Changes
Other Study ID Numbers: ON/2011/3775, 2011-004090-82
Study First Received: May 17, 2012
Last Updated: June 8, 2012
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service

Keywords provided by United Bristol Healthcare NHS Trust:
Bladder cancer
Transitional cell carcinoma
Urothelial cancer
Cisplatin
Cabazitaxel
Chemotherapy
Neo adjuvant chemotherapy

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 21, 2014