Bristol Bladder Trial

Infiltrating Bladder Urothelial Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01616875
• Other study ID #: ON/2011/3775
• Secondary ID: 2011-004090-82
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 2012
• Est. completion date: January 2023

Study information

• Verified date: May 2019
• Source: University Hospitals Bristol NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: January 2023
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Infiltrating Bladder Urothelial Carcinoma

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Bristol Haematology + Oncology Centre, Horfield Road	Bristol

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Bristol NHS Foundation Trust	Sanofi

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall pathological response rate		Histological assessment of radical cystectomy specimen expected to be 15 weeks after commencing study chemotherapy
Secondary	To record progression free survival	From date of registration until the date of first documented progression or date of death from any cause whichever came first.	Up to 5 years following radical cystectomy
Secondary	To assess quality of life	EQ-5D and EORTC QLQC30 and BLM30 will be assessed at baseline and following each cycle of chemotherapy	Up to 13 weeks from baseline
Secondary	To record side effects and tolerability of treatment	Common toxicity criteria adverse events (CTC AE ) Version 4.03 will be assessed at baseline and following each cycle of chemotherapy	Up to 13 weeks from baseline
Secondary	Overall survival	From the date of registration to the date of death from any cause.	Up to 5 years following radical cystectomy