Clinical trial NCT01616875: Bristol Bladder 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Infiltrating Bladder Urothelial Carcinoma
Keywords: Bladder cancer
Transitional cell carcinoma
Urothelial cancer
Cisplatin
Cabazitaxel
Chemotherapy
Neo adjuvant chemotherapy
Lead sponsor: University Hospitals Bristol and Weston NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2012-06-12
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility 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.

Primary outcomes:
measure: Overall pathological response rate
timeFrame: Histological assessment of radical cystectomy specimen expected to be 15 weeks after commencing study chemotherapy
Secondary outcomes:
measure: To record progression free survival
timeFrame: Up to 5 years following radical cystectomy
measure: To assess quality of life
timeFrame: Up to 13 weeks from baseline
measure: To record side effects and tolerability of treatment
timeFrame: Up to 13 weeks from baseline
measure: Overall survival
timeFrame: Up to 5 years following radical cystectomy
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Bristol Haematology + Oncology Centre, Horfield Road
Study officials:
affiliation: University Hospitals Bristol and Weston NHS Foundation Trust
name: Amit K Bahl
role: PRINCIPAL_INVESTIGATOR
References: