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Bristol Bladder Trial
Conditions
Infiltrating Bladder Urothelial Carcinoma
Conditions: official terms
Carcinoma - Carcinoma, Transitional Cell - Urinary Bladder Neoplasms
Conditions: Keywords
Bladder cancer, Transitional cell carcinoma, Urothelial cancer, Cisplatin, Cabazitaxel, Chemotherapy, Neo adjuvant chemotherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Cabazitaxel + Cisplatin chemotherapy
Type: Drug
Overall Status
Recruiting
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
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
- 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.
Location
Bristol Haematology + Oncology Centre, Horfield Road
Bristol, United Kingdom
Status: Recruiting
Contact: Sylvia Pearson - 0117 3424263 - sylvia.pearson@uhbristol.nhs.uk
Start Date
May 2012
Completion Date
May 2017
Sponsors
University Hospitals Bristol NHS Foundation Trust
Source
University Hospitals Bristol NHS Foundation Trust
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page