Have you or your loved ones been diagnosed with infiltrating bladder urothelial carcinoma?

You may be eligible to participate in a infiltrating bladder urothelial carcinoma clinical trial.

Have you or your loved ones been diagnosed with infiltrating bladder urothelial carcinoma? You may be eligible to participate in a infiltrating bladder urothelial carcinoma clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Infiltrating Bladder Urothelial Carcinoma Clinical Trial in Bristol

NCT01616875 | Phase 2 | Interventional

Have you or your loved ones been diagnosed with infiltrating bladder urothelial carcinoma?

You may be eligible to participate in a infiltrating bladder urothelial carcinoma clinical trial.

Have you or your loved ones been diagnosed with infiltrating bladder urothelial carcinoma? You may be eligible to participate in a infiltrating bladder urothelial carcinoma clinical trial.

Active not recruiting

Male & Female

18 Years +

This study has recruited 28 Participants

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

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Details for the study

Brief Title

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

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

Treatments and/or Procedures

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Secondary

Overall survival

From the date of registration to the date of death from any cause.

Up to 5 years following radical cystectomy

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

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 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

Study 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.