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A Phase II Trial of Combination Cabazitaxel and Cisplatin Chemotherapy in the Neo-adjuvant Treatment of Transitional Cell Carcinoma of the Urinary Bladder


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Infiltrating Bladder Urothelial Carcinoma

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Trial Information

A Phase II Trial of Combination Cabazitaxel and Cisplatin Chemotherapy in the Neo-adjuvant Treatment of Transitional Cell Carcinoma of the Urinary Bladder


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall pathological response rate

Outcome Time Frame:

Histological assessment of radical cystectomy specimen expected to be 15 weeks after commencing study chemotherapy

Safety Issue:

No

Principal Investigator

Amit K Bahl

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospitals Bristol NHS Foundation Trust

Authority:

United Kingdom: Research Ethics Committee

Study ID:

ON/2011/3775

NCT ID:

NCT01616875

Start Date:

May 2012

Completion Date:

May 2017

Related Keywords:

  • Infiltrating Bladder Urothelial Carcinoma
  • Bladder cancer
  • Transitional cell carcinoma
  • Urothelial cancer
  • Cisplatin
  • Cabazitaxel
  • Chemotherapy
  • Neo adjuvant chemotherapy
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell

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