Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer MedDRA version: 9.1 Level: LLT Classification code 10005003 Term: Bladder cancer
Conditions
Interventions
Product Name: Larotaxel(RPR109881A)
Product Code: XRP9881
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Larotaxel dihydrate
CAS Number: 192573-38-9
Current Sponsor co
Sponsors
Sanofi-Aventis Recherche et Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) with locally advanced (T4b) or metastatic (lymph node or visceral) urothelial tract or bladder cancer. - ECOG Performans Status =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Age 2.5 x UNL, or AP > 2.5 x UNL and = 5.0 x UNL associated with AST/ALT > 1.5 UNL or AP > 5.0 x UNL - Total Bilirubin > 1.0 x UNL - Creatinine > ou = 1.0 x UNL, or actual creatinine clearance 1.0 x UNL and 300 mg/m² - Peripheral neuropathy > grade 1 - History of inflammatory bowel disease, significant bowel obstruction. - History of hypersensitivity to platinum, gemcitabine, taxanes, polysorbate 80, or to compounds with similar chemical structures. - Known human immunodeficiency virus (HIV) infection immunodeficiency-syndrome (AIDS)-related illness. - Any other as active illness such as active uncontrolled infections, uncontrolled cardiac disease or hypertension, uncontrolled diabetes that would preclude safe administration of study therapy at the time of randomization (...) CONCOMITANT TREATMENT - Concurrent treatment with strong inhibitors of CYP P450 3A4 or patients planning to receive these treatments. For patients who were receiving treatment with such agents, a one-week washout period is required prior to randomization - Concurrent treatment with strong inhibitors of cytochrome P450 2C8 (gemfibrozile) or patients planning to receive this treatment. For patients who were receiving treatment with such agent, a one-week washout period is required prior to randomization. Others Refer to the Protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare Overall Survival (OS) of patients administered Larotaxel in combination with cisplatin versus gemcitabine in combination with cisplatin for the treatment of locally advanced/metastatic urothelial tract or bladder cancer;Secondary Objective: - To compare Progression Free Survival (PFS), Objective Response Rate (ORR), time to definitive deterioration of PS, Duration of Response (DR), and time to definitive 5% weight loss of larotaxel in combination with cisplatin vs. gemcitabine combined with cisplatin. - To assess the safety and tolerability of Larotaxel in combination with cisplatin and gemcitabine with cisplatin. - To assess the pharmacokinetics of Larotaxel and cisplatin in this patient population (in selected centers).;Primary end point(s): Overall Survival (OS) | — |
Countries
France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed