Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer - CILAB

• Conditions: ocally Advanced/Metastatic Urothelial Tract or Bladder Cancer; MedDRA version: 9.1Level: LLTClassification code 10005003Term: Bladder cancer

• Registration Number: EUCTR2007-001943-23-GB
• Lead Sponsor: Sanofi-Aventis Recherche et Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-07
• Last Update Posted: 3 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 900

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 < ou = 2.

- No prior palliative chemotherapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Age < 18 years old.
- Disease localized only to the radiation fields without radiologically confirmed progression of the disease within the radiation fields after completion of prior radiotherapy.

PRIOR THERAPY:
- Time between end of (Neo)adjuvant chemotherapy and relapse < 6 months
- Less than 6 weeks or 3 weeks respectively from prior radiotherapy or surgery to time of randomization. Patients pN+ with no residual disease after surgery are not eligible.
- Treatment with an investigational agent within 4 weeks (6 weeks for immunotherapy) of study enrollment

BIOLOGICAL CRITERIA:
- Total Bilirubin > 1.0 x UNL
- Creatinine > ou = 1.0 x UNL, or actual creatinine clearance < 60 ml/min if creatinine > 1.0 x UNL and < ou = 1.5 UNL

PAST or CURRENT HISTORY
- Symptomatic brain metastases or leptomeningeal disease
- History of another neoplasm except non metastatic melanoma skin cancer, carcinoma in situ of the cervix, or cancer cured by surgery, small field radiation or chemotherapy < 5 years prior to randomization.
- Prior cisplatin as (neo)adjuvant chemotherapy with cumulative dose> 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.
- Any other active illness such as 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. For patients who were receiving treatment with such agents, a one-week washout period is required prior to randomization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare Overall Survival (OS) of patients administered Larotaxel 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.<br><br>- To assess the safety and tolerability of Larotaxel in combination with cisplatin and gemcitabine with cisplatin.<br><br>- To assess the pharmacokinetics of Larotaxel and cisplatin in this patient population (in selected centers).;Primary end point(s): Overall Survival (OS)