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-IT
• Lead Sponsor: Sanofi-Aventis Recherche et De'veloppement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-12
• 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 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 - 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 calculated 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. - History of inflammatory bowel disease, significant bowel obstruction. - History of hypersensitivity grade 3 to platinum, gemcitabine or 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