Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer

Sanofi337 enrolled

Overview

This is a randomized, open-label, multi-center study comparing the efficacy and safety of XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally advanced/metastatic urothelial tract or bladder cancer. The primary objective is to compare overall survival. Secondary objectives include comparisons of progression free survival, objective response rate, time to definitive deterioration of performance status, duration of response, time to definitive weight loss, and assessments of overall safety, and pharmacokinetics. Patients are treated until disease progression, death, or unacceptable toxicity and are followed-up until death or the end of the study whichever comes first.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

337

Conditions

Urinary Bladder Neoplasms

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) with locally advanced (T4b) or metastatic urothelial tract or bladder cancer * ECOG Performance Status 0 or 1 * No prior palliative chemotherapy Exclusion Criteria: * (Neo)Adjuvant chemotherapy if \< 6 months between end of (neo)adjuvant chemotherapy and relapse * Less than 6 weeks elapsed from prior radiotherapy and less than 3 weeks from surgery to time of randomization * Prior cisplatin as (neo)adjuvant chemotherapy with cumulative dose \> 300 mg/m² The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (160)

Sanofi-Aventis Investigational Site Number 840068

Anchorage, Alaska, United States

Sanofi-Aventis Investigational Site Number 840035

Berkeley, California, United States

Sanofi-Aventis Investigational Site Number 840012

Burbank, California, United States

Sanofi-Aventis Investigational Site Number 840029

La Jolla, California, United States

Sanofi-Aventis Investigational Site Number 840046

Los Angeles, California, United States

Outcomes

Primary Outcomes

Overall survival defined as the time interval from the date of randomization to the date of death due to any cause

Time frame: study period

Secondary Outcomes

Radiological tumor assessments (CT/MRI)

Time frame: at screening, every 8 weeks during treatment, at end of treatment, and in follow-up until documented disease progression

Adverse Events, laboratory assessments, vital signs, Physical Examinations, and ECOG Performance Status

Time frame: at screening and every cycle