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

Study Overview
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Brief Summary
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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.

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

Conditions
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Urinary Bladder Neoplasms

Intervention / Treatment
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* Drug: larotaxel (XRP9881)
* Drug: gemcitabine
* Drug: cisplatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: larotaxel (XRP9881)<br>* administered on day 1 as a 1-hour infusion<br>Drug: cisplatin<br>* 1 hour infusion administered on day 1, 30 minutes after the other treatment<br>|
| Active Comparator: 2<br> | Drug: gemcitabine<br>* administered on day 1, 8 and 15 as a 30-minute infusion<br>Drug: cisplatin<br>* 1 hour infusion administered on day 1, 30 minutes after the other treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival defined as the time interval from the date of randomization to the date of death due to any cause |  | study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological tumor assessments (CT/MRI) |  | 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 |  | at screening and every cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasms, Cancer, Bladder, Urothelial Tract