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

Phase 3

Completed

• Conditions: Urinary Bladder Neoplasms
• Interventions: Drug: larotaxel (XRP9881); Drug: gemcitabine; Drug: cisplatin

• Registration Number: NCT00625664
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-19
• Study First Submitted QC: 2008-02-19
• Study First Posted: 2008-02-28
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2016-04
• Disposition First Submitted: 2016-04-06
• Disposition First Submitted QC: 2016-04-06
• Last Update Submitted: 2016-04-06
• Disposition First Posted: 2016-05-05
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 337

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	larotaxel (XRP9881)	-
1	cisplatin	-
2	gemcitabine	-
2	cisplatin	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

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

Sanofi-Aventis Investigational Site Number 840003; 🇺🇸 Sacramento, California, United States

Sanofi-Aventis Investigational Site Number 840005; 🇺🇸 San Bernardino, California, United States

Sanofi-Aventis Investigational Site Number 840033; 🇺🇸 San Diego, California, United States

Sanofi-Aventis Investigational Site Number 840031; 🇺🇸 Denver, Colorado, United States

Sanofi-Aventis Investigational Site Number 840032; 🇺🇸 Stamford, Connecticut, United States

Scroll for more (150 remaining)