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Clinical Trials/NCT00625664
NCT00625664CompletedPhase 3

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

Sanofi160 sites in 1 country337 target enrollmentStarted: February 2008Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Sanofi
Enrollment
337
Locations
160
Primary Endpoint
Overall survival defined as the time interval from the date of randomization to the date of death due to any cause

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

1

Experimental

Intervention: larotaxel (XRP9881) (Drug)

1

Experimental

Intervention: cisplatin (Drug)

2

Active Comparator

Intervention: gemcitabine (Drug)

2

Active Comparator

Intervention: cisplatin (Drug)

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)(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)

Investigators

Sponsor
Sanofi
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (160)

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Larotaxel + Cisplatin Versus Gemcitabine +... | Clinical Trial