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Completed

NCT Number: NCT00625664

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

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.

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Key information

Conditions

Urinary Bladder Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Investigational Site Number 032002, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Larotaxel (XRP9881)

Drug

administered on day 1 as a 1-hour infusion

Gemcitabine

Drug

administered on day 1, 8 and 15 as a 30-minute infusion

Cisplatin

Drug

1 hour infusion administered on day 1, 30 minutes after the other treatment

Primary outcomes

  1. 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

  1. 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

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

    Time frame: at screening and every cycle

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Acronym: CILAB

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 28, 2008
Registry last updated
May 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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