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

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: February 19, 2008
Last updated: April 6, 2016
Last verified: April 2016
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.

Condition Intervention Phase
Urinary Bladder Neoplasms
Drug: larotaxel (XRP9881)
Drug: gemcitabine
Drug: cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 337
Study Start Date: February 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: larotaxel (XRP9881)
administered on day 1 as a 1-hour infusion
Drug: cisplatin
1 hour infusion administered on day 1, 30 minutes after the other treatment
Active Comparator: 2 Drug: gemcitabine
administered on day 1, 8 and 15 as a 30-minute infusion
Drug: cisplatin
1 hour infusion administered on day 1, 30 minutes after the other treatment


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.

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Please refer to this study by its identifier: NCT00625664

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Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi Identifier: NCT00625664     History of Changes
Other Study ID Numbers: EFC6668
EUDRACT: 2007-001943-23
Study First Received: February 19, 2008
Last Updated: April 6, 2016

Keywords provided by Sanofi:
Urothelial Tract

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017