ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00625664
Recruitment Status : Completed
First Posted : February 28, 2008
Last Update Posted : May 5, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Urinary Bladder Neoplasms Drug: larotaxel (XRP9881) Drug: gemcitabine Drug: cisplatin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 337 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2008
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625664


  Show 160 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00625664     History of Changes
Other Study ID Numbers: EFC6668
EUDRACT: 2007-001943-23
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: April 2016

Keywords provided by Sanofi:
Cancer
Neoplasms
Bladder
Urothelial Tract

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs