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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00625664
First received: February 19, 2008
Last updated: September 14, 2011
Last verified: September 2011
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Adverse Events, laboratory assessments, vital signs, Physical Examinations, and ECOG Performance Status [ Time Frame: at screening and every cycle ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625664

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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00625664     History of Changes
Other Study ID Numbers: EFC6668, EUDRACT: 2007-001943-23
Study First Received: February 19, 2008
Last Updated: September 14, 2011
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Sanofi:
Cancer
Neoplasms
Bladder
Urothelial Tract

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

ClinicalTrials.gov processed this record on October 29, 2014