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

NCT00625664 | Completed Phase 3

• 2 other identifiers: EFC6668EUDRACT: 2007-001943-23
• Study Type: interventional
• Target: 337
• Locations: 19 countries
• Sites: 160

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.

Conditions

Urinary Bladder Neoplasms

Keywords

Cancer; Neoplasms; Bladder; Urothelial Tract

Outcome Measures

Primary Outcomes (1)

• Overall survival defined as the time interval from the date of randomization to the date of death due to any cause

  study period

Secondary Outcomes (2)

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: larotaxel (XRP9881); Drug: cisplatin

2

ACTIVE COMPARATOR

Drug: gemcitabine; Drug: cisplatin

Interventions

larotaxel (XRP9881) DRUG

administered on day 1 as a 1-hour infusion

1

gemcitabine DRUG

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

2

cisplatin DRUG

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

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (160)

Sanofi-Aventis Investigational Site Number 840068

Anchorage, Alaska, 99508, United States

Location

Sanofi-Aventis Investigational Site Number 840035

Berkeley, California, 94704, United States

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Sanofi-Aventis Investigational Site Number 840012

Burbank, California, 91505, United States

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Sanofi-Aventis Investigational Site Number 840029

La Jolla, California, 92037, United States

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Sanofi-Aventis Investigational Site Number 840046

Los Angeles, California, 90033, United States

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Sanofi-Aventis Investigational Site Number 840003

Sacramento, California, 95817, United States

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Sanofi-Aventis Investigational Site Number 840005

San Bernardino, California, 92404, United States

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Sanofi-Aventis Investigational Site Number 840033

San Diego, California, 92103, United States

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Sanofi-Aventis Investigational Site Number 840031

Denver, Colorado, 80262, United States

Location

Sanofi-Aventis Investigational Site Number 840032

Stamford, Connecticut, 06902, United States

Location

Sanofi-Aventis Investigational Site Number 840034

Washington D.C., District of Columbia, 20007, United States

Location

Sanofi-Aventis Investigational Site Number 840021

Washington D.C., District of Columbia, 20010, United States

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Sanofi-Aventis Investigational Site Number 840001

Boca Raton, Florida, 33486, United States

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Sanofi-Aventis Investigational Site Number 840048

Boynton Beach, Florida, 33435, United States

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Sanofi-Aventis Investigational Site Number 840049

Jacksonville, Florida, 32224, United States

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Sanofi-Aventis Investigational Site Number 840061

Lakeland, Florida, 33805, United States

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Sanofi-Aventis Investigational Site Number 840060

Athens, Georgia, 30607, United States

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Sanofi-Aventis Investigational Site Number 840030

Boise, Idaho, 83712, United States

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Sanofi-Aventis Investigational Site Number 840024

Maywood, Illinois, 60153, United States

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Sanofi-Aventis Investigational Site Number 840062

Peoria, Illinois, 61615, United States

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Sanofi-Aventis Investigational Site Number 840039

Goshen, Indiana, 46526, United States

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Sanofi-Aventis Investigational Site Number 840054

Kansas City, Kansas, 66160-7321, United States

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Sanofi-Aventis Investigational Site Number 840057

Paducah, Kentucky, 42002, United States

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Sanofi-Aventis Investigational Site Number 840004

Metarie, Louisiana, 70006-290, United States

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Sanofi-Aventis Investigational Site Number 840045

Baltimore, Maryland, 21201, United States

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Sanofi-Aventis Investigational Site Number 840006

Detroit, Michigan, 48201, United States

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Sanofi-Aventis Investigational Site Number 840026

Lansing, Michigan, 48510, United States

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Sanofi-Aventis Investigational Site Number 840047

Saint Joseph, Michigan, 49805, United States

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Sanofi-Aventis Investigational Site Number 840009

Hackensack, New Jersey, 07601, United States

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Sanofi-Aventis Investigational Site Number 840044

Lake Success, New York, 11042, United States

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Sanofi-Aventis Investigational Site Number 840013

New York, New York, 10021, United States

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Sanofi-Aventis Investigational Site Number 840050

New York, New York, 10032, United States

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Sanofi-Aventis Investigational Site Number 840056

Rochester, New York, 14642, United States

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Sanofi-Aventis Investigational Site Number 840015

Syracuse, New York, 13210, United States

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Sanofi-Aventis Investigational Site Number 840041

Chapel Hill, North Carolina, 27599, United States

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Sanofi-Aventis Investigational Site Number 840007

Charlotte, North Carolina, 28204, United States

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Sanofi-Aventis Investigational Site Number 840019

Sylvania, Ohio, 43560, United States

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Sanofi-Aventis Investigational Site Number 840020

Bethlehem, Pennsylvania, 18015, United States

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Sanofi-Aventis Investigational Site Number 840065

Dunmore, Pennsylvania, 18512, United States

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Sanofi-Aventis Investigational Site Number 840058

Woonsocket, Rhode Island, 02895, United States

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Sanofi-Aventis Investigational Site Number 840052

Charleston, South Carolina, 29406, United States

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Sanofi-Aventis Investigational Site Number 840002

Knoxville, Tennessee, 37920, United States

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Sanofi-Aventis Investigational Site Number 840008

Houston, Texas, 77014, United States

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Sanofi-Aventis Investigational Site Number 840018

Houston, Texas, 77030, United States

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Sanofi-Aventis Investigational Site Number 840017

Lubbock, Texas, 79415, United States

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Sanofi-Aventis Investigational Site Number 840016

San Antonio, Texas, 78229, United States

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Sanofi-Aventis Investigational Site Number 840064

Temple, Texas, 76508, United States

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Sanofi-Aventis Investigational Site Number 840010

The Woodlands, Texas, 77380, United States

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Sanofi-Aventis Investigational Site Number 840036

Seattle, Washington, 98111, United States

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Sanofi-Aventis Investigational Site Number 840011

Madison, Wisconsin, 53792, United States

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Sanofi-Aventis Investigational Site Number 840025

Marshfield, Wisconsin, 54449, United States

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Sanofi-Aventis Investigational Site Number 840038

Milwaukee, Wisconsin, 53226, United States

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Sanofi-Aventis Investigational Site Number 032002

Buenos Aires, C1120AAT, Argentina

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Sanofi-Aventis Investigational Site Number 032003

Ciudad de Buenos Aires, C1426BOR, Argentina

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Sanofi-Aventis Investigational Site Number 032004

Mendoza, 5500, Argentina

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Sanofi-Aventis Investigational Site Number 032005

Rosario, 2000, Argentina

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Sanofi-Aventis Investigational Site Number 032001

Santa Fe, 3000, Argentina

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Sanofi-Aventis Investigational Site Number 036002

Adelaide, 5000, Australia

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Sanofi-Aventis Investigational Site Number 036003

Bedford Park, 5042, Australia

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Sanofi-Aventis Investigational Site Number 036004

St Leonards, 2065, Australia

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Sanofi-Aventis Investigational Site Number 056005

Aalst, 9300, Belgium

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Sanofi-Aventis Investigational Site Number 056001

Brussels, 1000, Belgium

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Sanofi-Aventis Investigational Site Number 056002

Brussels, 1200, Belgium

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Sanofi-Aventis Investigational Site Number 056004

Ottignies, 1340, Belgium

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Sanofi-Aventis Investigational Site Number 056003

Wilrijk, 2610, Belgium

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Sanofi-Aventis Investigational Site Number 056006

Yvoir, 5530, Belgium

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Sanofi-Aventis Investigational Site Number 076006

Barretos, 14784-400, Brazil

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Sanofi-Aventis Investigational Site Number 076004

Florianópolis, 88034-000, Brazil

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Sanofi-Aventis Investigational Site Number 076001

Porto Alegre, 90110-270, Brazil

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Sanofi-Aventis Investigational Site Number 076003

Porto Alegre, 90610-000, Brazil

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Sanofi-Aventis Investigational Site Number 076002

Rio de Janeiro, 20231-050, Brazil

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Sanofi-Aventis Investigational Site Number 076007

São Paulo, 01246-000, Brazil

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Sanofi-Aventis Investigational Site Number 076005

São Paulo, 04122 000, Brazil

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Sanofi-Aventis Investigational Site Number 124007

Edmonton, T6G1Z2, Canada

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Sanofi-Aventis Investigational Site Number 124001

London, N6A 4L6, Canada

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Sanofi-Aventis Investigational Site Number 124006

Montreal, H2L 4M1, Canada

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Sanofi-Aventis Investigational Site Number 124003

Québec, G1R 2J6, Canada

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Sanofi-Aventis Investigational Site Number 124002

Weston, M9N 1N8, Canada

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Sanofi-Aventis Investigational Site Number 152001

Santiago, 8380455, Chile

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Sanofi-Aventis Investigational Site Number 250006

Avignon, 84082, France

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Sanofi-Aventis Investigational Site Number 250003

Bordeaux, 33076, France

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Sanofi-Aventis Investigational Site Number 250005

Hyères, 83400, France

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Sanofi-Aventis Investigational Site Number 250011

Le Mans, 72015, France

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Sanofi-Aventis Investigational Site Number 250004

Lyon, 69008, France

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Sanofi-Aventis Investigational Site Number 250012

Perpignan, 66012, France

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Sanofi-Aventis Investigational Site Number 250007

Poitiers, 86021, France

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Sanofi-Aventis Investigational Site Number 250008

Saint-Herblain, 44805, France

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Sanofi-Aventis Investigational Site Number 250009

Strasbourg, 67091, France

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Sanofi-Aventis Investigational Site Number 250001

Suresnes, 92151, France

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Sanofi-Aventis Investigational Site Number 356003

Bangalore, 560029, India

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Sanofi-Aventis Investigational Site Number 356007

Kolkata, 700026, India

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Sanofi-Aventis Investigational Site Number 356004

New Delhi, 110 029, India

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Sanofi-Aventis Investigational Site Number 356001

New Delhi, 110001, India

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Sanofi-Aventis Investigational Site Number 356002

Vellore, 632004, India

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Sanofi-Aventis Investigational Site Number 356005

Visakhapatnam, 530002, India

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Sanofi-Aventis Investigational Site Number 376005

Haifa, 31096, Israel

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Sanofi-Aventis Investigational Site Number 376004

Kfar Saba, 44281, Israel

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Sanofi-Aventis Investigational Site Number 376003

Petah Tikva, 49100, Israel

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Sanofi-Aventis Investigational Site Number 376002

Tel Aviv, 64239, Israel

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Sanofi-Aventis Investigational Site Number 376007

Tel Litwinsky, 52621, Israel

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Sanofi-Aventis Investigational Site Number 376001

Tzrifin, 70300, Israel

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Sanofi-Aventis Investigational Site Number 380004

Bari, 70124, Italy

Location

Sanofi-Aventis Investigational Site Number 380003

Lecce, 73100, Italy

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Sanofi-Aventis Investigational Site Number 380005

Meldola, 47014, Italy

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Sanofi-Aventis Investigational Site Number 380006

Pavia, 27100, Italy

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Sanofi-Aventis Investigational Site Number 380002

Perugia, 06128, Italy

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Sanofi-Aventis Investigational Site Number 380001

Roma, 00152, Italy

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Sanofi-Aventis Investigational Site Number 380008

Viterbo, 01100, Italy

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Sanofi-Aventis Investigational Site Number 484003

Aguascalientes, 20230, Mexico

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Sanofi-Aventis Investigational Site Number 484007

Chihuahua City, 31000, Mexico

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Sanofi-Aventis Investigational Site Number 484005

Chihuahua City, 31205, Mexico

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Sanofi-Aventis Investigational Site Number 484004

Monterrey, 64988, Mexico

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Sanofi-Aventis Investigational Site Number 528005

Amsterdam, 1091 HA, Netherlands

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Sanofi-Aventis Investigational Site Number 528002

Arnhem, 6815 AD, Netherlands

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Sanofi-Aventis Investigational Site Number 528006

Hoofddorp, 2134 TM, Netherlands

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Sanofi-Aventis Investigational Site Number 528003

Maastricht, 6229 HX, Netherlands

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Sanofi-Aventis Investigational Site Number 528004

Nijmegen, 6525 GA, Netherlands

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Sanofi-Aventis Investigational Site Number 528001

Sittard-Geleen, 6162 BG, Netherlands

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Sanofi-Aventis Investigational Site Number 528007

Zwolle, 8025 AB, Netherlands

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Sanofi-Aventis Investigational Site Number 616002

Poznan, 61-485, Poland

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Sanofi-Aventis Investigational Site Number 616004

Rybnik, 44-200, Poland

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Sanofi-Aventis Investigational Site Number 616001

Warsaw, 02-781, Poland

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Sanofi-Aventis Investigational Site Number 616005

Wroclaw, 51-124, Poland

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Sanofi-Aventis Investigational Site Number 643009

Chelyabinsk, 454087, Russia

Location

Sanofi-Aventis Investigational Site Number 643010

Kursk, 305035, Russia

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Sanofi-Aventis Investigational Site Number 643006

Moscow, 105425, Russia

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Sanofi-Aventis Investigational Site Number 643008

Moscow, 115478, Russia

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Sanofi-Aventis Investigational Site Number 643004

Moscow, 117837, Russia

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Sanofi-Aventis Investigational Site Number 643005

Moscow, 125284, Russia

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Sanofi-Aventis Investigational Site Number 643001

Obninsk, 249036, Russia

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Sanofi-Aventis Investigational Site Number 643002

Saint Petersburg, 191104, Russia

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Sanofi-Aventis Investigational Site Number 643003

Saint Petersburg, 194354, Russia

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Sanofi-Aventis Investigational Site Number 643007

Saint Petersburg, 197758, Russia

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Sanofi-Aventis Investigational Site Number 643011

Saint Petersburg, 197758, Russia

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Sanofi-Aventis Investigational Site Number 710008

Bloemfontein, 9301, South Africa

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Sanofi-Aventis Investigational Site Number 710003

Cape Town, 7506, South Africa

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Sanofi-Aventis Investigational Site Number 710001

Cape Town, 7956, South Africa

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Sanofi-Aventis Investigational Site Number 710007

Durban, 4062, South Africa

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Sanofi-Aventis Investigational Site Number 710009

Durban, 4091, South Africa

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Sanofi-Aventis Investigational Site Number 710006

Port Elizabeth, 6001, South Africa

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Sanofi-Aventis Investigational Site Number 710005

Pretoria, 0181, South Africa

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Sanofi-Aventis Investigational Site Number 724006

Badalona, 08916, Spain

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Sanofi-Aventis Investigational Site Number 724001

Barcelona, 08003, Spain

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Sanofi-Aventis Investigational Site Number 724004

Barcelona, 08025, Spain

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Sanofi-Aventis Investigational Site Number 724008

Barcelona, 08035, Spain

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Sanofi-Aventis Investigational Site Number 724002

Barcelona, 08036, Spain

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Sanofi-Aventis Investigational Site Number 724003

Madrid, 28041, Spain

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Sanofi-Aventis Investigational Site Number 724010

Oviedo, 33006, Spain

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Sanofi-Aventis Investigational Site Number 724013

Palma de Mallorca, 07014, Spain

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Sanofi-Aventis Investigational Site Number 724007

Palma de Mallorca, 07198, Spain

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Sanofi-Aventis Investigational Site Number 724009

Pamplona, 31008, Spain

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Sanofi-Aventis Investigational Site Number 724011

Santiago de Compostela, 15706, Spain

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Sanofi-Aventis Investigational Site Number 724012

Zaragoza, 50009, Spain

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Sanofi-Aventis Investigational Site Number 752001

Umeå, 901 85, Sweden

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Sanofi-Aventis Investigational Site Number 752002

Uppsala, 751 85, Sweden

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Sanofi-Aventis Investigational Site Number 792002

Ankara, 06100, Turkey (Türkiye)

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Sanofi-Aventis Investigational Site Number 792003

Ankara, 065090, Turkey (Türkiye)

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Sanofi-Aventis Investigational Site Number 792004

Ankara, 61080, Turkey (Türkiye)

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Sanofi-Aventis Investigational Site Number 792006

Istanbul, 22030, Turkey (Türkiye)

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Sanofi-Aventis Investigational Site Number 792001

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Neoplasms

Interventions

larotaxel; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 28, 2008
• Study Start: February 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: May 5, 2016

Record last verified: 2016-04

Locations

ES (12); SE (2); CL (1); BE (6); US (52); NL (7); AU (3); BR (7); RU (11); CA (5); IN (6); ME (4); PL (4); ZA (7); TU (5); IL (6); FR (10); AR (5); IT (7)