Urinary Bladder Neoplasms Clinical Trial
— CILABOfficial 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
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.
| Status | Completed |
| Enrollment | 337 |
| Est. completion date | February 2011 |
| Est. primary completion date | February 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Sanofi-Aventis Investigational Site Number 032002 | Buenos Aires | |
| Argentina | Sanofi-Aventis Investigational Site Number 032003 | Ciudad De Buenos Aires | |
| Argentina | Sanofi-Aventis Investigational Site Number 032004 | Mendoza | |
| Argentina | Sanofi-Aventis Investigational Site Number 032005 | Rosario | |
| Argentina | Sanofi-Aventis Investigational Site Number 032001 | Santa Fe | |
| Australia | Sanofi-Aventis Investigational Site Number 036002 | Adelaide | |
| Australia | Sanofi-Aventis Investigational Site Number 036003 | Bedford Park | |
| Australia | Sanofi-Aventis Investigational Site Number 036004 | St Leonards | |
| Belgium | Sanofi-Aventis Investigational Site Number 056005 | Aalst | |
| Belgium | Sanofi-Aventis Investigational Site Number 056001 | Bruxelles | |
| Belgium | Sanofi-Aventis Investigational Site Number 056002 | Bruxelles | |
| Belgium | Sanofi-Aventis Investigational Site Number 056004 | Ottignies | |
| Belgium | Sanofi-Aventis Investigational Site Number 056003 | Wilrijk | |
| Belgium | Sanofi-Aventis Investigational Site Number 056006 | Yvoir | |
| Brazil | Sanofi-Aventis Investigational Site Number 076006 | Barretos | |
| Brazil | Sanofi-Aventis Investigational Site Number 076004 | Florianopolis | |
| Brazil | Sanofi-Aventis Investigational Site Number 076001 | Porto Alegre | |
| Brazil | Sanofi-Aventis Investigational Site Number 076003 | Porto Alegre | |
| Brazil | Sanofi-Aventis Investigational Site Number 076002 | Rio De Janeiro | |
| Brazil | Sanofi-Aventis Investigational Site Number 076005 | Sao Paulo | |
| Brazil | Sanofi-Aventis Investigational Site Number 076007 | Sao Paulo | |
| Canada | Sanofi-Aventis Investigational Site Number 124007 | Edmonton | |
| Canada | Sanofi-Aventis Investigational Site Number 124001 | London | |
| Canada | Sanofi-Aventis Investigational Site Number 124006 | Montreal | |
| Canada | Sanofi-Aventis Investigational Site Number 124003 | Quebec | |
| Canada | Sanofi-Aventis Investigational Site Number 124002 | Weston | |
| Chile | Sanofi-Aventis Investigational Site Number 152001 | Santiago | |
| France | Sanofi-Aventis Investigational Site Number 250006 | Avignon | |
| France | Sanofi-Aventis Investigational Site Number 250003 | Bordeaux Cedex | |
| France | Sanofi-Aventis Investigational Site Number 250005 | Hyeres | |
| France | Sanofi-Aventis Investigational Site Number 250011 | Le Mans | |
| France | Sanofi-Aventis Investigational Site Number 250004 | Lyon | |
| France | Sanofi-Aventis Investigational Site Number 250012 | Perpignan | |
| France | Sanofi-Aventis Investigational Site Number 250007 | Poitiers Cedex | |
| France | Sanofi-Aventis Investigational Site Number 250008 | Saint Herblain | |
| France | Sanofi-Aventis Investigational Site Number 250009 | Strasbourg | |
| France | Sanofi-Aventis Investigational Site Number 250001 | Suresnes | |
| India | Sanofi-Aventis Investigational Site Number 356003 | Bangalore | |
| India | Sanofi-Aventis Investigational Site Number 356007 | Kolkata | |
| India | Sanofi-Aventis Investigational Site Number 356001 | New Delhi | |
| India | Sanofi-Aventis Investigational Site Number 356004 | New Delhi | |
| India | Sanofi-Aventis Investigational Site Number 356002 | Vellore | |
| India | Sanofi-Aventis Investigational Site Number 356005 | Vishakhapatnam | |
| Israel | Sanofi-Aventis Investigational Site Number 376005 | Haifa | |
| Israel | Sanofi-Aventis Investigational Site Number 376004 | Kfar Saba | |
| Israel | Sanofi-Aventis Investigational Site Number 376003 | Petah-Tikva | |
| Israel | Sanofi-Aventis Investigational Site Number 376002 | Tel Aviv | |
| Israel | Sanofi-Aventis Investigational Site Number 376007 | Tel Hashomer | |
| Israel | Sanofi-Aventis Investigational Site Number 376001 | Tzrifin | |
| Italy | Sanofi-Aventis Investigational Site Number 380004 | Bari | |
| Italy | Sanofi-Aventis Investigational Site Number 380003 | Lecce | |
| Italy | Sanofi-Aventis Investigational Site Number 380005 | Meldola | |
| Italy | Sanofi-Aventis Investigational Site Number 380006 | Pavia | |
| Italy | Sanofi-Aventis Investigational Site Number 380002 | Perugia | |
| Italy | Sanofi-Aventis Investigational Site Number 380001 | Roma | |
| Italy | Sanofi-Aventis Investigational Site Number 380008 | Viterbo | |
| Mexico | Sanofi-Aventis Investigational Site Number 484003 | Aguascalientes | |
| Mexico | Sanofi-Aventis Investigational Site Number 484005 | Chihuahua | |
| Mexico | Sanofi-Aventis Investigational Site Number 484007 | Chihuahua | |
| Mexico | Sanofi-Aventis Investigational Site Number 484004 | Monterrey | |
| Netherlands | Sanofi-Aventis Investigational Site Number 528005 | Amsterdam | |
| Netherlands | Sanofi-Aventis Investigational Site Number 528002 | Arnhem | |
| Netherlands | Sanofi-Aventis Investigational Site Number 528006 | Hoofddorp | |
| Netherlands | Sanofi-Aventis Investigational Site Number 528003 | Maastricht | |
| Netherlands | Sanofi-Aventis Investigational Site Number 528004 | Nijmegen | |
| Netherlands | Sanofi-Aventis Investigational Site Number 528001 | Sittard-Geleen | |
| Netherlands | Sanofi-Aventis Investigational Site Number 528007 | Zwolle | |
| Poland | Sanofi-Aventis Investigational Site Number 616002 | Poznan | |
| Poland | Sanofi-Aventis Investigational Site Number 616004 | Rybnik | |
| Poland | Sanofi-Aventis Investigational Site Number 616001 | Warszawa | |
| Poland | Sanofi-Aventis Investigational Site Number 616005 | Wroclaw | |
| Russian Federation | Sanofi-Aventis Investigational Site Number 643009 | Chelyabinsk | |
| Russian Federation | Sanofi-Aventis Investigational Site Number 643010 | Kursk | |
| Russian Federation | Sanofi-Aventis Investigational Site Number 643004 | Moscow | |
| Russian Federation | Sanofi-Aventis Investigational Site Number 643005 | Moscow | |
| Russian Federation | Sanofi-Aventis Investigational Site Number 643006 | Moscow | |
| Russian Federation | Sanofi-Aventis Investigational Site Number 643008 | Moscow | |
| Russian Federation | Sanofi-Aventis Investigational Site Number 643001 | Obninsk | |
| Russian Federation | Sanofi-Aventis Investigational Site Number 643003 | Saint-Petersburg | |
| Russian Federation | Sanofi-Aventis Investigational Site Number 643007 | Saint-Petersburg | |
| Russian Federation | Sanofi-Aventis Investigational Site Number 643002 | St-Petersburg | |
| Russian Federation | Sanofi-Aventis Investigational Site Number 643011 | St-Petersburg | |
| South Africa | Sanofi-Aventis Investigational Site Number 710008 | Bloemfontein | |
| South Africa | Sanofi-Aventis Investigational Site Number 710001 | Cape Town | |
| South Africa | Sanofi-Aventis Investigational Site Number 710003 | Cape Town | |
| South Africa | Sanofi-Aventis Investigational Site Number 710007 | Durban | |
| South Africa | Sanofi-Aventis Investigational Site Number 710009 | Durban | |
| South Africa | Sanofi-Aventis Investigational Site Number 710006 | Port Elizabeth | |
| South Africa | Sanofi-Aventis Investigational Site Number 710005 | Pretoria | |
| Spain | Sanofi-Aventis Investigational Site Number 724006 | Badalona | |
| Spain | Sanofi-Aventis Investigational Site Number 724001 | Barcelona | |
| Spain | Sanofi-Aventis Investigational Site Number 724002 | Barcelona | |
| Spain | Sanofi-Aventis Investigational Site Number 724004 | Barcelona | |
| Spain | Sanofi-Aventis Investigational Site Number 724008 | Barcelona | |
| Spain | Sanofi-Aventis Investigational Site Number 724003 | Madrid | |
| Spain | Sanofi-Aventis Investigational Site Number 724010 | Oviedo | |
| Spain | Sanofi-Aventis Investigational Site Number 724007 | Palma De Mallorca | |
| Spain | Sanofi-Aventis Investigational Site Number 724013 | Palma De Mallorca | |
| Spain | Sanofi-Aventis Investigational Site Number 724009 | Pamplona | |
| Spain | Sanofi-Aventis Investigational Site Number 724011 | Santiago De Compostela | |
| Spain | Sanofi-Aventis Investigational Site Number 724012 | Zaragoza | |
| Sweden | Sanofi-Aventis Investigational Site Number 752001 | Umeå | |
| Sweden | Sanofi-Aventis Investigational Site Number 752002 | Uppsala | |
| Turkey | Sanofi-Aventis Investigational Site Number 792002 | Ankara | |
| Turkey | Sanofi-Aventis Investigational Site Number 792003 | Ankara | |
| Turkey | Sanofi-Aventis Investigational Site Number 792004 | Ankara | |
| Turkey | Sanofi-Aventis Investigational Site Number 792001 | Istanbul | |
| Turkey | Sanofi-Aventis Investigational Site Number 792006 | Istanbul | |
| United States | Sanofi-Aventis Investigational Site Number 840068 | Anchorage | Alaska |
| United States | Sanofi-Aventis Investigational Site Number 840060 | Athens | Georgia |
| United States | Sanofi-Aventis Investigational Site Number 840045 | Baltimore | Maryland |
| United States | Sanofi-Aventis Investigational Site Number 840035 | Berkeley | California |
| United States | Sanofi-Aventis Investigational Site Number 840020 | Bethlehem | Pennsylvania |
| United States | Sanofi-Aventis Investigational Site Number 840001 | Boca Raton | Florida |
| United States | Sanofi-Aventis Investigational Site Number 840030 | Boise | Idaho |
| United States | Sanofi-Aventis Investigational Site Number 840048 | Boynton Beach | Florida |
| United States | Sanofi-Aventis Investigational Site Number 840012 | Burbank | California |
| United States | Sanofi-Aventis Investigational Site Number 840041 | Chapel Hill | North Carolina |
| United States | Sanofi-Aventis Investigational Site Number 840052 | Charleston | South Carolina |
| United States | Sanofi-Aventis Investigational Site Number 840007 | Charlotte | North Carolina |
| United States | Sanofi-Aventis Investigational Site Number 840031 | Denver | Colorado |
| United States | Sanofi-Aventis Investigational Site Number 840006 | Detroit | Michigan |
| United States | Sanofi-Aventis Investigational Site Number 840065 | Dunmore | Pennsylvania |
| United States | Sanofi-Aventis Investigational Site Number 840039 | Goshen | Indiana |
| United States | Sanofi-Aventis Investigational Site Number 840009 | Hackensack | New Jersey |
| United States | Sanofi-Aventis Investigational Site Number 840008 | Houston | Texas |
| United States | Sanofi-Aventis Investigational Site Number 840018 | Houston | Texas |
| United States | Sanofi-Aventis Investigational Site Number 840049 | Jacksonville | Florida |
| United States | Sanofi-Aventis Investigational Site Number 840054 | Kansas City | Kansas |
| United States | Sanofi-Aventis Investigational Site Number 840002 | Knoxville | Tennessee |
| United States | Sanofi-Aventis Investigational Site Number 840029 | La Jolla | California |
| United States | Sanofi-Aventis Investigational Site Number 840044 | Lake Success | New York |
| United States | Sanofi-Aventis Investigational Site Number 840061 | Lakeland | Florida |
| United States | Sanofi-Aventis Investigational Site Number 840026 | Lansing | Michigan |
| United States | Sanofi-Aventis Investigational Site Number 840046 | Los Angeles | California |
| United States | Sanofi-Aventis Investigational Site Number 840017 | Lubbock | Texas |
| United States | Sanofi-Aventis Investigational Site Number 840011 | Madison | Wisconsin |
| United States | Sanofi-Aventis Investigational Site Number 840025 | Marshfield | Wisconsin |
| United States | Sanofi-Aventis Investigational Site Number 840024 | Maywood | Illinois |
| United States | Sanofi-Aventis Investigational Site Number 840004 | Metarie | Louisiana |
| United States | Sanofi-Aventis Investigational Site Number 840038 | Milwaukee | Wisconsin |
| United States | Sanofi-Aventis Investigational Site Number 840013 | New York | New York |
| United States | Sanofi-Aventis Investigational Site Number 840050 | New York | New York |
| United States | Sanofi-Aventis Investigational Site Number 840057 | Paducah | Kentucky |
| United States | Sanofi-Aventis Investigational Site Number 840062 | Peoria | Illinois |
| United States | Sanofi-Aventis Investigational Site Number 840056 | Rochester | New York |
| United States | Sanofi-Aventis Investigational Site Number 840003 | Sacramento | California |
| United States | Sanofi-Aventis Investigational Site Number 840016 | San Antonio | Texas |
| United States | Sanofi-Aventis Investigational Site Number 840005 | San Bernardino | California |
| United States | Sanofi-Aventis Investigational Site Number 840033 | San Diego | California |
| United States | Sanofi-Aventis Investigational Site Number 840036 | Seattle | Washington |
| United States | Sanofi-Aventis Investigational Site Number 840047 | St. Joseph | Michigan |
| United States | Sanofi-Aventis Investigational Site Number 840032 | Stamford | Connecticut |
| United States | Sanofi-Aventis Investigational Site Number 840019 | Sylvania | Ohio |
| United States | Sanofi-Aventis Investigational Site Number 840015 | Syracuse | New York |
| United States | Sanofi-Aventis Investigational Site Number 840064 | Temple | Texas |
| United States | Sanofi-Aventis Investigational Site Number 840021 | Washington | District of Columbia |
| United States | Sanofi-Aventis Investigational Site Number 840034 | Washington | District of Columbia |
| United States | Sanofi-Aventis Investigational Site Number 840010 | Woodlands | Texas |
| United States | Sanofi-Aventis Investigational Site Number 840058 | Woonsocket | Rhode Island |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi |
United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, France, India, Israel, Italy, Mexico, Netherlands, Poland, Russian Federation, South Africa, Spain, Sweden, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall survival defined as the time interval from the date of randomization to the date of death due to any cause | study period | No | |
| Secondary | Radiological tumor assessments (CT/MRI) | at screening, every 8 weeks during treatment, at end of treatment, and in follow-up until documented disease progression | No | |
| Secondary | Adverse Events, laboratory assessments, vital signs, Physical Examinations, and ECOG Performance Status | at screening and every cycle | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02612194 -
LCI-GU-URO-CRI-001: Crizotinib in Patients With c-MET or RON-Positive Metastatic Urothelial Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT02805608 -
uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT02534623 -
Postoperative Quality of Recovery After Transurethral Resection of the Bladder
|
N/A | |
| Recruiting |
NCT02228473 -
Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort
|
N/A | |
| Completed |
NCT02778243 -
Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level
|
N/A | |
| Recruiting |
NCT05007106 -
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
|
Phase 2 | |
| Completed |
NCT01688999 -
Cabozantinib for Advanced Urothelial Cancer
|
Phase 2 | |
| Completed |
NCT03219333 -
A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
|
Phase 2 | |
| Recruiting |
NCT05068180 -
Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients
|
Phase 4 | |
| Terminated |
NCT02560038 -
Trial of Paclitaxel Plus Gemcitabine and Cisplatin in Bladder Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT02252445 -
Propofol and Sevoflurane for Catheter-Related Bladder Discomfort
|
N/A | |
| Not yet recruiting |
NCT02760953 -
TURBt With Adjuvant Cryoablation to Treat Bladder Cancer
|
N/A | |
| Terminated |
NCT04430036 -
AGEN1884 Plus AGEN2034 Combined With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT06289283 -
Microbiota in Urine and Urothelium Can be a Factor for Induction of Urinary Bladder Cancer. The Study Will Examine Urine and Bladder Cancer Tissues From Male Patients and Urine of Controls Using Whole Genomic Sequencing Techniques and 16S rRNA. The Aim is to Elucidate Role of Microbiota in Bladder
|
||
| Active, not recruiting |
NCT03288545 -
A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03661320 -
A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer
|
Phase 3 | |
| Completed |
NCT01478685 -
A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or Refractory Solid Tumors
|
Phase 1 | |
| Completed |
NCT03404791 -
A Study of TAR-200 in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Ineligible for or Refuse Cisplatin-based Chemotherapy and Who Are Unfit for Radical Cystectomy
|
Phase 1 | |
| Terminated |
NCT01479348 -
Imaging Study for FdCyd and THU Cancer Treatment
|
Early Phase 1 | |
| Recruiting |
NCT05742867 -
A Study to Evaluate Treatment Preferences for Japanese Participants With Muscle-invasive Urothelial Carcinoma of the Bladder
|