AzTrials
AzTrials

Bladder CancerPhase 3NCT00022191

Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer

A Phase 3 study testing cisplatin, gemcitabine hydrochloride and paclitaxel in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by European Organisation for Research and Treatment of Cancer - EORTC at 234 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for urinary tract cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cisplatin, gemcitabine hydrochloride and paclitaxel
How many people
608 participants
Where
234 sitesin 16 countries
Study dates
May 2001to Jun 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IV transitional cell carcinoma of the urothelium (pure or mixed) including bladder, urethra, ureter, and renal pelvis
  • T4b, any N OR any T, N2-3 OR M1
  • Ineligible for surgery or radiotherapy with curative intent
  • Measurable or evaluable disease
  • No known CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • WHO 0-1

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic:

  • Bilirubin less than 1.25 times normal
  • AST or ALT less than 2.5 times normal

Renal:

  • Glomerular filtration rate at least 60 mL/min
  • Calcium normal or clinically insignificant

Cardiovascular:

  • No clinically significant cardiac arrhythmia
  • No congestive heart failure
  • No complete bundle branch block
  • No New York Heart Association class III or IV heart disease

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study participation
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance
  • No grade 3 or 4 infection without neutropenia
  • No other serious concurrent systemic disorder that would preclude study therapy
  • No mental disorder that would preclude study compliance
  • No grade II or greater neuropathy
  • No other prior or concurrent malignancy except appropriately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or incidental prostate cancer (T1, Gleason score no greater than 6, and PSA less than 0.5 ng/mL)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior investigational biologic agents (e.g., antiangiogenic products, signal transduction pathway inhibitors, immunomodulators, or monoclonal antibody therapy)
  • At least 4 weeks since prior immunotherapy

Chemotherapy:

  • No prior systemic chemotherapy
  • At least 4 weeks since prior local intravesical chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • No more than 1 prior course of radiotherapy
  • At least 4 weeks since prior radiotherapy and recovered

Surgery:

  • See Disease Characteristics
  • Prior urological procedures to relieve urinary tract obstruction and improve renal function allowed (e.g., ureteral stent or percutaneous nephrostomy)

Trial locations and contacts

234 sites in 16 countries.

234 sites in 16 countries

Canada69 sites

  • Royal Victoria Hospital, Barrie

    Barrie, Ontario, L4M 6M2

  • William Osler Health Centre

    Brampton, Ontario, L6W 2Z8

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Prince Edward Island Cancer Center at Queen Elizabeth Hospital

    Charlottetown, Prince Edward Island, C1A 8T5

  • Complexe Hospitalier de la Sagamie

    Chicoutimi, Quebec, G7H 5H6

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • CHUS-Hopital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • Northeastern Ontario Regional Cancer Centre - Sudbury

    Greater Sudbury, Ontario, P3E 5J1

  • Hopital Charles Lemoyne

    Greenfield Park, Quebec, J4V 2H1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Hamilton and District Urology Association

    Hamilton, Ontario, L8N 1T8

  • Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Centre Hospitalier Regional de Lanaudiere

    Joliette, Quebec, J6E 6J2

  • British Columbia Cancer Agency - Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Kingston Regional Cancer Centre

    Kingston, Ontario, K7L 5P9

  • Grand River Regional Cancer Centre

    Kitchner, Ontario, N2G 1G3

  • Lethbridge Cancer Clinic

    Lethbridge, Alberta, T1J 1W5

  • Hotel-Dieu de Levis

    Lévis, Quebec, G6V 3Z1

  • London Health Sciences Centre

    London, Ontario, N6A 4G5

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Markham Stouffville Hospital

    Markham, Ontario, L6B IAI

  • Trillium Health Centre

    Mississauga, Ontario, L5B 1B8

  • Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

  • Moncton Hospital

    Moncton, New Brunswick, E1C 6ZB

  • Doctor Leon Richard Oncology Centre

    Moncton, New Brunswick, E1C 8X3

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2L-4M1

  • McGill University

    Montreal, Quebec, H2W 1S6

  • Hotel Dieu de Montreal

    Montreal, Quebec, H2W 1T8

  • Hopital Sainte Justine

    Montreal, Quebec, H3T 1C5

  • Hopital Du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • Nanaimo Cancer Clinic at Nanaimo Regional General Hospital

    Nanaimo, British Columbia, V9S 2B7

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9

  • Lions Gate Hospital

    North Vancouver, British Columbia, V7L 2P9

  • North York General Hospital, Ontario

    North York, Ontario, M2K 1E1

  • Sunnybrook and Women's College Health Sciences Centre

    North York, Ontario, M4N 3M5

  • Male Health Centre - Oakville

    Oakville, Ontario, L6H 3PI

  • Durham Regional Cancer Centre at Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario, K1H 1C4

  • Peterborough Oncology Clinic

    Peterborough, Ontario, K9H 7B6

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, G1R 2J6

  • Centre Hospitalier Regional de Rimouski

    Québec, Quebec, G1S 4L8

  • Hopital du Saint-Sacrement, Quebec

    Québec, Quebec, G1S 4L8

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Algoma Reginal Cancer Program at Sault Area Hospital

    Sault Ste. Marie, Ontario, P6B 1Y5

  • Scarborough Hospital - General Site

    Scarborough Village, Ontario, M1P 2V5

  • Hotel Dieu Health Sciences Hospital - Niagara

    St. Catharines, Ontario, L2R 5K3

  • Newfoundland Cancer Treatment and Research Foundation

    St. John's, Newfoundland and Labrador, A1B 3V6

  • L'Hopital Laval

    Ste-Foy, Quebec, G1V 4G5

  • Cape Breton Cancer Centre

    Sydney, Nova Scotia, B1P 1P3

  • Northwestern Ontario Regional Cancer Care

    Thunder Bay, Ontario, P7B 6V4

  • Toronto East General Hospital

    Toronto, Ontario, M4C 3E7

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital - Toronto

    Toronto, Ontario, M5B 1W8

  • Mount Sinai Hospital - Toronto

    Toronto, Ontario, M5G 1X5

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Male Health Centre - North York

    Toronto, Ontario, M6A 3B5

  • St. Joseph's Health Centre - Toronto

    Toronto, Ontario, M6R 1B5

  • Prostate Centre at Vancouver General Hospital

    Vancouver, British Columbia, V5Z 3J5

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

  • Providence Health Care - Vancouver

    Vancouver, British Columbia, V6Z 1Y6

  • British Columbia Cancer Agency - Vancouver Island Cancer Centre

    Victoria, British Columbia, V8R 6V5

  • G. Steinhoff Clinical Research

    Victoria, British Columbia, V8V 3N1

  • Humber River Regional Hospital - Weston

    Weston, Ontario, M9N 1N8

  • Cancer Care Ontario - Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

United States58 sites

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • Veterans Affairs Medical Center - Amarillo

    Amarillo, Texas, 79106

  • Veterans Affairs Medical Center - Ann Arbor

    Ann Arbor, Michigan, 48105

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0330

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center

    Aurora, Colorado, 80010

  • Veterans Affairs Medical Center - Biloxi

    Biloxi, Mississippi, 39531-2410

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • Veterans Affairs Medical Center - Charleston

    Charleston, South Carolina, 29401-5799

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Veterans Affairs Medical Center - Cincinnati

    Cincinnati, Ohio, 45220-2288

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267-0501

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195-9001

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Del Rio, Texas, 78840

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • St. Mary's - Duluth Clinic Cancer Center

    Duluth, Minnesota, 55805

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234-6200

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

    Hines, Illinois, 60141

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4095

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Veterans Affairs Medical Center - Jackson

    Jackson, Mississippi, 39216

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7390

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Missouri, 64128

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Veterans Affairs Medical Center - Lexington

    Lexington, Kentucky, 40502-2236

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0084

  • Veterans Affairs Medical Center - Little Rock (McClellan)

    Little Rock, Arkansas, 72205

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • Southwest Cancer and Research Center at University Medical Center

    Lubbock, Texas, 79415-3364

  • Veterans Affairs Outpatient Clinic - Martinez

    Martinez, California, 94553

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153-5500

  • University of Tennessee Cancer Institute

    Memphis, Tennessee, 38103

  • Veterans Affairs Medical Center - Memphis

    Memphis, Tennessee, 38104

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Veterans Affairs Medical Center - New Orleans

    New Orleans, Louisiana, 70112

  • Herbert Irving Comprehensive Cancer Center at Columbia University

    New York, New York, 10032

  • Oklahoma University Medical Center at University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Veterans Affairs Medical Center - Oklahoma City

    Oklahoma City, Oklahoma, 73104

  • Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

    Orange, California, 92868

  • Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97201-3098

  • Veterans Affairs Medical Center - Portland

    Portland, Oregon, 97207

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112-5550

  • Veterans Affairs Medical Center - Salt Lake City

    Salt Lake City, Utah, 84148

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas, 78229

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98104

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington, 98108

  • Louisiana State University Health Sciences Center - Shreveport

    Shreveport, Louisiana, 71130-3932

  • Veterans Affairs Medical Center - Shreveport

    Shreveport, Louisiana, 71130

  • Providence Cancer Institute at Providence Hospital

    Southfield, Michigan, 48075

  • St. Louis University Hospital Cancer Center

    St Louis, Missouri, 63110

  • Veterans Affairs Medical Center - Tucson

    Tucson, Arizona, 85723

  • Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, 85724

Other trials in United States

Germany34 sites

  • Krankenhaus Hohe Warte Mediziniche Klinik

    Bayreuth, 95445

  • Charite Humboldt - University Berlin

    Berlin, D-10117

  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, D-12200

  • Helios - Klinik Blankenhain

    Blankenhain, 99444

  • Universitaetsklinikum Bonn

    Bonn, D-53105

  • Staedtische Kliniken Dortmund

    Dortmund, 44143

  • Universitaetsklinik Duesseldorf

    Düsseldorf, D-40225

  • St. Markus Krankenhaus

    Frankfurt, 60431

  • Klinikum der J.W. Goethe Universitaet

    Frankfurt, D-60590

  • Klinikum Fulda

    Fulda, D-36013

  • Martin Luther Universitaet

    Halle, D-06097

  • Marienkrankenhaus

    Hamburg, 22087

  • Universitat des Saarlandes Innere Medizin 1

    Hamburg, D-66421

  • Klinikum der Friedrich-Schiller Universitaet Jena

    Jena, D-07740

  • Staedtisches Krankenhaus Sued

    Lübeck, 23560

  • Medizinische Universitaet Luebeck

    Lübeck, D-23538

  • Kreiskrankenhaus Luedenscheid

    Lüdenscheid, 58515

  • Klinikum der Stadt Ludwigshafen am Rhein

    Ludwigshafen am Rhein, D-67063

  • Klinikum der Stadt Mannheim

    Mannheim, D-68135

  • University of Marburg

    Marburg, D-35033

  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen

    Munich, D-81675

  • Klinik und Poliklinik fuer Kinderheilkunde

    Münster, D-48129

  • Klinikum Neubrandenburg

    Neubrandenburg, 17036

  • Klinikum Nuernberg - Klinikum Nord

    Nuremberg, D-90419

  • Paracelsus Karankenhaus Ruit

    Ostfildern, 73760

  • Asklepios Klinik Pasewalk

    Pasewalk, 17309

  • Diakonie - Krankenhaus

    Rotenburg (Wümme), DOH-27356

  • Johanniter Kankenhaus Stendal

    Stendal, 39576

  • Katharinenhospital

    Stuttgart, D-70174

  • Universitaetsklinikum Tuebingen

    Tübingen, D-72076

  • Universitaet Ulm

    Ulm, D-89075

  • Klinikum der Stadt Wolfsburg

    Wolfsburg, D-38440

  • Klinikum St. Marien

    Wuppertal, D-42283

  • Witten University - Klinikum Wuppertal

    Wuppertal, D-42283

Other trials in Germany

France24 sites

  • Centre Paul Papin

    Angers, 49036

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Hospitalier Docteur Duchenne

    Boulogne-sur-Mer, 62200

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Hospitalier Universitaire Henri Mondor

    Créteil, 94010

  • Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

    Dijon, 21079

  • CHU de Grenoble - Hopital de la Tronche

    Grenoble, 38043

  • Centre Hospitalier Departemental

    La Roche-sur-Yon, F-85025

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Leon Berard

    Lyon, 69373

  • CHU de la Timone

    Marseille, 13385

  • Hopital Lapeyronie-CHU Montpellier

    Montpellier, 34295

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

  • Centre Regional Rene Gauducheau

    Nantes-Saint Herblain, 44805

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Institut Curie - Section Medicale

    Paris, 75248

  • Hopital Tenon

    Paris, 75970

  • Centre Eugene Marquis

    Rennes, 35042

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Rene Huguenin

    Saint-Cloud, 92211

  • Centre Medico-Chirurgical Foch

    Suresnes, 92151

  • Centre Antoine Lacassagne

    Toulouse, 31052

  • Institut Claudius Regaud

    Toulouse, 31052

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Spain20 sites

  • Hospital Juan Canalejo

    A Coruña, 15006

  • Hospital Arquitecto Marcide

    A Coruña, 15405

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916

  • Hospital Del Mar

    Barcelona, 08003

  • Hospital Clinic y Provincial de Barcelona

    Barcelona, 08036

  • Hospital General Universitari Vall d'Hebron

    Barcelona, 08036

  • Hospital General Universitario De Guadalajara

    Guadalajara, 19002

  • Hospital Cuidad de Jaen

    Jaén, E-23006

  • Hospital Universitario San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Clinico Universitario - Malaga

    Málaga, 29010

  • Hospital Son Dureta

    Palma de Mallorca, 07014

  • Hospsital de Sabadell

    Sabadell, 08208

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Consorci Sanitari De Terrassa

    Terrassa, 08227

  • Instituto Valenciano De Oncologia

    Valencia, 46009

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Rio Hortega

    Valladolid, 47010

  • Hospital General De Vic

    Vic, 08500

  • Hospital Clinico Universitario

    Zaragoza, 50009

Other trials in Spain

United Kingdom8 sites

  • Velindre Cancer Center at Velinde Hospital

    Cardiff, Wales, CF14 2TL

  • Princess Royal Hospital

    Hull, England, HU8 9HE

  • St. James's University Hospital

    Leeds, England, LS9 7TF

  • Saint Bartholomew's Hospital

    London, England, EC1A 7BE

  • Guy's and St. Thomas' Hospitals NHS Trust

    London, England, SE1 9RT

  • Northern Centre for Cancer Treatment at Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

  • Royal South Hants Hospital

    Southampton, England, SO14 0YG

  • Royal Marsden Hospital - Sutton

    Sutton, England, SM2 5PT

Other trials in United Kingdom

Belgium5 sites

  • Onze Lieve Vrouw Ziekenhuis Aalst

    Aalst, B-9300

  • Institut Jules Bordet

    Brussels, 1000

  • Academisch Ziekenhuis der Vrije Universiteit Brussel

    Brussels, 1090

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • CHU Liege - Domaine Universitaire du Sart Tilman

    Liège, B-4000

Other trials in Belgium

Netherlands5 sites

  • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

    Amsterdam, 1066 CX

  • Jeroen Bosch Ziekenhuis

    NL'S Hertogenbosch, NL-5211

  • Daniel Den Hoed Cancer Center at Erasmus Medical Center

    Rotterdam, 3008 AE

  • Academisch Ziekenhuis Utrecht

    Utrecht, 3584 CX

  • University Hospital - Rotterdam Dijkzigt

    Utrecht, 3584 CX

Other trials in Netherlands

Denmark2 sites

  • Aarhus Kommunehospital

    Aarhus, DK-8000

  • Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

Israel2 sites

  • Rabin Medical Center - Beilinson Campus

    Petah Tikva, 49100

  • Assaf Harofeh Medical Center

    Tsrifin, 70300

Other trials in Israel

Italy2 sites

  • Ospedale Santa Croce

    Cuneo, 12100

  • Istituto Scientifico H.San Raffaele

    Milan, 20132

Other trials in Italy

Australia1 site

  • Fremantle Hospital

    Fremantle, Western Australia, 6160

Other trials in Australia

Austria1 site

  • Kaiser Franz Josef Hospital

    Vienna, A-1100

Other trials in Austria

Hungary1 site

  • National Institute of Oncology

    Budapest, 1125

Other trials in Hungary

Poland1 site

  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

    Warsaw, 02-781

Other trials in Poland

Slovakia1 site

  • National Cancer Institute - Bratislava

    Bratislava, 833 10

Other trials in Slovakia

About this study

Official title: Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients With Metastatic or Locally Advanced Urothelial Cancer Without Prior Systemic Therapy

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for urinary tract cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus gemcitabine with or without paclitaxel in treating patients who have stage IV urinary tract cancer.

Read the detailed description

OBJECTIVES:

  • Compare the duration of survival of patients with stage IV transitional cell carcinoma of the urothelium treated with cisplatin and gemcitabine with or without paclitaxel.
  • Compare the duration of progression-free survival, response rates, and duration of response in patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, WHO performance status (0 vs 1), and presence of metastatic disease (yes vs no). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 1 hour on day 1 or 2. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive paclitaxel IV over 1 hour on days 1 and 8 followed by cisplatin IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for at least 3 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 610 patients (305 per treatment arm) will be accrued for this study within 3.04 years.

Keywords
stage IV bladder cancer, transitional cell carcinoma of the bladder, urethral cancer associated with invasive bladder cancer, metastatic transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter
Medical subject headings
Urinary Bladder Neoplasms, Urethral Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMay 2001
  3. Primary completionJun 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
608 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00022191
Sponsor's protocol ID
EORTC-30987
Other IDs
EORTC-30987, CAN-NCIC-BL7, CECOG-EORTC-30987, GAUO-EORTC-30987, GETUG-EORTC-30987, SOGUG-EORTC-30987, SWOG-30987, NCRI-CRUK-BA11
Status last verified
Jun 2013
First submitted
10 Aug 2001
Last updated
12 Jun 2013
Results posted
No

Publications

  • Bellmunt J, von der Maase H, Mead GM, Skoneczna I, De Santis M, Daugaard G, Boehle A, Chevreau C, Paz-Ares L, Laufman LR, Winquist E, Raghavan D, Marreaud S, Collette S, Sylvester R, de Wit R. Randomized phase III study comparing paclitaxel/cisplatin/gemcitabine and gemcitabine/cisplatin in patients with locally advanced or metastatic urothelial cancer without prior systemic therapy: EORTC Intergroup Study 30987. J Clin Oncol. 2012 Apr 1;30(10):1107-13. doi: 10.1200/JCO.2011.38.6979. Epub 2012 Feb 27.

    PubMed 22370319

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin, gemcitabine hydrochloride and paclitaxel in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by European Organisation for Research and Treatment of Cancer - EORTC at 234 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 234 sites in Canada, United States, Germany, France, Spain and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00022191, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2013.

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