A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

1,886

Participants

Timeline

Start Date

April 18, 2003

Primary Completion Date

April 21, 2011

Study Completion Date

April 21, 2011

Conditions
Colorectal Cancer
Interventions
DRUG

Capecitabine

1000 milligrams per square metre of body surface area (mg/m\^2) orally twice daily on days 1-15 of each 3-week cycle.

DRUG

Oxaliplatin

130 mg/m\^2 intravenous (IV) infusion over two hours on Day 1 of each 3-week cycle.

DRUG

Leucovorin (LV)

Administered by one of two regimens, as specified in the arm description.

DRUG

5-Fluorouracil (5-FU)

Administered by one of two regimens, as specified in the arm description.

Trial Locations (232)

8

St. James Hospital; Oncology, Dublin

333

Chang Gung Medical Foundation - Linkou; Colo-rectal Surgery, Taoyuan District

852

Queen Mary Hospital; Surgery, Hong Kong

1023

Auckland city hospital; Auckland Regional Cancer Centre and Blood Service, Auckland

1051

Ogyi, Orszagos Gyogyszereszeti Intezet, Budapest

1097

Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X, Budapest

1122

Orszagos Onkologial Intezet; Onkologiai Osztaly X, Budapest

1200

Cliniques Universitaires St-Luc, Brussels

2050

Royal Prince Alfred Hospital; Medical Oncology, Camperdown

2196

Sandton Oncology Medical Group, Sandton

2444

Port Macquarie Base Hospital; Oncology, Port Macquarie

2500

Southern Medical Day Care; Clinical Trials Unit, Wollongong

3000

UZ Leuven Gasthuisberg, Leuven

3011

Footscray Hospital, Footscray

3128

Box Hill Hospital; Oncology, Box Hill

3201

Hopelands Cancer Centre ST. ANNES HOSPITAL; DEPT. OF ONCOLOGY, Pietermaritzburg

4001

Hopelands Cancer Centre; Oncology, Durban

4031

Universitaetsspital Basel; Onkologie, Basel

4442

Palmerston North Hospital; Regional Cancer Treatment Service, Palmerston North

5011

Queen Elizabeth Hospital; Medical Oncology, Woodville South

6000

GHdC Site Notre Dame, Charleroi

6002

Wellington Hospital; Regional Oncology Unit, Wellington

6008

St John of God Hospital; Medical Oncology, Perth

6720

Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika, Szeged

7500

Panorama Medical Clinic; Oncology Unit, Cape Town

8500

AZ Groeninge, Kortrijk

9000

UZ Gent, Ghent

9016

Dunedin Hospital; Oncology - Haematology Clinical Practice Group, Dunedin

10011

St. Vincent'S Hospital; Comprehensive Care Center, New York

10110

Bumrungrad Hospital Foundation; Horizon Centre, Bangkok

10400

Pramongkutklao Hospital; Medicine - Medical Oncology Unit, Bangkok

Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc, Bangkok

10676

Evangelismos Hospital; Medical Oncology, Athens

10700

Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology, Bangkok

11259

Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology, Taipei

11527

Per. Gen. Hospital Ippokrateion; Oncology Dept., Athens

13273

Institut Paoli Calmettes; Oncologie Medicale, Marseille

14000

Instituto Nacional De Ciencias Medicas Y Nutricion; Nefrology, Mexico City

14004

Hospital Universitario Reina Sofia; Servicio de Oncologia, Córdoba

15232

Uni of Pittsburgh Cancer Inst. ; Oncology, Pittsburgh

16132

Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical, Genoa

18015

Oncology-Hematology of Lehigh Valley, Pc, Bethlehem

18704

Medical Oncology Associates, Kingston

19111

Fox Chase-Temple Cancer Center, Philadelphia

20007

Georgetown Uni Medical Center; Lombardi Cancer Center, Washington D.C.

20141

Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica, Milan

20520

Turku Uni Central Hospital; Oncology Clinics, Turku

21100

Clinica de Especialidades # 30 Dr. Humberto Torres Sangines; Oncology, Mexicali

22100

Nahariya Hospital; Oncology, Nahariya

23007

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia, Jaén

24127

Asst Papa Giovanni XXIII; Oncologia Medica, Bergamo

27403

Moses Cone Reg Cancer Ctr, Greensboro

28006

Hospital Universitario de la Princesa; Servicio de Oncologia, Madrid

28007

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid

28040

Hospital Universitario Clínico San Carlos; Servicio de Oncologia, Madrid

28041

Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid

28046

Hospital Universitario La Paz; Servicio de Oncologia, Madrid

28222

Hospital Universitario Puerta de Hierro; Servicio de Oncologia, Majadahonda

28602

Carolina Oncology Specialists, PA - Hickory, Hickory

28911

Hospital Severo Ochoa; Servicio de Oncologia, Leganés

29010

Hospital Regional Universitario Carlos Haya; Servicio de Oncologia, Málaga

30341

Georgia Cancer Specialists, Atlanta

31000

Centro Estatal de Cancerología, Chihuahua City

Hospital Christus Muguerza Del Parque; Centro de Rehabilitacion, Chihuahua City

33100

Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia, Udine

33136

Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center, Miami

33520

Tampere University Hospital; Dept of Oncology, Tampere

36608

The Cancer Center At Providence Park, Mobile

38138

West Clinic, Germantown

39008

Hospital Universitario Marques de Valdecilla; Servicio de Oncologia, Santander

39130

Klinikum Magdeburg gemeinnützige GmbH; Klinik Haematologie und Onkologie, Magdeburg

40002

Srinagarind Hospital; Medical Oncology Unit, Khon Kaen

43100

Ospedale Regionale Di Parma; Divisione Di Oncologia Medica, Parma

46009

Instituto Valenciano Oncologia; Oncologia Medica, Valencia

46010

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia

46026

Hospital Universitario la Fe; Servicio de Oncologia, Valencia

47802

Hope Center, Terre Haute

47841

Ospedale Cervesi di Cattolica; ONCOLOGIA, Cattolica

47900

Ospedale Degli Infermi; Divisione Di Oncologia, Rimini

48903

Hospital de Cruces; Servicio de Oncologia, Bilbao

53036

Azienda Usl 7; Dept. Oncologico, Poggibonsi

53792

UNI OF WISCONSIN SCHOOL OF MEDICINE; GI Oncology Research Group, Paul P Carbone Cancer Center, Madison

54290

Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie, Trier

55416

Park Nicollet Clinic Cancer Center, Saint Louis Park

56439

Theageneio Anticancer Hospital; Gastroenterology, Thessaloniki

57100

Ospedale Civile; Unita Operativa Di Oncologia Medica, Livorno

59037

Hopital Claude Huriez; Medecine Interne Oncologie, Lille

59101

Hematology-Oncology Centers of the Northern Rockies, Billings

59405

Great Falls Clinic, Great Falls

60121

A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica, Ancona

61615

Illinois Cancer Care, Peoria

63136

Hematology Oncology Consultants, Inc., St Louis

64507

St Joseph Oncology, Saint Joseph

67091

Hopital Civil; Hematologie Oncologie, Strasbourg

68024

Hopital Louis Pasteur; Medecine B, Colmar

70121

Ochsner Cancer Inst., New Orleans

77380

US Oncology, The Woodlands

79110

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR, Freiburg im Breisgau

80045

University of Colorado Health Science Center; Biomedical Research Bldg. Room 511, Aurora

80528

Hematology Oncology Associates, Fort Collins

84106

Intermountain Hematology & Oncology, Salt Lake City

87109

New Mexico Oncology Hematology Consultants, Albuquerque

89502

Va Medical Center, Reno

90603

Innovative clinical research institute/American institute of research, Whittier

90813

Pacific Shores Medical Group, Long Beach

91325

West Valley Hematology Oncology The Thomas and Dorothy Leavey Cancer Center, Northridge

91767

Wilshire Oncology Medical Group, Pomona

91801

Central Hematology Oncology Medical Group Inc., Alhambra

92083

San Diego Cancer Center'S Medical Group, Vista

92121

Scripps Cancer Center, San Diego

92154

Kaiser Permanente San Diego; Hepatology Research, San Diego

92835

Virginia K. Crossen Cancer Center, Fullerton

93030

Ventura County Hematology-Oncology Specialists, Oxnard

93105

Santa Barbara Hematology Oncology Medical Group, Inc., Santa Barbara

93309

Comprehensive Blood/Cancer Ctr, Bakersfield

95816

Sutter Cancer Center, Sacramento

98902

Internal Medicine Associates of Yakima Inc., Yakima

100021

Cancer Hospital Chinese Academy of Medical Sciences., Beijing

105229

N.N.Burdenko Main Military Clinical Hospital; Chemotherapy, Moscow

115478

Blokhin Cancer Research Center; Combined Treatment, Moscow

119228

National University Hospital; National University Cancer Institute, Singapore (NCIS), Singapore

169610

National Cancer Centre; Medical Oncology, Singapore

197758

Petrov Research Inst. of Oncology; Dept of Bio-Therapy & Transplantation of Bone Marrow, Saint Petersburg

198255

St. Petersburg City Clinical Oncological Dispensary; Colorectal (Department 4), Saint Petersburg

200025

Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital), Shanghai

200092

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

200120

Fudan University Shanghai Cancer Center, Shanghai

210009

Jiangsu Cancer Hospital, Nanjing

250117

Shandong Cancer Hospital; Oncology, Shandong

300060

Tianjin Cancer Hospital, Tianjin

310009

The Second Affiliated Hospital of Zhejiang University College, Hangzhou

330006

The 1st Affiliated Hospital of Nanchang Unversity, Nanchang

430030

Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech, Wuhan

510515

Nanfang Hospital, Southern Medical University, Guangzhou

3109601

Rambam Medical Center; Oncology, Haifa

4428164

Meir Medical Center; Oncology, Kfar Saba

4941492

Rabin Medical Center; Oncology Dept, Petah Tikva

6093000

Assaf Harofeh; Oncology, Ẕerifin

7610001

Kaplan Medical Center; Oncology Inst., Rehovot

8410100

Soroka Medical Center; Oncology Dept, Beersheba

9103102

Shaare Zedek Medical Center; Oncology Dept, Jerusalem

9112000

Hadassah Ein Karem Hospital; Oncology Dept, Jerusalem

06902

Hematology Oncology P.C., Stamford

33804-1057

Lakeland Regional Cancer Center, Lakeland

03106

Nh Oncology Hematology, Pa, Hooksett

07962

Morristown Medical Center;Hematology-Oncology Assoc, Morristown

07901

Overlook Oncology Center; Summit Medical Group, Summit

28233-3549

Presbyterian Healthcare; Cancer Research Dept, Charlotte

19104-4283

Hospital of the Uni of Pennsylvania; Section of Hematology/Oncology, Philadelphia

30285-000

Hospital de Baleia; Serviço de Oncologia Clínica, Belo Horizonte

17210-120

Hospital Amaral Carvalho, Jaú

05403-000

Hospital das Clinicas - FMUSP; Gastroenterologia, São Paulo

T2N 4N2

Tom Baker Cancer Centre; Dept of Medicine, Calgary

T6G 1Z2

Cross Cancer Institute ; Dept of Medical Oncology, Edmonton

V1Y 5L3

Bcca - Cancer Center Southern Interior, Kelowna

V3V 1Z2

Bcca-Fraser Valley Cancer Centre, Surrey

V8R 6V5

Bcca - Vancouver Island Cancer Centre; Oncology, Victoria

R2H 2A6

St. Boniface General Hospital, Winnipeg

A1B 3V6

Dr. H. Bliss Murphy Cancer Centre; Oncology, St. John's

B3H 2Y9

Queen Elizabeth II Health Sciences Centre; Oncology, Halifax

L8V 5C2

Hamilton Health Sciences - Juravinski Cancer Centre, Hamilton

N6A 4L6

London Regional Cancer Centre, London

L5M 2N1

Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre, Mississauga

L1G 2B9

Lakeridge Health Oshawa; Oncology, Oshawa

K1H 8L6

The Ottawa Hospital Cancer Centre; Oncology, Ottawa

M3M 0B2

Humber River Hospital, Toronto

M4N 3M5

Sunnybrook Health Science Centre, Toronto

M5G 2M9

University Health Network; Princess Margaret Hospital; Medical Oncology Dept, Toronto

H7M 3L9

Cite de La Sante de Laval; Hemato-Oncologie, Laval

G6V 3Z1

Hotel Dieu de Levis; Oncology, Lévis

H1T 2M4

Hopital Maisonneuve- Rosemont; Oncology, Montreal

H2X 0A9

Chum Campus Notre Dame, Montreal

H3T 1E2

McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology, Montreal

H4J 1C5

Hopital Du Sacre Coeur de Montreal; Pneumologie, Montreal

G1R 2J6

Chuq - Hopital Hotel Dieu de Quebec; Oncology, Québec

06120

Universitaetsklinikum Halle; Klinik u.Poliklinik fuer Innere Medizin IV, Halle

711 10

Univ General Hosp Heraklion; Medical Oncology, Heraklion

265 04

University Hospital of Patras Medical Oncology, Pátrai

546 39

Theagenio Anticancer Hospital; 3Rd Oncology Clinic, Thessaloniki

Unknown

Mercy Uni Hospital; Deparment of Medical Oncology, Cork

Galway Uni Hospital; Oncology Dept, Galway

Golda Hasharon Medical Center; Oncology, Petah Tikva

Christchurch Hospital; Dept of Oncology, Christchurch

Isthmian Medical Research Center, S.A.; Oncology, Panama City

Mackay Memorial Hospital; Department of Surgery, Division of Colon and Rectal Surgery, Taipei

52620-00

Chaim Sheba Medical Center; Oncology Dept, Ramat Gan

64239-06

Sourasky / Ichilov Hospital; Oncology Department, Tel Aviv

07100

Ospedale Civile; Oncologia Medica, Sassari

31-826

Rydygiera Hospital; Chemotherapy, Krakow

93-509

Wojewodzki Szpital Specjalistyczny Im. M. Kopernika; Oddzial Chorob Rozrostowych, Lodz

61-866

Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii, Poznan

71-730

Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych, Szczecin

02-781

Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Klinika Nowotworow Jelita Grubego, Warsaw

65-046

Lubuski Osrodek Onkologii, Szpital Wojewodzki; Oddzial Onkologii, Zielona Góra

7801-849

Hospital Jose Joaquim Fernandes; Unidade de Oncologia Medica, Beja

1649-035

Hospital de Santa Maria; Servico de Oncologia Medica, Lisbon

4200-072

IPO do Porto; Servico de Oncologia Medica, Porto

0001

Little Company of Mary Hospital; Mary Potter Oncology Centre, Pretoria

03080

Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology, Seoul

03722

Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology, Seoul

133-792

Hanyang Uni Hospital; Dept. of Internal Medicine , Section of Hemato-Oncology, Seoul

135-710

Samsung Medical Centre; Division of Hematology/Oncology, Seoul

138-736

Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology, Seoul

03203

Hospital General Universitario de Elche; Servicio de Oncologia, Elche

07014

Hospital Universitario Son Espases, Palma de Mallorca

08035

Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona

08036

Hospital Clínic i Provincial; Servicio de Hematología y Oncología, Barcelona

08907

Hospital Duran i Reynals; Oncologia, Barcelona

AB25 2ZN

Aberdeen Royal Infirmary; Medical Oncology Dept, Aberdeen

BN2 5BE

The Royal Sussex County Hospital; the Sussex Cancer Centre, Brighton

IP33 2QZ

West Suffolk Hospital Nhs Trust; Gi Corridor, Bury St Edmunds

CB2 2QH

Addenbrooke'S Hospital; Univ.Dept.& Mrc Unit of Clin.Oncology & Radiotherapeutics, Cambridge

DE1 2QY

Derbyshire Royal Infirmary; Dept of Oncology, Derby

G12 0YN

Cruk Clinical Trials Unit; Level 0 Beatson West Of Scotland Cancer Ctr, Glasgow

GU2 7XX

Royal Surrey County Hospital; St. Lukes Cancer Centre, Guildford

LS9 7TF

St James Institute of Oncology, Leeds

LE1 5WW

Leicester Royal Infirmary; Dept. of Medical Oncology, Leicester

SE1 7EH

St Thomas Hospital; Oncology Dept, London

SW3 6JJ

Royal Marsden Nhs Trust; Consultant Cancer Physician, London

W12 OHS

Hammersmith Hospital; Mrc Clinical Science Centre, London

W6 8RF

Charing Cross Hospital; Medical Oncology., London

ME16 9QQ

Maidstone Hospital, Maidstone

M20 4QL

Christie Hospital; Breast Cancer Research Office, Manchester

TS4 3BW

James Cook Uni Hospital, Middlesbrough

NE7 7DN

Northern Centre for Cancer Care;Oncology, Newcastle upon Tyne

HA6 2RN

Mount Vernon Hospital; Centre For Cancer Treatment, Northwood

NG5 1PB

Nottingham City Hospital; Oncology, Nottingham

PL6 8DH

Derriford Hospital; Plymouth Oncology Centre, Plymouth

LL18 5UJ

North Wales Cancer Treatment Centre, Glan Clwyd Hospital, Rhyl

SP2 8BJ

Salisbury District General Hospital; Medical Oncology Dept, Salisbury

SO16 6YD

Southampton General Hospital; Somers Cancer Research Building, Southampton

SM2 5PT

Royal Marsden Hospital; Dept of Medical Oncology, Sutton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT00069121 - A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer | Biotech Hunter | Biotech Hunter