A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

2,035

Participants

Timeline

Start Date

July 31, 2003

Primary Completion Date

January 31, 2006

Study Completion Date

April 30, 2009

Conditions
Colorectal Cancer
Interventions
DRUG

Oxaliplatin 130 mg/m^2

Oxaliplatin was administered in a 2 h infusion before the first dose of capecitabine.

DRUG

Capecitabine 1000 mg/m^2

Capecitabine was taken within 30 min after the end of breakfast and dinner.

DRUG

Bevacizumab 7.5 mg/kg

Bevacizumab was administered in a 30 to 90 min infusion.

DRUG

Placebo for bevacizumab 7.5 mg/kg

Placebo control for bevacizumab (volume equivalent to 7.5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.

DRUG

Oxaliplatin 85 mg/m^2

Oxaliplatin 85 mg/m\^2 was administered simultaneously with leucovorin in a 2 h infusion.

DRUG

Leucovorin 200 mg/m^2

Leucovorin was administered simultaneously with oxaliplatin 85 mg/m\^2 in a 2 h infusion.

DRUG

Fluorouracil 400 mg/m^2

DRUG

Bevacizumab 5 mg/kg

Bevacizumab was administered in a 30 to 90 min infusion.

DRUG

Placebo for bevacizumab 5 mg/kg

Placebo control for bevacizumab (volume equivalent to 5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.

Trial Locations (236)

4

Dublin

8

Dublin

100

Taipei

112

Taipei

114

Taipei

333

Kueishan

1082

Budapest

1090

Vienna

1205

Geneva

2031

Sydney

2050

Camperdown

2065

St Leonards

2100

Copenhagen

2139

Sydney

2199

Sandton

2444

Port Macquarie

2730

Herlev

3002

Melbourne

3010

Bern

3011

Footscray

3065

Fitzroy

3128

Box Hill

3144

Malvern

3181

Melbourne

4101

Brisbane

4600

Wels

5000

Odense

5011

Adelaide

5021

Bergen

5037

Kurralta Park

6000

Perth

Kecskemét

7506

Cape Town

9002

Győr

9038

Tromsø

10065

New York

10110

Bangkok

10700

Bangkok

13210

Syracuse

14000

Mexico City

14004

Córdoba

14623

Rochester

16132

Genova

17176

Stockholm

18014

Granada

18435

Stralsund

18840

Sayre

19013

Upland

20520

Turku

21079

Dijon

23294

Richmond

25030

Besançon

27100

Pavia

28007

Madrid

28034

Madrid

28040

Madrid

28041

Madrid

28046

Madrid

28203

Charlotte

28911

Leganés

29010

Málaga

29209

Columbia

29425

Charleston

29609

Brest

30029

Nîmes

30341

Atlanta

30625

Hanover

31052

Toulouse

31096

Haifa

32207

Jacksonville

33486

Boca Raton

33520

Tampere

33607

Tampa

33647

Tampa

34300

Istanbul

34652

New Port Richey

35100

Padua

Izmir

37171

Chambray-lès-Tours

38100

Grenoble

38120

Memphis

39008

Santander

40002

Khon Kaen

41100

Modena

42100

Reggio Emilia

43100

Parma

44093

Saint-Herblain

44625

Herne

44805

Saint-Herblain

44892

Bochum

46009

Valencia

46010

Valencia

46026

Valencia

48106

Ann Arbor

49100

Petah Tikva

50009

Zaragoza

54290

Trier

55131

Mainz

55416

Saint Louis Park

57072

Metz

58122

Fargo

58501

Bismarck

60007

Elk Grove Village

60121

Ancona

60640

Chicago

64239

Tel Aviv

65185

Karlstad

68024

Colmar

68167

Mannheim

69373

Lyon

69495

Pierre-Bénite

70121

New Orleans

70300

Ẕerifin

72189

Västerås

75475

Paris

75651

Paris

75679

Paris

76031

Rouen

77024

Houston

80187

Gävle

87401

Farmington

89106

Las Vegas

90057

Los Angeles

91120

Jerusalem

92104

Boulogne-Billancourt

92123

San Diego

92708

Fountain Valley

92835

Fullerton

92868

Orange

93009

Bobigny

93053

Regensburg

94304

Palo Alto

94704

Berkeley

94904

Greenbrae

95020

Gilroy

100021

Beijing

100853

Beijing

105229

Moscow

115478

Moscow

117837

Moscow

197758

Saint Petersburg

198255

Saint Petersburg

200025

Shanghai

200092

Shanghai

210009

Jiangsu

250117

Shandong

300060

Tianjin

330000

Jiangxi

430030

Wuhan

510060

Guangzhou

510515

Guangdong

06360

Norwich

06708

Waterbury

33610-0277

Gainesville

61615-7828

Peoria

40536-0098

Lexington

04074

Scarborough

02135

Boston

07019

East Orange

08690

Hamilton

08901

New Brunswick

87131-0001

Albuquerque

28233-3549

Charlotte

02906

Providence

05401

Burlington

17210-080

Jaú

20231-050

Rio de Janeiro

05403-000

São Paulo

T2N 4N2

Calgary

T6G 1Z2

Edmonton

V1Y 5L3

Kelowna

V7L 2L7

North Vancouver

V3V 1Z2

Surrey

V5Z 1H5

Vancouver

V8R 6V5

Victoria

R2H 2A6

Winnipeg

B3H 1V7

Halifax

L8V 5C2

Hamilton

N6A 4L6

London

L5M 2N1

Mississauga

L1G 2B9

Oshawa

K1H 8L6

Ottawa

L2R 7C6

St. Catharines

M4N 3M5

Toronto

M5G 1X5

Toronto

M5G 2M9

Toronto

M9N 1N8

Toronto

G6V 3Z1

Lévis

H1T 2M4

Montreal

H2L 4M1

Montreal

H4J 1C5

Montreal

G1R 2J6

Québec

656 53

Brno

430 12

Chomutov

500 36

Hradec Králové

708 52

Ostrava

00029

Helsinki

06189

Nice

06202

Nice

06120

Halle

04129

Leipzig

01009

Guatemala City

01015

Guatemala City

Unknown

Hong Kong

Cork

Galway

Christchurch

Panama City

H-1122

Budapest

07100

Sassari

0407

Oslo

7801-849

Beja

1649-035

Lisbon

00907

San Juan

0001

Pretoria

135-170

Seoul

08035

Barcelona

08036

Barcelona

751 85

Uppsala

AB25 2ZN

Aberdeen

B18 7QH

Birmingham

CF14 2TL

Cardiff

DE1 2QY

Derby

G12 0YN

Glasgow

GU2 7XX

Guildford

HU8 9HE

Hull

SW3 6JJ

London

ME16 9QQ

Maidstone

NE7 7DN

Newcastle upon Tyne

HA6 2RN

Northwood

NG5 1PB

Nottingham

PL6 8DH

Plymouth

SP2 8BJ

Salisbury

SO9 4PE

Southampton

SM2 5PT

Sutton

TA1 5DA

Taunton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT00069095 - A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer | Biotech Hunter | Biotech Hunter