Study of Bevacizumab + mFOLFOX6 Versus Bevacizumab + FOLFIRI With Biomarker Stratification in Participants With Previously Untreated Metastatic Colorectal Cancer (mCRC)

PHASE2CompletedINTERVENTIONAL
Enrollment

376

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

May 31, 2015

Study Completion Date

July 31, 2015

Conditions
Colorectal Cancer
Interventions
DRUG

5-Fluorouracil

5-Fluorouracil 400 milligrams per meter-squared (mg/m\^2) by IV bolus and subsequent 2400 mg/m\^2 by IV infusion over 46 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.

DRUG

Bevacizumab

Bevacizumab 5 milligrams per kilogram (mg/kg) of body weight via IV infusion will be administered every 2 weeks until disease progression or unacceptable toxicity. If participants are discontinued from oxaliplatin or irinotecan due to unacceptable toxicity, bevacizumab may be given in 3-week cycles with capecitabine.

DRUG

Irinotecan

Irinotecan 180 mg/m\^2 via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.

DRUG

Leucovorin

Leucovorin 400 mg/m\^2 or dose deemed appropriate by Investigator via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.

DRUG

Oxaliplatin

Oxaliplatin 85 mg/m\^2 via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.

DRUG

Capecitabine

Capecitabine 850 or 1000 mg/m\^2 may be offered in the event of unacceptable toxicity to oxaliplatin or irinotecan, to be given orally twice a day on Days 1 to 14 in 3-week cycles.

Trial Locations (79)

24

Dublin

4031

Basel

5000

Aarau

6004

Lucerne

8063

Zurich

13419

Tallinn

14642

Rochester

15212

Pittsburgh

18512

Dunmore

19063

Media

19107

Philadelphia

27103

Winston-Salem

27262

High Point

27403

Greensboro

27710

Durham

27889

Washington

29414

Charleston

32256

Jacksonville

33021

Hollywood

33136

Miami

34952

Port Saint Lucie

35294

Birmingham

42791

Elizabethtown

43219

Columbus

43623

Toledo

46237

Indianapolis

46526

Goshen

47802

Terre Haute

51014

Tartu

53226

Wauwatosa

53792

Madison

59102

Billings

60153

Maywood

60435

Joliet

61615

Peoria

66205

Fairway

68506

Lincoln

73142

Oklahoma City

77090

Houston

78404

Corpus Christi

80218

Denver

83712

Boise

87106

Albuquerque

87110

Albuquerque

87401

Farmington

87505

Santa Fe

88011

Las Cruces

90033

Los Angeles

90706

Bellflower

91010

Duarte

92708

Fountain Valley

93720

Fresno

94080

South San Francisco

94115

San Francisco

94523

Pleasant Hill

94545

Hayward

94589

Vallejo

94596

Walnut Creek

94611

Oakland

95051

Santa Clara

95119

San Jose

95661

Roseville

95817

Sacramento

95825

Sacramento

72205-7199

Little Rock

06902

Stamford

06611

Trumbull

04074

Scarborough

01805

Burlington

08003

Cherry Hill

08736

Manasquan

87131-5636

Albuquerque

T6G 1Z2

Edmonton

Unknown

Cork

Galway

0407

Oslo

3000-075

Coimbra

1649-035

Lisbon

4200-072

Porto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY