Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer

PHASE2TerminatedINTERVENTIONAL
Enrollment

191

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

July 31, 2011

Study Completion Date

July 31, 2011

Conditions
Colorectal Neoplasms
Interventions
DRUG

sunitinib

Sunitinib: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2).

DRUG

mFOLFOX6

FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m\^2 + leucovorin 400 mg/ m\^2 (or 200 mg/ m\^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m\^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m\^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle

DRUG

bevacizumab

Bevacizumab: 5 mg/kg, IV infusion, every 2 weeks.

DRUG

mFOLFOX6

FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m\^2 + leucovorin 400 mg/ m\^2 (or 200 mg/ m\^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m\^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m\^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle

Trial Locations (97)

2100

Pfizer Investigational Site, Koebenhavn OE

2730

Pfizer Investigational Site, Herlev

9100

Pfizer Investigational Site, Aalborg

13125

Pfizer Investigational Site, Berlin

15526

Pfizer Investigational Site, Bad Saarow

19046

Pfizer Investigational Site, Meadowbrook

19087

Pfizer Investigational Site, Radnor

19090

Pfizer Investigational Site, Willow Grove

19106

Pfizer Investigational Site, Philadelphia

19107

Pfizer Investigational Site, Philadelphia

20007

Pfizer Investigational Site, Washington D.C.

21225

Pfizer Investigational Site, Baltimore

21237

Pfizer Investigational Site, Baltimore

30033

Pfizer Investigational Site, Decatur

30060

Pfizer Investigational Site, Marietta

30341

Pfizer Investigational Site, Atlanta

30342

Pfizer Investigational Site, Sandy Springs

31217

Pfizer Investigational Site, Macon

32073

Pfizer Investigational Site, Orange Park

32086

Pfizer Investigational Site, Saint Augustine

32177

Pfizer Investigational Site, Palatka

32204

Pfizer Investigational Site, Jacksonville

32207

Pfizer Investigational Site, Jacksonville

Pfizer Investigational Site, Jasonville

32250

Pfizer Investigational Site, Jacksonville Beach

32258

Pfizer Investigational Site, Jacksonville

32605

Pfizer Investigational Site, Gainesville

34994

Pfizer Investigational Site, Stuart

36532

Pfizer Investigational Site, Fairhope

36604

Pfizer Investigational Site, Mobile

38801

Pfizer Investigational Site, Tupelo

38834

Pfizer Investigational Site, Corinth

39104

Pfizer Investigational Site, Magdeburg

39705

Pfizer Investigational Site, Columbus

40225

Pfizer Investigational Site, Düsseldorf

55131

Pfizer Investigational Site, Mainz

62062

Pfizer Investigational Site, Maryville

63739

Pfizer Investigational Site, Aschaffenburg

65203

Pfizer Investigational Site, Columbia

66720

Pfizer Investigational Site, Chanute

67042

Pfizer Investigational Site, El Dorado

67068

Pfizer Investigational Site, Kingman

67114

Pfizer Investigational Site, Newton

67152

Pfizer Investigational Site, Wellington

67156

Pfizer Investigational Site, Winfield

67208

Pfizer Investigational Site, Wichita

67214

Pfizer Investigational Site, Wichita

67301

Pfizer Investigational Site, Independence

67357

Pfizer Investigational Site, Parsons

67401

Pfizer Investigational Site, Salina

67801

Pfizer Investigational Site, Dodge City

67905

Pfizer Investigational Site, Liberal

71913

Pfizer Investigational Site, Hot Springs

72703

Pfizer Investigational Site, Fayetteville

72712

Pfizer Investigational Site, Bentonville

73071

Pfizer Investigational Site, Norman

73102

Pfizer Investigational Site, Oklahoma City

73109

Pfizer Investigational Site, Oklahoma City

73120

Pfizer Investigational Site, Oklahoma City

74104

Pfizer Investigational Site, Tulsa

74133

Pfizer Investigational Site, Tulsa

74136

Pfizer Investigational Site, Tulsa

77701

Pfizer Investigational Site, Beaumont

79415

Pfizer Investigational Site, Lubbock

80045

Pfizer Investigational Site, Aurora

85206

Pfizer Investigational Site, Mesa

85224

Pfizer Investigational Site, Chandler

89052

Pfizer Investigational Site, Henderson

89128

Pfizer Investigational Site, Las Vegas

89148

Pfizer Investigational Site, Las Vegas

89169

Pfizer Investigational Site, Las Vegas

90095

Pfizer Investigational Site, Los Angeles

90277

Pfizer Investigational Site, Redondo Beach

90404

Pfizer Investigational Site, Santa Monica

91105

Pfizer Investigational Site, Pasadena

91325

Pfizer Investigational Site, Northrige

91345

Pfizer Investigational Site, Mission Hills

91355

Pfizer Investigational Site, Valencia

92835

Pfizer Investigational Site, Fullerton

93030

Pfizer Investigational Site, Oxnard

93053

Pfizer Investigational Site, Regensburg

93105

Pfizer Investigational Site, Santa Barbara

93309

Pfizer Investigational Site, Bakersfield

93436

Pfizer Investigational Site, Solvang

93454

Pfizer Investigational Site, Santa Maria

93534

Pfizer Investigational Site, Lancaster

93720

Pfizer Investigational Site, Fresno

97227

Pfizer Investigational Site, Portland

98801

Pfizer Investigational Site, Wenatchee

90095-1772

Pfizer Investigational Site, Los Angeles

90095-6984

Pfizer Investigational Site, Los Angeles

Unknown

Pfizer Investigational Site, Kashiwa

Pfizer Investigational Site, Sapporo

Pfizer Investigational Site, Kitaadachi-gun, Ina-cho

Pfizer Investigational Site, Suntougun

Pfizer Investigational Site, Utsunomiya

Pfizer Investigational Site, Chuo-ku

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT00609622 - Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer | Biotech Hunter | Biotech Hunter