A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen

PHASE2CompletedINTERVENTIONAL
Enrollment

171

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

March 31, 2011

Study Completion Date

April 30, 2012

Conditions
Colorectal Neoplasms
Interventions
DRUG

Bevacizumab (avastin)

Bevacizumab intravenous \[IV\] infusion 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent.

DRUG

FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU])

Irinotecan (180 mg/m²) intravenous infusion \[IV\] over 90 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed immediately by 5-FU bolus (400 mg/m²) intravenous \[IV\] and a subsequent 5-FU infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.

DRUG

AG-013736 (axitinib)

Axitinib is given at a starting dose of 5 mg twice daily \[BID\] continuous dosing until disease progression, intolerance or withdrawal of consent.

DRUG

FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])

Oxaliplatin (85 mg/m²) intravenous infusion \[IV\] over 120 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed by 5-FU IV bolus (400 mg/m²) and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.

DRUG

AG-013736 (axitinib)

Axitinib is given at a starting dose of 5 mg twice daily \[BID\] continuous dosing until disease progression, intolerance or withdrawal of consent.

DRUG

FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU])

Irinotecan (180 mg/m²) intravenous infusion \[IV\] over 90 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed immediately by 5-FU bolus (400 mg/m²) IV and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.

DRUG

Bevacizumab (avastin)

Bevacizumab intravenous infusion \[IV\] 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent.

DRUG

FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])

Oxaliplatin (85 mg/m²) IV infusion over 120 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed by 5-FU IV bolus (400 mg/m²) and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.

Trial Locations (83)

16132

Pfizer Investigational Site, Genova

21237

Pfizer Investigational Site, Baltimore

23114

Pfizer Investigational Site, Midlothian

23116

Pfizer Investigational Site, Mechanicsville

23230

Pfizer Investigational Site, Richmond

23235

Pfizer Investigational Site, Richmond

28033

Pfizer Investigational Site, Madrid

30318

Pfizer Investigational Site, Atlanta

30736

Pfizer Investigational Site, Ringgold

33905

Pfizer Investigational Site, Fort Myers

33908

Pfizer Investigational Site, Fort Myers

33914

Pfizer Investigational Site, Cape Coral

33916

Pfizer Investigational Site, Fort Myers

33980

Pfizer Investigational Site, Port Charlotte

33990

Pfizer Investigational Site, Cape Coral

34094

Pfizer Investigational Site, Montpellier

34102

Pfizer Investigational Site, Naples

34119

Pfizer Investigational Site, Naples

34135

Pfizer Investigational Site, Bonita Springs

34209

Pfizer Investigational Site, Bradenton

34223

Pfizer Investigational Site, Englewood

34232

Pfizer Investigational Site, Sarasota

34236

Pfizer Investigational Site, Sarasota

34285

Pfizer Investigational Site, Venice

34292

Pfizer Investigational Site, Venice

35128

Pfizer Investigational Site, Padua

36608

Pfizer Investigational Site, Mobile

37066

Pfizer Investigational Site, Gallatin

37067

Pfizer Investigational Site, Franklin

37076

Pfizer Investigational Site, Hermitage

37087

Pfizer Investigational Site, Lebanon

37130

Pfizer Investigational Site, Murfreesboro

37167

Pfizer Investigational Site, Smyrna

37203

Pfizer Investigational Site, Nashville

37205

Pfizer Investigational Site, Nashville

37207

Pfizer Investigational Site, Nashville

37211

Pfizer Investigational Site, Nashville

37232

Pfizer Investigational Site, Nashville

37343

Pfizer Investigational Site, Hixson

37404

Pfizer Investigational Site, Chattanooga

38138

Pfizer Investigational Site, Germantown

38242

Pfizer Investigational Site, Paris

38261

Pfizer Investigational Site, Union City

38652

Pfizer Investigational Site, New Albany

41017

Pfizer Investigational Site, Crestview Hills

42002

Pfizer Investigational Site, Paducah

42003

Pfizer Investigational Site, Paducah

45013

Pfizer Investigational Site, Hamilton

45014

Pfizer Investigational Site, Fairfield

45219

Pfizer Investigational Site, Cincinnati

45230

Pfizer Investigational Site, Cincinnati

45236

Pfizer Investigational Site, Cincinnati

45238

Pfizer Investigational Site, Cincinnati

45242

Pfizer Investigational Site, Cincinnati

45248

Pfizer Investigational Site, Cincinnati

52001

Pfizer Investigational Site, Dubuque

59020

Pfizer Investigational Site, Lille

75012

Pfizer Investigational Site, Paris

78463

Pfizer Investigational Site, Corpus Christi

80045

Pfizer Investigational Site, Aurora

90095

Pfizer Investigational Site, Los Angeles

90404

Pfizer Investigational Site, Santa Monica

94523

Pfizer Investigational Site, Pleasant Hill

94531

Pfizer Investigational Site, Antioch

94578

Pfizer Investigational Site, San Leandro

94805

Pfizer Investigational Site, Villejuif

90095-6984

Pfizer Investigational Site, Los Angeles

33901-8108

Pfizer Investigational Site, Fort Myers

J4V 2H1

Pfizer Investigational Site, Greenfield Park

G6V 3Z1

Pfizer Investigational Site, Lévis

H2X 3J4

Pfizer Investigational Site, Montreal

00152

Pfizer Investigational Site, Roma

00168

Pfizer Investigational Site, Roma

Unknown

Pfizer Investigational Site, Kashiwa

Pfizer Investigational Site, Suntougun

Pfizer Investigational Site, Chuo-ku

02-097

Pfizer Investigational Site, Warsaw

02-781

Pfizer Investigational Site, Warsaw

700-721

Pfizer Investigational Site, Daegu

519-809

Pfizer Investigational Site, Jeollanam-do

139-706

Pfizer Investigational Site, Seoul

08907

Pfizer Investigational Site, L'Hospitalet de Llobregat

08208

Pfizer Investigational Site, Sabadell

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY