PAVES: Pegfilgrastim Anti-vascular Endothelial Growth Factor (VEGF) Evaluation Study

PHASE3CompletedINTERVENTIONAL
Enrollment

847

Participants

Timeline

Start Date

November 3, 2009

Primary Completion Date

September 17, 2012

Study Completion Date

January 2, 2015

Conditions
CancerColon CancerColorectal CancerFeverLocally AdvancedMetastatic Colorectal CancerNeutropeniaRectal Cancer
Interventions
DRUG

Pegfilgrastim

Administered as a single 6 mg subcutaneous injection using a pre-filled syringe. There will be no dosage adjustments for investigational product.

DRUG

Placebo

Administered as a single subcutaneous injection using a pre-filled syringe.

BIOLOGICAL

Bevacizumab

5 mg/kg by intravenous (IV) infusion on day 1 of each 14-day cycle.

DRUG

Standard Chemotherapy

"Each participant received one of the following chemotherapy regimens at the discretion of treating physician:~FOLFOX: Oxaliplatin, leucovorin, and 5-fluorouracil; FOLFIRI: Irinotecan, leucovorin and 5-flurouracil."

Trial Locations (154)

7

Research Site, Dublin

8

Research Site, Dublin

9

Research Site, Dublin

24

Research Site, Dublin

1002

Research Site, Riga

1079

Research Site, Riga

1097

Research Site, Budapest

1125

Research Site, Budapest

1606

Research Site, Sofia

1756

Research Site, Sofia

1784

Research Site, Sofia

3011

Research Site, Footscray

3058

Research Site, Coburg

3199

Research Site, Frankston

3350

Research Site, Ballarat

4012

Research Site, Debrecen

4800

Research Site, Verviers

5004

Research Site, Szolnok

5417

Research Site, Daugavpils

5700

Research Site, Gyula

6000

Research Site, Kecskemét

6720

Research Site, Szeged

7000

Research Site, Hobart

7400

Research Site, Kaposvár

8800

Research Site, Roeselare

9000

Research Site, Varna

9023

Research Site, Győr

9300

Research Site, Aalst

10960

Research Site, Nyack

11042

Research Site, Lake Success

17605

Research Site, Lancaster

19013

Research Site, Upland

19047

Research Site, Langhorne

19090

Research Site, Willow Grove

19605

Research Site, Reading

19611

Research Site, West Reading

19901

Research Site, Dover

20089

Research Site, Rozzano (MI)

20817

Research Site, Bethesda

21133

Research Site, Randallstown

21204

Research Site, Towson

21502

Research Site, Cumberland

24211

Research Site, Abingdon

24501

Research Site, Lynchburg

27103

Research Site, Winston-Salem

27262

Research Site, High Point

28030

Research Site, Colima

28602

Research Site, Hickory

28801

Research Site, Asheville

29572

Research Site, Myrtle Beach

29926

Research Site, Hilton Head Island

32605

Research Site, Gainesville

33076

Research Site, Bordeaux

33321

Research Site, Tamarac

33470

Research Site, Loxahatchee Groves

34952

Research Site, Port Saint Lucie

35661

Research Site, Muscle Shoals

37203

Research Site, Nashville

40503

Research Site, Lexington

41701

Research Site, Hazard

42001

Research Site, Paducah

44646

Research Site, Massillon

44708

Research Site, Canton

45042

Research Site, Middletown

45219

Research Site, Cincinnati

46005

Research Site, Cahors

46617

Research Site, South Bend

47150

Research Site, New Albany

49102

Research Site, Dnipropetrovsk

50080

Research Site, Toluca

50701

Research Site, Waterloo

50702

Research Site, Waterloo

51101

Research Site, Sioux City

51503

Research Site, Council Bluffs

59037

Research Site, Lille

59101

Research Site, Billings

60031

Research Site, Gurnee

60153

Research Site, Maywood

61108

Research Site, Rockford

62301

Research Site, Quincy

63136

Research Site, St Louis

64118

Research Site, Kansas City

65109

Research Site, Jefferson City

65807

Research Site, Springfield

67502

Research Site, Hutchinson

68131

Research Site, Omaha

68803

Research Site, Grand Island

68845

Research Site, Kearney

71103

Research Site, Shreveport

72401

Research Site, Jonesboro

76000

Research Site, Rouen

76018

Research Site, Ivano-Frankivsk

77802

Research Site, Bryan

78200

Research Site, San Luis Potosí City

78405

Research Site, Corpus Christi

78412

Research Site, Corpus Christi

79031

Research Site, Lviv

80000

Research Site, Amiens

82100

Research Site, Benevento

83092

Research Site, Donetsk

87131

Research Site, Albuquerque

88000

Research Site, Uzhhorod

90100

Research Site, Palermo

90211

Research Site, Beverly Hills

92161

Research Site, San Diego

92801

Research Site, Anaheim

95355

Research Site, Modesto

96813

Research Site, Honolulu

98039

Research Site, Taormina (ME)

99220

Research Site, Spokane

99336

Research Site, Kennewick

115478

Research Site, Moscow

150054

Research Site, Yaroslavl

197022

Research Site, Saint Petersburg

400015

Research Site, Cluj-Napoca

420029

Research Site, Kazan'

443031

Research Site, Samara

454087

Research Site, Chelyabinsk

550245

Research Site, Sibiu

06830

Research Site, Greenwich

02130

Research Site, Boston

02135

Research Site, Boston

03801

Research Site, Portsmouth

07739

Research Site, Little Silver

08876

Research Site, Somerville

L6R 3J7

Research Site, Brampton

P3E 5J1

Research Site, Greater Sudbury

N6A 4L6

Research Site, London

P6A 5K7

Research Site, Sault Ste. Marie

M6R 1B5

Research Site, Toronto

H7M 3L9

Research Site, Laval

G6V 3Z1

Research Site, Lévis

H2W 1S6

Research Site, Montreal

H4J 1C5

Research Site, Montreal

268 31

Research Site, Hořovice

262 04

Research Site, Nová Ves pod Pleší

775 20

Research Site, Olomouc

669 02

Research Site, Znojmo

Unknown

Research Site, Cork

Research Site, Galway

Research Site, Waterford

00133

Research Site, Roma (RM)

80-952

Research Site, Gdansk

93-509

Research Site, Lodz

10-228

Research Site, Olsztyn

16-400

Research Site, Suwałki

04-125

Research Site, Warsaw

022328

Research Site, Bucharest

022338

Research Site, Bucharest

833 10

Research Site, Bratislava

041 91

Research Site, Košice

979 01

Research Site, Rimavská Sobota

917 75

Research Site, Trnava

03115

Research Site, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT00911170 - PAVES: Pegfilgrastim Anti-vascular Endothelial Growth Factor (VEGF) Evaluation Study | Biotech Hunter | Biotech Hunter