Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas

PHASE3CompletedINTERVENTIONAL
Enrollment

861

Participants

Timeline

Start Date

March 1, 2009

Primary Completion Date

September 17, 2012

Study Completion Date

April 9, 2013

Conditions
Metastatic Pancreatic Cancer
Interventions
DRUG

Albumin-bound paclitaxel (ABI-007)

ABI-007 125 mg/m\^2 administered by intravenous infusion

DRUG

Gemcitabine

Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward).

Trial Locations (193)

1070

Hôpital Erasme, Gastro-Enterology, Brussels

1090

Medizinische Universität Wien, Vienna

2010

St. Vincent's Hospital, Darlinghurst

2031

Prince of Wales Hospital, Randwick

2139

Concord Hospital, Concord

2200

Bankstown-Lidcombe Hospital, Bankstown

2298

Newcastle Hospital, Waratah

2500

Southern Medical Day Care Centre, Wollongong

2560

Macarthur Cancer Therapy Center, Campbelltown

2820

Imelda VZW , Gastro-Enterology, Bonheiden

3004

Alfred Hospital, Melbourne

3011

Western Hospital, Footscray

3039

Kyiv City Clinical Hospital #10, Center for Hepatic, Bile Duct and Pancreatic Surgery, Kyiv

3100

Landesklinikum St. Pölten, Sankt Pölten

3165

Monash Medical Centre, East Bentleigh

3199

Peninsula Oncology Centre, Frankston

3552

Medical Oncology Unit, Bendigo Health, Bendigo

3690

Border Medical Oncology, Wodonga

4010

Krankenhaus der Barmherzigen Schwestern Linz, Linz

4029

Royal Brisbane and Women's Hospital, Herston

4101

Haemotology & Oncology Australasia (HOCA), Milton

4215

Haematology Oncology Clinics of Australasia-Gold Coast, Milton

4600

Klinikum Wels-Grieskirchen GmbH, Wels

5006

Calvary North Adelaide Hospital, North Adelaide

5035

Adelaide Cancer Centre (T/A Ashford Cancer Ctr), Ashford

5042

Flinders Medical Center, Bedford Park

6009

Sir Charles Gairdner Hospital, Nedlands, Perth

7000

Royal Hobart Hospital, Hobart

8036

Hospital Clinic i Provincial, Barcelona

8500

AZ Groeninge - Campus Sint-Niklaas, Kortrijk

8800

H.-Hartziekenhuis Roeselare-Menen vzw, Roeselare

10008

O.F. Herbachevskyi Regional Clinical Hospital, Surgery Center, Zhytomyr

11042

Arena Oncology Associates, PC, Lake Success

12206

New York Oncology Hematology PC, Albany

13210

SUNY Upstate Medical University, Syracuse

14004

Hospital Universitario Reina Sofia, Córdoba

14263

Roswell Park Cancer Institute, Buffalo

15232

University of Pittsburg Medical Center, Pittsburgh

16128

E. O. Ospedali Galliera, Struttura Complessa Oncologia Medica, Genova

16132

Nazionale per la Ricerca sul Cancro, Genova

19047

St. Mary Medical Center Hem-Onc Group, PC, Langhorne

20089

Istituto Clinico Humanitas, Rozzano

20132

Fondazione Centro San Raffaele del Monte Tabor, Milan

20162

Oncologia Medica Falck, Milan

20817

Center for Cancer & Blood Disorders, Bethesda

21231

Sidney Kimmel Comphrensive Cancer Center, John Hopkins University, Baltimore

22031

Fairfax-Northern Virginia Hematology-Oncology, P.C., Fairfax

Virginia Cancer Specialist, PC, Fairfax

23230

Virginia Cancer Institute, Richmond

25031

Kirovohrad Regional Oncology Center, Department of Chemotherapy, Kirovohrad

26133

Klinikum Oldenburg, Oldenburg

27100

IRCCS Policlinico San Matteo, Pavia

27103

Piedmont Hematology Oncology, Winston-Salem

28034

Hospital Universitario Ramón y Cajal, Madrid

28040

Hospital Clinico San Carlos, Madrid

28041

Hospital 12 de Octubre, Madrid

28050

Centro Integral Oncológico Clara Campal, Madrid

29210

South Carolina Oncology Associates, Columbia

30309

Piedmont Hospital Research Institute, Atlanta

30341

Georgia Cancer Specialists, Atlanta

30342

Atlanta Cancer Care, Atlanta

30607

Northeast Georgia Cancer Care, LLC, Athens

31701

Phoebe Putney Cancer Center, Albany

32778

Lake County Oncology and Hematology, Tavares

32804

Florida Hospital Cancer Institute, Orlando

33426

University Cancer Institute, LLC, Boynton Beach

33435

Collaborative Research Group, Boynton Beach

33805

Lakeland Regional Cancer Center, Lakeland

33916

FL Cancer Specialist, Fort Myers

34471

Ocala Oncology Center, Ocala

35128

Istituto Oncologico Veneto, Padua

35294

UAB Comprenhensive Cancer Center at University of Alabama, Birmingham

35805

Clearview Cancer Institute Oncology Specialities, P.C., Huntsville

37134

Azienda Ospedaliera Universitaria Integrata di Verona, Verona

37203

Tennessee Oncology, Nashville

37404

Chattanooga Oncology Hematology Associates, Chattanooga

40245

Owsley Brown Frazier Cancer Center, Louisville

41013

Hospital Virgen del Rocio, Seville

42100

Arcispedale Santa Maria Nuova, Unità Operativa di Oncologia Medica, Reggio Emilia

Arcispedale Santa Maria Nuova, Reggio Emilia

43018

Volyn Regional Oncology Center Department of Oncochemotherapy, Lutsk

43219

Mid Ohio Oncology/Hematology Inc, Columbus

45042

Signal Point Clinical Research Center, LLC, Middletown

45136

Kliniken Essen-Mitte, Essen

45242

Oncology Hematology Care, Cincinnati

45429

Kettering Medical Center, Kettering

46202

Indiana University Simon Cancer Center, Indianapolis

49102

Dnepropetrovsk City Hosp #4, Dnipro

49933

Centre Regional de lutte contre le cancer Paul Papin, Angers

53226

Medical College of Wisconsin, Milwaukee

55408

Virginia Piper Cancer Institute, Minneapolis

55455

University of Minnesota, Masonic Cancer Center, Minneapolis

55805

St. Mary's/ Duluth Clinic, Duluth

56126

Azienda Ospedaliero universitaria Pisana, Pisa

60005

Cancer Care & Hemaotology Specialists of Chicagoland, Arlington Heights

60021

NorthShore University HealthSystem, Evanston

60076

Orchard Research, Skokie

60714

Cancer Care & Hematology Specialists of Chicagoland, Niles

61070

Kharkov Regional Onc Ctr, Kharkiv

61615

Illinois Cancer Care, Peoria

63110

Saint Louis University, St Louis

65055

Odessa Regional Onc Ctr, Odesa

65807

St. John's Medical Research Institute, Springfield

67502

Hutchinson Clinic, PA, Hutchinson

69096

Zaporizhia Medical Academy of Postgraduate Education, Zaporizhia

70124

"I.R.C.C.S. Giovanni Paolo II - Istituto Oncologico", Bari

70809

Hematology Oncology Clinic, Baton Rouge

Mary Bird Perkins Cancer Center, Baton Rouge

71013

Ospedale Casa Sollievo della Sofferenza IRCCS, San Giovanni Rotondo, Foggia

71913

Genesis Cancer Center, Hot Springs

73000

Kherson Regional Onc Ctr, Kherson

73104

University of Oklahoma Health Science Center, Oklahoma City

73112

Mercy Physicians of Oklahoma, Oklahoma City

73505

Cancer Centers of SW OK, Lawton

74104

Cancer Care Associates- Tulsa, Tulsa

75075

Texas Oncology- Plano East, Plano

75237

Texas Oncology, PA/ Methodist Charlton Cancer Center, Dallas

75571

Hôpital Saint Antoine, Paris

76104

Texas Oncology Laboratories, Fort Worth

The Center for Cancer and Blood Disorders, Fort Worth

76310

Texas Oncology, PA, Wichita Falls

76885

Texas Oncology, PA, Round Rock

77030

The University of Texas Medical School at Houston, Houston

78229

South Texas Oncology and Hematology, P.A, San Antonio

78681

Texas Oncology-Round Rock, Round Rock

79031

Lviv Regional Diagnostics and Treatment and Diagnostics Onc Ctr, Lviv

80045

University of Colorado Cancer Center, Aurora

80218

Rocky Mountain Cancer Center, Denver

81377

LMU Klinikum der Universität, Munich

83092

Donetsk Regional Antitumor Ctr, Donetsk

84106

Utah Cancer Specialists, Salt Lake City

84112

Huntsman Cancer Institute, Salt Lake City

85258

TGEN Clinical Research Services at Scottsdale Healthcare, Scottsdale

85259

Mayo Clinic-Scottsdale, Scottsdale

85354

Klinikum Freising, Freising

85724

Arizona Cancer Center, University of Arizona, Tucson

86336

Northern Arizona Hematology and Oncology Associates-AOA, Sedona

87106

Hem Onc Associates-NM, Albuquerque

88045

Praxis für Innere Medizin, Dr. Oettle Helmut, Friedrichshafen

90024

UCLA, Los Angeles

90211

Tower Cancer Research Foundation, Beverly Hills

90813

Pacific Shores Medical Group, Long Beach

91010

City of Hope, Duarte

92118

Hôpital Beaujon, Paris

92270

Desert Hematology Oncology Medical Group, Inc., Rancho Mirage

97070

Universitätsklinikum Würzburg, Würzburg

98104

Swedish Health Services, Seattle

98109

Fred Hutchinson Cancer Research Center, Seattle

99218

Evergreen Hematology & Oncology, Spokane

105077

Moscow City Clinical Hosp #57 Chemotherapy Dept, Moscow

115478

Blokhin Cancer Research Center, Moscow

117997

Russian Res Ctr of Radiology under the Fed Agency for Hi-Tech Med Care, Moscow

119992

Russian Research Ctr of Surgery n.a. B.V. Petrovskiy under the Russian Academy of Med Sciences, Moscow

121356

Central Clinical Hosp of the President of the Russian Federation, Moscow

129128

Semashko Central Hosp #2, Moscow

143423

Moscow Municipal Onc Hosp #62, Moscow Region

150054

Yaroslavl Regional Onc Ctr, Yaroslavl

153013

Ivanovo Regional Oncology Center, Ivanovo

194291

Clinical Hosp # 122 n.a. L.G. Sokolov, Saint Petersburg

Leningrad Regional Clinical Hosp, Saint Petersburg

195067

St. Petersburg State Med Academy n.a.Mechnikov, Saint Petersburg

197758

Russian Research Ctr for Radiology and Surgical Technologies, Saint Petersburg

198255

St. Petersburg City Onc Ctr, Saint Petersburg

249036

Med Radiological Centre of the Russian Academy of Med Sciences, Obninsk

300053

Tula Regional Oncology Center, Tula

357500

Pyatigorsk Affiliate of Stavropol Regional Onc Ctr, Pyatigorsk

420029

Tatarstan Republican Onc Ctr, Kazan'

450054

Bashkortostan Republican Onc Ctr, Ufa

454087

Chelyabinsk Regional Onc Ctr, Chelyabinsk

455001

Regional Oncological Center # 2, Magnitogorsk

460021

Orenburg Regional Onc Ctr, Orenburg

610013

Omsk Regional Onc Ctr, Omsk

656049

Altai Territorial Oncological Center, Barnaul

04240

Central Maine Medical Center, Lewiston

04102

Mercy Hospital Portland, ME, Portland

04074

Maine Center for Cancer Medicine, Scarborough

01805

Lahey Clinic, Burlington

01655

Cancer Center of Excellence/University of MA Medical School, Worcester

08003

The Center for Cancer and Hematologic Disease, Cherry Hill

87131-0001

University of New Mexico, Albuquerque

75230-2510

Medical City Dallas-US Oncology, Dallas

75231-4400

Texas Oncology, PA, Dallas

23298-0037

Virginia Commonwealth University, Richmond

T2N 4N2

Tom Baker Cancer Centre, Calgary

V5Z 4E6

BC Cancer Agency-Vancouver, Vancouver

L4M6M2

The Royal Victoria Hospital-Barrie, Barrie

H4J 1C5

Hopital du Sacre-Coeur, Montreal

H2X3J4

Centre Hospitalier de L'Universite de Montreal St-Luc, Montreal

M5G 2M9

Princess Margaret Hospital, Ontario

G1R 2J6

Hotel-Dieu de Quebec, Québec

00144

"Istituto Nazionale Tumori Regina Elena", Roma

08035

Hospital Vall D´Hebron, Barcelona

03022

National Institute of Cancer, Department of Tumors of Abdominal Cavity and Retroperitoneum, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY

NCT00844649 - Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas | Biotech Hunter | Biotech Hunter