Safety and Efficacy Study of Abraxane as Maintenance Treatment After Abraxane Plus Carboplatin in 1st Line Stage IIIB / IV Squamous Cell Non-small Cell Lung Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

427

Participants

Timeline

Start Date

February 11, 2014

Primary Completion Date

September 15, 2017

Study Completion Date

August 1, 2019

Conditions
Squamous Cell Carcinoma, Non-Small-Cell Lung
Interventions
DRUG

Abraxane (Induction)

100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 and 15 of each 21-day cycle, administered as standard of care

DRUG

Carboplatin (Induction)

6 mg/min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion

DRUG

Abraxane (Maintenance)

100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, administered as standard of care

OTHER

Best Supportive Care (Maintenance)

The best palliative care per investigator (including but not limited to: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and/or focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis), excluding antineoplastic agents

DRUG

Abraxane (Induction)

100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 and 15 of each 21-day cycle, administered as standard of care

DRUG

Carboplatin (Induction)

6 mg/min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion, administered as standard of care

OTHER

Best Supportive Care (Maintenance)

The best palliative care per investigator (including but not limited to: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and/or focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis), excluding antineoplastic agents

Trial Locations (119)

6114

Diakoniekrankenhaus Halle, Halle

10003

Beth Israel Medical Centers, New York

10016

NYU Langone Medical Center, New York

10029

Icahn School of Medicine at Mount Sinai Medical Center, New York

10461

Montefiore Medical Center, The Bronx

10467

Montefiore Medical Center Albert Einstein Cancer Center, The Bronx

11042

Clinical Research Alliance, Lake Success

NYU Langone Medical Center, Lake Success

12206

New York Oncology Hematology P.C., Albany

13210

SUNY Upstate Medical University, Syracuse

14621

Rochester General Hospital, Rochester

15212

Allegheny Singer Research Institute, Pittsburgh

15232

University of Pittsburgh Medical Center - Cancer Pavilion, Pittsburgh

16132

Istituto Nazionale Per La Ricerca Sul Cancro, Genova

16505

Erie Regional Cancer Center, Erie

17007

Intituto Catalán de Oncología de Girona, Girona

19104

Abramson Cancer Center, Philadelphia

University of Pennsylvania Health Systems, Philadelphia

20141

Istituto Europeo di Oncologia, Milan

20817

Center For Cancer and Blood Disorders, Bethesda

20900

Azienda Ospedaliera San Gerardo, Monza

21742

Meritus Medical Center, Hagerstown

23100

Azienda Ospedaliera Istituti Ospitalieri di Cremona, Cremona

25401

West Virginia University, Berkeley Medical Center, Cancer and Infusion Center, Martinsburg

25702

St Mary's Medical Center, Huntington

26506

West Virginia University, Berkeley Medical Center, Cancer and Infusion Center, Morgantown

27403

Moses H. Cone Regional Cancer Center, Greensboro

27534

Southeastern Medical Oncology Center, Goldsboro

28040

Hospital Clinico San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28204

Carolinas Medical Center, Charlotte

28222

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid

29605

Greenville Hospital System, Greenville

30607

University Cancer and Blood Center, LLC, Athens

32806

Orlando Health, Inc, Orlando

33011

Hospital Universitario Central de Asturias, Oviedo

33028

Memorial Cancer Institute West, Pembroke Pines

33136

University of Miami Miller School of Medicine Jackson Memorial Hospital, Miami

33486

Lynn Cancer Institute, Boca Raton

33612

Moffitt Cancer Center, Tampa

33705

Florida Cancer Specialists, St. Petersburg

33805

Watson Clinic, LLP Center for Cancer Care and Research, Lakeland

33916

Florida Cancer Specialists, Fort Myers

34474

Ocala Oncology Center, Ocala

35805

Clearview Cancer Institute Oncology Specialties, P.C, Huntsville

37232

Vanderbilt University Medical Center, Nashville

37404

Chattanooga Oncology Hematology Care, Chattanooga

37421

Associates in Oncology and Hematology, Chattanooga

37916

Thompson Cancer Survival Center, Knoxville

39291

Lungenklinik Lostau gGmbH, Lostau

40138

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi, Bologna

40202

Norton Healthcare, Louisville

University of Louisville, J.G. Brown Cancer Center, Louisville

40207

Norton Cancer Institute Louisville Oncology, Louisville

41701

Kentucky Cancer Clinic, Hazard

43219

The Mark H. Zangmeister Center, Columbus

43623

Toledo Community Oncology Program, Toledo

44106

University Hospitals Case Medical Center, Cleveland

44646

Tri-County Hematology and Oncology Associates, Massillon

44708

Hematology and Oncology Associates, Inc., Canton

45242

Oncology Hematology Care, Inc., Cincinnati

46014

Hospital General Universitario de Valencia, Valencia

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

46260

Investigative Clinical Research of Indiana, LLC, Indianapolis

48334

Detroit Clinical Research Center, Farmington Hills

49007

Western Michigan Cancer Center, Kalamazoo

50009

Hospital Universitario Lozano Blesa, Zaragoza

51109

Kliniken der Stadt Koln gGmbH - Krankenhaus Merheim, Cologne

52249

St. Antonius Hospital, Eschweiler

53226

Medical College of Wisconsin, Milwaukee

60435

Joliet Oncology-Hematology Associates, Ltd., Joliet

60637

University of Chicago, Chicago

60714

Illinois Cancer Specialists, Niles

63110

Washington University School of Medicine, St Louis

64507

St Joseph Oncology, Saint Joseph

65804

Mercy Medical Research Institute, Springfield

66205

Kansas University Medical Center, Westwood

66421

Universitat Des Saarlandes, Homburg

67208

Cancer Center of Kansas (MAT), Wichita

69126

Thorax Klinik, Heidelberg

70112

LSU Health Sciences Center, New Orleans

71913

Genesis Cancer Center, Hot Springs

73102

Mercy Clinic Oklahoma Communities, Inc., Oklahoma City

73104

University of Oklahoma Peggy and Charles Stephenson Cancer Center, Oklahoma City

74245

Klinik Loewenstein gGmbH, Löwenstein

75702

TX Onc Tyler Cancer Center, Tyler

76104

Center for Cancer and Blood Disorders, Fort Worth

77030

Houston Methodist Cancer Center, Houston

UT Health Oncology, Houston

77090

Millenium Oncology, Houston

80218

Rocky Mountain Cancer Centers, LLP, Denver

82131

Asklepios Fachkliniken Muenchen Gauting, Gauting

83100

Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati, Avellino

85304

Palo Verde Hematology Oncology, Ltd., Glendale

85715

Arizona Clinical Research Center, Tucson

89081

Universitatsklinikum Ulm, Ulm

90640

Clinical Trials and Research Associates, Montebello

92093

University of California San Diego Moores Cancer Center, La Jolla

93720

Cancer Care Associates of Fresno Medical Group Inc, Fresno

94304

VA Palo Alto Health Care System, Palo Alto

98039

Ospedale San Vincenzo Taormina, Taormina

98104

Swedish Cancer Institute, Seattle

99336

Columbia Basin Hematology and Oncology, Kennewick

91010-3000

City of Hope Cancer Center, Duarte

06510

Yale Cancer Center, New Haven

46202-5149

Indiana University Medical Center, Indianapolis

04210

Maine Research Associates, Auburn

04412

Eastern Maine Medical Center, Brewer

02114

Massachusetts General Hospital, Boston

02115

Beth Israel Deaconess Medical Center, Boston

07631

Englewood Hospital and Medical Center, Englewood

07960

Hematology-Oncology Associates of NNJ, P, Morristown

37203-1632

Sarah Cannon Cancer Center, Nashville

77702-1449

TX Onc, PA- Beaumont, Beaumont

78235-8200

Brooke Army Medical Center Francis Street Medical Center, Fort Sam Houston

06120

Universitatsklinikum Halle Saale, Halle

00144

Istituto Nazionale Tumori Regina Elena di Roma, Roma

OX3 7LJ

Churchhill Hospital, Oxford

SM2 5PT

Royal Marsden Hospital, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY