AzTrials
AzTrials

Lung CancerPhase 3NCT01107626

Bevacizumab or Pemetrexed Disodium Alone or In Combination After Induction Therapy in Treating Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

A Phase 3 study testing Paclitaxel, Carboplatin and Bevacizumab in people with Lung Cancer, run by ECOG-ACRIN Cancer Research Group at 434 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Paclitaxel, Carboplatin and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,516 participants
Where
434 sitesUnited States
Study dates
25 Oct 2010to 17 Aug 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cytologically or histologically confirmed non-small cell lung cancer (NSCLC)
  • Predominant non-squamous histology (NSCLC not otherwise specified allowed). Mixed tumors are categorized by the predominant cell type.
  • Stage IV disease including M1a or M1b stages or recurrent disease
  • Stage IIIB (T4NX) disease with ipsilateral lung lobe allowed provided patients are not candidates for combined chemotherapy or radiotherapy
  • At least 12 months since prior adjuvant chemotherapy
  • At least 2 weeks since prior radiotherapy
Show all 24Show fewer
  • Prior carboplatin allowed provided it was given as part of adjuvant chemotherapy
  • Patients with brain metastasis must have received local therapy to the brain and have no evidence of progression in the brain for at least 2 weeks from the time of completion of local therapy, prior to registration
  • ECOG (Eastern Cooperative Oncology Group) performance status 0-1
  • Leukocytes ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Total bilirubin ≤ institutional upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN
  • Creatinine ≤ institutional ULN OR creatinine clearance ≥ 60 mL/min
  • Urine protein:urine dipstick ≤ 0-1+ (if > 1+, urine protein creatinine ratio must be < 1)
  • Measurable or non-measurable disease as defined by RECIST (Response Evaluation Criteria in Solid Tumours) criteria
  • Patients with hypertension must be adequately controlled (BP < 150/100 mm Hg) with appropriate anti-hypertensive therapy or diet
  • Concurrent therapeutic anti-coagulation allowed
  • Fertile patients must agree to abstain from sexual intercourse or to use adequate contraceptive methods during and for at least 6 months after completion of study therapy
  • Patient must have an overall stable or better response after 4 courses of induction therapy
  • ECOG (Eastern Cooperative Oncology Group) performance status 0-1
  • Patients must be registered to Step 2 within 6 weeks of the last day of chemotherapy administration on Step 1
  • Acceptable bone marrow, renal and hepatic function within 2 weeks of registration

Who cannot join

  • Prior malignancy within the past 3 years except superficial melanoma, basal cell carcinoma, or carcinoma in situ
  • Prior systemic chemotherapy for advanced stage lung cancer
  • Prior use of paclitaxel, pemetrexed disodium, or bevacizumab
  • Major hemoptysis within the past 4 weeks
  • Uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, psychiatric illness/social situations that would limit compliance with study requirements
  • History of arterial thrombotic events or major bleeding within the past 12 months
Show all 15Show fewer
  • Major surgery such as thoracotomy, laparotomy, craniotomy, or significant traumatic injury within 6 weeks prior to registration. Biopsy procedures and chest tube insertion are not considered major surgery for the purpose of this protocol.
  • Core biopsy within 7 days of registration
  • Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within the past 6 months
  • Clinically significant cardiovascular disease
  • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • History of serious non-healing wounds, ulcers, or bone fractures
  • Cavitary lesions in the lungs
  • Pregnant or nursing
  • Concurrent anti-retroviral therapy in patients with HIV infection

Trial locations and contacts

434 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Oncology Services of Aberdeen

    Aberdeen, South Dakota, 57401

  • Hendrick Cancer Center

    Abilene, Texas, 79601

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • Phoebe Cancer Center at Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • AnMed Cancer Center

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Regional Medical Center

    Anniston, Alabama, 36207

  • Langlade Memorial Hospital

    Antigo, Wisconsin, 54409

  • Randolph Hospital

    Asheboro, North Carolina, 27203-5400

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Sturdy Memorial Hospital

    Attleboro, Massachusetts, 02703

  • Auburn Regional Center for Cancer Care

    Auburn, Washington, 98002

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

  • Aurora Presbyterian Hospital

    Aurora, Colorado, 80012

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60504

  • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

    Baltimore, Maryland, 21215

  • Kaiser Permanente at Woodlawn Medical Center

    Baltimore, Maryland, 21244

  • CancerCare of Maine at Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Ochsner Health Center - Bluebonnet

    Baton Rouge, Louisiana, 70809

  • Cleveland Clinic Beachwood Family Health and Surgery Center

    Beachwood, Ohio, 44122

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • Overlake Cancer Center at Overlake Hospital Medical Center

    Bellevue, Washington, 98004

  • MeritCare Bemidji

    Bemidji, Minnesota, 56601

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59102

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center Cancer Center

    Bismarck, North Dakota, 58502

  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Mountain States Tumor Institute at St. Luke's Regional Medical Center

    Boise, Idaho, 83712

  • Central Care Cancer Center at Carrie J. Babb Cancer Center

    Bolivar, Missouri, 65613

  • Boulder Community Hospital

    Boulder, Colorado, 80301-9019

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • St. Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Skaggs Cancer Center at Skaggs Regional Medical Center

    Branson, Missouri, 65616

  • Maimonides Cancer Center at Maimonides Medical Center

    Brooklyn, New York, 11219

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Mercy Cancer Center at Mercy Medical Center

    Canton, Ohio, 44708

  • Aultman Cancer Center at Aultman Hospital

    Canton, Ohio, 44710-1799

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • Iowa Blood and Cancer Care

    Cedar Rapids, Iowa, 52402

  • St. Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Providence Centralia Hospital

    Centralia, Washington, 98531-9027

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • West Virginia University Health Sciences Center - Charleston

    Charleston, West Virginia, 25304

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Hematology and Oncology Associates

    Chicago, Illinois, 60611

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612-7243

  • Veterans Affairs Medical Center - Chicago Westside Hospital

    Chicago, Illinois, 60612

  • Swedish Covenant Hospital

    Chicago, Illinois, 60625

  • Resurrection Medical Center

    Chicago, Illinois, 60631

  • Louis A. Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Saint Joseph Hospital

    Chicago, Illinois, 60657

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • MetroHealth Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Cancer Center at Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Medical Oncology and Hematology Associates - West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center - West Lakes

    Clive, Iowa, 50325

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Heartland Oncology and Hematology

    Council Bluffs, Iowa, 51503

  • Ochsner Health Center - Covington

    Covington, Louisiana, 70433

  • Regional Cancer Center at Western Maryland Health System - Sacred Heart Campus

    Cumberland, Maryland, 21502

  • Praxair Cancer Center at Danbury Hospital

    Danbury, Connecticut, 06810

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Mercy Fitzgerald Hospital

    Darby, Pennsylvania, 19023

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • CCOP - Dayton

    Dayton, Ohio, 45420

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Veterans Affairs Medical Center - Atlanta (Decatur)

    Decatur, Georgia, 30033

  • North Broward Medical Center

    Deerfield Beach, Florida, 33064-3596

  • St. Anthony Central Hospital

    Denver, Colorado, 80204

  • Kaiser Permanente - Denver

    Denver, Colorado, 80205

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • St. Joseph Hospital

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • CCOP - Colorado Cancer Research Program

    Denver, Colorado, 80222

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa, 50314

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Seacoast Cancer Center at Wentworth - Douglass Hospital

    Dover, New Hampshire, 03820

  • Duluth Clinic Cancer Center - Duluth

    Duluth, Minnesota, 55805-1983

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller - Dwan Medical Center

    Duluth, Minnesota, 55805

  • Cancer Centers of the Carolinas - Easley

    Easley, South Carolina, 29640

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07018-1095

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • Community Cancer Center

    Elyria, Ohio, 44035

  • Hematology Oncology Center

    Elyria, Ohio, 44035

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • Ephrata Cancer Center at Ephrata Community Hospital

    Ephrata, Pennsylvania, 17522

  • Regional Cancer Center - Erie

    Erie, Pennsylvania, 16505

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • St. Francis Hospital

    Evanston, Illinois, 60202

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • North Bay Cancer Center

    Fairfield, California, 94533

  • MeritCare Broadway

    Fargo, North Dakota, 58102

  • Dakota Cancer Institute at Dakota Clinic - South University

    Fargo, North Dakota, 58103

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • Roger Maris Cancer Center at MeritCare Hospital

    Fargo, North Dakota, 58122

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

  • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Broward General Medical Center Cancer Center

    Fort Lauderdale, Florida, 33316

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Frederick Memorial Hospital Regional Cancer Therapy Center

    Frederick, Maryland, 21701

  • Fredericksburg Oncology, Incorporated

    Fredericksburg, Virginia, 22401

  • Leonard C. Ferguson Cancer Center

    Freeport, Illinois, 61032

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Mountain States Tumor Institute - Fruitland

    Fruitland, Idaho, 83619

  • Fox Chase Cancer Center Buckingham

    Furlong, Pennsylvania, 18925

  • Kaiser Permanente - Gaithersburg Medical Center

    Gaithersburg, Maryland, 20879

  • Delnor Hospital - Geneva

    Geneva, Illinois, 60134

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Charles R. Wood Cancer Center at Glens Falls Hospital

    Glens Falls, New York, 12801

  • Addison Gilbert Hospital

    Gloucester, Massachusetts, 01930

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439

  • Altru Cancer Center at Altru Hospital

    Grand Forks, North Dakota, 58201

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54301-3526

  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27403-1198

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Bon Secours St. Francis Health System

    Greenville, South Carolina, 29601

  • Cancer Centers of the Carolinas - Faris Road

    Greenville, South Carolina, 29605

  • Cancer Centers of the Carolinas - Grove Commons

    Greenville, South Carolina, 29605

  • Greenville Hospital Cancer Center

    Greenville, South Carolina, 29605

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Cancer Centers of the Carolinas - Greer Medical Oncology

    Greer, South Carolina, 29650

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Virginia Oncology Associates - Hampton

    Hampton, Virginia, 23666

  • Cherry Tree Cancer Center

    Hanover, Pennsylvania, 17331

  • PinnacleHealth Regional Cancer Center at Polyclinic Hospital

    Harrisburg, Pennsylvania, 17110-2098

  • Helen and Harry Gray Cancer Center at Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Geisinger Hazleton Cancer Center

    Hazleton, Pennsylvania, 18201

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Kellogg Cancer Care Center

    Highland Park, Illinois, 60035

  • Hinsdale Hematology Oncology Associates

    Hinsdale, Illinois, 60521

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Cleveland Clinic Cancer Center

    Independence, Ohio, 44131

  • Dickinson County Healthcare System

    Iron Mountain, Michigan, 49801

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • West Tennessee Cancer Center at Jackson-Madison County General Hospital

    Jackson, Tennessee, 38301

  • Mercy Regional Cancer Center

    Janesville, Wisconsin, 53547

  • Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • St. John's Regional Medical Center

    Joplin, Missouri, 64804

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Provena St. Mary's Regional Cancer Center - Kankakee

    Kankakee, Illinois, 60901

  • Providence Medical Center

    Kansas City, Kansas, 66112

  • Saint Luke's Cancer Institute at Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Heartland Hematology Oncology Associates, Incorporated

    Kansas City, Missouri, 64118

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37662

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Cascade Cancer Center at Evergreen Hospital Medical Center

    Kirkland, Washington, 98033

  • Gundersen Lutheran Center for Cancer and Blood

    La Crosse, Wisconsin, 54601

  • La Grange Memorial Hospital

    La Grange, Illinois, 60525

  • Kaiser Permanente - Lafayette

    Lafayette, Colorado, 80026

  • Clarian Arnett Cancer Care

    Lafayette, Indiana, 47904

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17604

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility

    Largo, Maryland, 20774

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • St. Joseph Regional Medical Center

    Lewiston, Idaho, 83501

  • Lewistown Hospital

    Lewistown, Pennsylvania, 17044

  • Parvin Radiation Oncology

    Liberty, Missouri, 64068

  • North Shore Oncology and Hematology Associates, Limited - Libertyville

    Libertyville, Illinois, 60048

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Cancer Resource Center - Lincoln

    Lincoln, Nebraska, 68510

  • Littleton Adventist Hospital

    Littleton, Colorado, 80122

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Todd Cancer Institute at Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • Hope Cancer Care Center at Longmont United Hospital

    Longmont, Colorado, 80501

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Holy Family Memorial Medical Center Cancer Care Center

    Manitowoc, Wisconsin, 54221-1450

  • Immanuel St. Joseph's

    Mankato, Minnesota, 56002

  • HealthEast Cancer Care at St. John's Hospital

    Maplewood, Minnesota, 55109

  • Minnesota Oncology - Maplewood

    Maplewood, Minnesota, 55109

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Vince Lombardi Cancer Clinic - Marinette

    Marinette, Wisconsin, 54143

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

    Marlton, New Jersey, 08053

  • Upper Michigan Cancer Center at Marquette General Hospital

    Marquette, Michigan, 49855

  • Mercy Cancer Center at Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537-1839

  • Hillcrest Cancer Center at Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • Kaiser Permanente Tysons Corner Medical Center

    McLean, Virginia, 22102

  • Riddle Memorial Hospital Cancer Center

    Media, Pennsylvania, 19063

  • Mountain States Tumor Institute - Meridian

    Meridian, Idaho, 83642

  • Suniti Medical Corporation

    Merrillville, Indiana, 46410

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Southwest General Health Center

    Middleburg Heights, Ohio, 44130

  • Wheaton Franciscan Cancer Care - St. Joseph

    Milwaukee, Wisconsin, 53210

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Trinity CancerCare Center

    Minot, North Dakota, 58701

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Louisiana State University Health Sciences Center - Monroe

    Monroe, Louisiana, 71210

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital - Monroe

    Monroe, Michigan, 48162

  • Community Hospital of the Monterey Peninsula Comprehensive Cancer Center

    Monterey, California, 93940

  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals

    Morgantown, West Virginia, 26506

  • Carol G. Simon Cancer Center at Morristown Memorial Hospital

    Morristown, New Jersey, 07960

  • D.N. Greenwald Center

    Mukwonago, Wisconsin, 53149

  • Saint Luke's Mountain States Tumor Institute

    Nampa, Idaho, 83686

  • Oncology Center at St. Joseph Hospital

    Nashua, New Hampshire, 03060

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus

    New Britain, Connecticut, 06050

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Medical Center of Louisiana - New Orleans

    New Orleans, Louisiana, 70112

  • New Orleans Cancer Institute at Memorial Medical Center

    New Orleans, Louisiana, 70115

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • Ochsner Cancer Institute at Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • UMDNJ University Hospital

    Newark, New Jersey, 07103

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Cancer Care and Hematology Specialists of Chicagoland - Niles

    Niles, Illinois, 60714

  • Cancer Care Associates - Norman

    Norman, Oklahoma, 73071

  • Southwest Virginia Regional Cancer Center at Wellmonth Health

    Norton, Virginia, 24273

  • Regional Cancer Center at Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • Green Bay Oncology, Limited - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • Cancer Care Associates - Mercy Campus

    Oklahoma City, Oklahoma, 73120

  • Providence St. Peter Hospital Regional Cancer Center

    Olympia, Washington, 98506-5166

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegant Health Cancer Center at Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Lakeside Hospital

    Omaha, Nebraska, 68130

  • Creighton University Medical Center

    Omaha, Nebraska, 68131-2197

  • UHHS Chagrin Highlands Medical Center

    Orange, Ohio, 44122

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic - Oregon

    Oregon, Ohio, 43616

  • Florida Hospital Cancer Institute at Florida Hospital Orlando

    Orlando, Florida, 32803-1273

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • McCreery Cancer Center at Ottumwa Regional

    Ottumwa, Iowa, 52501

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Saint Luke's Hospital - South

    Overland Park, Kansas, 66213

  • Mitchell Memorial Cancer Center at Owensboro Medical Health System

    Owensboro, Kentucky, 42303

  • Veterans Affairs Medical Center - Palo Alto

    Palo Alto, California, 94304

  • Cancer Center of Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301-1792

  • Feather River Hospital Cancer Center

    Paradise, California, 95969

  • Parker Adventist Hospital

    Parker, Colorado, 80138

  • Parma Community General Hospital

    Parma, Ohio, 44129

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Sacred Heart Cancer Center at Sacred Heart Hospital

    Pensacola, Florida, 32504

Other trials in United States

About this study

Official title: Randomized Phase III Study of Maintenance Therapy With Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Pemetrexed disodium may stop the growth of tumor cells by blocking some enzymes needed for cell growth. It is not yet known whether giving bevacizumab or pemetrexed disodium alone or in combination is more effective in treating non-squamous non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying bevacizumab and pemetrexed disodium alone or in combination after induction therapy to see how well they work in treating patients with advanced non-squamous non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To compare the overall survival (OS) of patients with advanced non-squamous non-small cell lung cancer (NSCLC) treated with maintenance therapy with bevacizumab vs pemetrexed disodium vs bevacizumab and pemetrexed disodium following induction therapy.

Secondary

  • To determine the response rate in patients treated with these regimens.
  • To evaluate the progression-free survival (PFS) of patients treated with these regimens.
  • To define the toxicity of these regimens in these patients.
  • To determine the frequency of polymorphisms in VEGF 3578 AA, 1154 AA, ABCB1 G2677TT/AA, and ERCC-118 TT in patients treated with induction therapy comprising paclitaxel, carboplatin and bevacizumab and determine the association between genotypes and response rate.
  • To determine the association between bevacizumab and pemetrexed disodium population pharmacokinetics and patient-specific covariate with bevacizumab or pemetrexed disodium toxicity.
  • To determine the frequency of TSER*3 polymorphisms in NSCLC and the association between TSER polymorphisms and benefit from pemetrexed disodium.
  • To evaluate TS and ERCC1 expression by RT-PCR and MTAP mutations in existing tumor specimens as a predictor of pemetrexed disodium response.
  • To evaluate polymorphisms within CYPs 2C8, 3A4, 3A5 and/or the UGT1A1 collectively or monogenically as markers for variation in efficacious and/or toxic response of individuals to treatment with taxanes.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to gender (male vs female), stage of disease (IIIB-T4Nx [with nodule in ipsilateral lung lobe and not candidate for combined chemotherapy and radiation] and IV M1a vs IV M1b vs recurrent), best response to first-time therapy (complete response/partial response vs stable disease), and smoking status (never vs smoker).

  • Induction therapy (Arm I): Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
  • Maintenance Therapy: Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Treatment begins within 6 weeks of the last day of induction chemotherapy administration.
  • Arm A: Patients receive bevacizumab IV over 30-90 minutes on day 1.
  • Arm B: Patients receive pemetrexed disodium IV over 10 minutes on day 1.
  • Arm C: Patients receive bevacizumab as in arm A and pemetrexed as in arm B. In all arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Some patients undergo blood sample collection at baseline and periodically during study for correlative studies.

After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 2-5 years.

Conditions
Lung Cancer
Being tested
Paclitaxel, Carboplatin, Bevacizumab, Pemetrexed Disodium Heptahydrate
Keywords
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Also called Taxol, NSC 673089

    Given IV

  • CarboplatinDrug

    Also called carboplatin for injection or platinum diamine [1,1-cyclobutane-decarbozxylate (2-0,0')-,(SP-4-2)]

    Given IV

  • BevacizumabBiological

    Also called NSC 704865, RhuMAb VEGF, Recombinant Humanized Monoclonal Anti-VEGF Antibody

    Given IV

  • Pemetrexed Disodium HeptahydrateDrug

    Also called L-Glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-, disodium salt, heptahydrate

    Given IV

Study groups in NCT01107626
Study groupRoleWhat they receive
Arm A (Induction then Maintenance with Bevacizumab)ExperimentalInduction Therapy: Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Maintenance Therapy: Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm A receive bevacizumab IV over 30-90 minutes on day 1 of every cycle until progression or unacceptable toxicity.
Receives: Drug: Paclitaxel; Drug: Carboplatin; Biological: Bevacizumab
Arm B (Induction then Maintenance with Pemetrexed)ExperimentalInduction Therapy: Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Maintenance Therapy: Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm B receive pemetrexed IV over 10 minutes on day 1 of every cycle until progression or unacceptable toxicity.
Receives: Drug: Paclitaxel; Drug: Carboplatin; Biological: Bevacizumab; Drug: Pemetrexed Disodium Heptahydrate
Arm C (Induction then Maintenance with Bevacizumab & Pemetrexed)ExperimentalInduction Therapy: Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Maintenance Therapy: Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Patients in arm C receive bevacizumab as in arm A and pemetrexed as in arm B.
Receives: Drug: Paclitaxel; Drug: Carboplatin; Biological: Bevacizumab; Drug: Pemetrexed Disodium Heptahydrate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Overall survival is defined as the time from randomization to death or date last known alive.

    The primary analysis is among patients who were randomized to the maintenance therapy. Patients who received induction therapy only and did not participate in the randomization part of the study were not included in this analysis.

    Measured: Assessed every 6 weeks during induction therapy and every 3 cycles during maintenance therapy; after discontinuation of study therapy, assessed every 3 months for 2 years and every 6 months for years 3-5

Secondary outcomes (2)

  1. Progression-free Survival

    Progression-free survival is defined as the time from randomization to progression or death, whichever occurs first. Progression is evaluated based on RECIST criteria and defined as appearance of one or more new lesions, unequivocal progression of existing non-target lesions, or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on current step. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

    The primary analysis is among patients who were randomized to the maintenance therapy. Patients who received induction therapy only and did not participate in the randomization part of the study were not included in this analysis.

    Measured: Assessed every 6 weeks during induction therapy and every 3 cycles during maintenance therapy; after discontinuation of study therapy, assessed every 3 months for 2 years and every 6 months for years 3-5

  2. Response Rate

    Response is evaluated based on RECIST criteria v1.1 and defined as either complete response or partial response. Complete response is defined as disappearance of all lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the current step's baseline sum diameters.

    The primary analysis is among patients who were randomized to the maintenance therapy. Patients who received induction therapy only and did not participate in the randomization part of the study were not included in this analysis.

    Measured: Assessed every 6 weeks during induction therapy and every 3 cycles during maintenance therapy; after discontinuation of study therapy, assessed every 3 months for 2 years and every 6 months for years 3-5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2010 (estimated)
  2. Study start25 Oct 2010
  3. Primary completion31 Jan 2019
  4. Study completion17 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,516 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01107626
Sponsor's protocol ID
E5508
Other IDs
NCT01107626
Status last verified
Jun 2023
First submitted
20 Apr 2010
Last updated
7 Jul 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.

Publications

  • Ramalingam SS, Dahlberg SE, Belani CP, Saltzman JN, Pennell NA, Nambudiri GS, McCann JC, Winegarden JD, Kassem MA, Mohamed MK, Rothman JM, Lyss AP, Horn L, Stinchcombe TE, Schiller JH. Pemetrexed, Bevacizumab, or the Combination As Maintenance Therapy for Advanced Nonsquamous Non-Small-Cell Lung Cancer: ECOG-ACRIN 5508. J Clin Oncol. 2019 Sep 10;37(26):2360-2367. doi: 10.1200/JCO.19.01006. Epub 2019 Jul 30.

    PubMed 31361535

  • Wang Y, Sun Z, Sridhar A, Ramalingam SS, Wakelee HA, Gerber DE. Participation in lung cancer biospecimen studies: an analysis of the ECOG-ACRIN phase 3 E1505 and E5508 clinical trials. Lung Cancer. 2026 Apr;214:109304. doi: 10.1016/j.lungcan.2026.109304. Epub 2026 Feb 7.

    PubMed 41666849

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Paclitaxel, Carboplatin and Bevacizumab in people with Lung Cancer, run by ECOG-ACRIN Cancer Research Group at 434 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 434 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Assessed every 6 weeks during induction therapy and every 3 cycles during maintenance therapy; after discontinuation of study therapy, assessed every 3 months for 2 years and every 6 months for years 3-5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01107626, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in