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A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Trial Comparing Bevacizumab Therapy With or Without Erlotinib After Completion of Chemotherapy With Bevacizumab for the First-Line Treatment of Locally Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Trial Comparing Bevacizumab Therapy With or Without Erlotinib After Completion of Chemotherapy With Bevacizumab for the First-Line Treatment of Locally Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer


Inclusion Criteria:



- Signed Informed Consent Form

- Histologically or cytologically confirmed NSCLC

- Advanced NSCLC or recurrent disease

- INR no greater than 1.3 and aPTT no greater than upper limits of normal (ULN) within
28 days prior to enrollment for subjects not on low molecular weight heparin or
fondaparinux. Subjects on low molecular weight heparin or fondaparinux are not
required to meet INR or aPTT limits. Chronic full-dose anticoagulation with warfarin
is not permitted.

- 18 years of age or older

- For women of childbearing potential and sexually active men, use of an accepted and
effective method of contraception (hormonal or barrier methods, abstinence) prior to
enrollment and for the duration of the study

Exclusion Criteria:

- Prior systemic chemotherapy in the metastatic setting

- Treatment with an investigational or marketed agent that acts by either EGFR
inhibition or anti-angiogenesis mechanisms

- Pregnancy or lactation

- Any other medical condition, including mental illness or substance abuse, deemed by
the clinician to be likely to interfere with a subject's ability to provide informed
consent, cooperate, and participate in the study, or to interfere with the
interpretation of the results

- Active infection or a fever within 3 days of enrollment

- Active malignancy other than lung cancer

- Radiation therapy to sites other than whole brain within 14 days prior to enrollment

- History of gross hemoptysis within 3 months prior to enrollment

- Known hypersensitivity to any of the components of cytotoxic chemotherapy
combinations, bevacizumab, or tyrosine kinase inhibitors

- Inadequately controlled hypertension

- Unstable angina or New York Heart Association Grade II or greater CHF

- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6
months prior to enrollment

- History of myocardial infarction within 6 months prior to enrollment

- History of stroke within 6 months prior to enrollment

- Symptomatic peripheral vascular disease within 6 months prior to enrollment

- Evidence of bleeding diathesis or coagulopathy

- Serious, non-healing wound, ulcer, or bone fracture

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to enrollment; anticipation of need for major surgical procedure during the
course of the study

- Current, recent, or planned participation in an experimental drug study other than
this Genentech-sponsored bevacizumab/erlotinib study

- Progressive neurologic symptoms in subjects with a history of brain metastases

- History of significant vascular disease (e.g., aortic aneurysm)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Post-chemo phase

Safety Issue:

No

Principal Investigator

Donald Strickland, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

AVF3671g

NCT ID:

NCT00257608

Start Date:

January 2006

Completion Date:

December 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • Lung Cancer
  • ATLAS
  • Avastin
  • Tarceva
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Morristown Memorial HospitalMorristown, New Jersey  07962-1956
Halifax Medical CenterDaytona Beach, Florida  32114
Northeast Medical CenterConcord, North Carolina  28025
Akron General Medical CenterAkron, Ohio  44302
Sutter Cancer CenterSacramento, California  95816
Baystate Medical CenterSpringfield, Massachusetts  01199
William Beaumont HospitalRoyal Oak, Michigan  48073
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Overlook HospitalSummit, New Jersey  07902-0220
MetroHealth Medical CenterCleveland, Ohio  44109
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
All Saints Cancer CenterRacine, Wisconsin  53405
Summa Health SystemAkron, Ohio  44312
Big Sky OncologyGreat Falls, Montana  59405
Jackson Memorial HospitalMiami, Florida  33136
Front Range Cancer SpecialistsFort Collins, Colorado  80528
Ellis Fischel Cancer CenterColumbia, Missouri  65203
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Pacific Shores Medical GroupLong Beach, California  90813
Community HospitalMunster, Indiana  46321
Kinston Medical SpecialistsKinston, North Carolina  28501
Presbyterian HospitalCharlotte, North Carolina  28233-3549
Center for Hematology-OncologyBoca Raton, Florida  33486
La Grange Oncology AssociatesLa Grange, Illinois  60525
Erlanger Health SystemsChattanooga, Tennessee  37403
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Mercy General HospitalSacramento, California  95819
Willis-Knighton Cancer CenterShreveport, Louisiana  71103-3
Nebraska Methodist HospitalOmaha, Nebraska  68114
Cascade Cancer CenterKirkland, Washington  98034-3013
Charleston Cancer CenterCharleston, South Carolina  29406
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Riverside Methodist HospitalColumbus, Ohio  43214
Naval Medical CenterSan Diego, California  92134
University of LouisvilleLouisville, Kentucky  40202
Consultants in Blood DisordersLouisville, Kentucky  40207
Sarah Cannon Cancer CenterNashville, Tennessee  37203
Texas Cancer AssociatesDallas, Texas  75231
NYU Medical CenterNew York, New York  10016
Mayo ClinicScottsdale, Arizona  
Kaiser PermanenteSacramento, California  
Cancer Care AssociatesFresno, California  93720
Lagrange Oncology AssociatesLa Grange, Illinois  60525
Gabrail Cancer CenterCanton, Ohio  44718
Jersey Shore Medical CenterNeptune, New Jersey  07754
Frederick Memorial HospitalFrederick, Maryland  21701
Spectrum HealthGrand Rapids, Michigan  49503
Peninsula Cancer InstituteNewport News, Virginia  23601
Montana Cancer SpecialistsMissoula, Montana  59807-7877
Mile High OncologyDenver, Colorado  80210
The Jones ClinicGermantown, Tennessee  38138
West Suburban Cancer CenterRiver Forest, Illinois  60305
Billings ClinicBillings, Montana  59107-7000
Hunterdon Medical CenterFlemington, New Jersey  08822
Mountainside HospitalMontclair, New Jersey  07042
Ephrata Cancer CenterEphrata, Pennsylvania  17522
Scranton Hematology OncologyScranton, Pennsylvania  18510
West Virginia UniversityMorgantown, West Virginia  26506
Freeman Cancer InstituteJoplin, Missouri  64804
Florida Wellcare AllianceInverness, Florida  34452
Carolina BioOncology InstituteHuntersville, North Carolina  28078
Baptist Cancer InstituteJacksonville, Florida  32207
JPS Center for Cancer CareFort Worth, Texas  76104
Coastal Bend Cancer CenterCorpus Christi, Texas  78404
Oncology AllianceMilwaukee, Wisconsin  53215
Providence Medical GroupTerre Haute, Indiana  47802
Aultman HospitalCanton, Ohio  44710
Arch Medical ServicesSt. Louis, Missouri  63141
Vanderbilt University MedicalNashville, Tennessee  37232
Sacred Heart Medical Onc GroupMobile, Alabama  36608
St. Edward Mercy Medical CtrFt Smith, Arizona  72917
Central Hem/Onc Medical GroupAlhambra, California  91801
Comp Blood & Cancer CenterBakersfield, California  93309
South Bay OncologyCampbell, California  95008
Bay Area Cancer Research GrpConcord, California  94598
Pacific Onc & Hem AssocEncinitas, California  92024
Pacific Coast Hem/OncFountain Valley, California  92708
St. Jude Heritage Med GroupFullerton, California  92835
Ronald H. YanagiharaGilroy, California  95020
Glendale Adventist Medical CtrGlendale, California  91206
Scipps ClinicLa Jolla, California  92037-1027
Loma Linda Univ Medical CenterLoma Linda, California  92354
Kenmar Research Institute LLCLos Angeles, California  90057
UCLA Medical CtrLos Angeles, California  90095
Sutter Gould Med FoundationModesto, California  95355
North Valley Hem Onc Med GrpNorthridge, California  91325
Medical Oncology Care AssocOrange, California  92868
Hem Onc Med Grp Orange CtyOrange, California  92868
Ventura Co Hem-Onc SpecialistsOxnard, California  93030
Wilshire Oncology Medical GrpPomona, California  91767
Los Palos Oncology & HemSalinas, California  93901
Pacific Hematology OncologySan Francisco, California  94115
Kaiser Permanente Santa TeresaSan Jose, California  95119
Sansum Medical Clinic, Inc.Santa Barbara, California  93105
Santa Barbara Hem Onc Med GrpSanta Barbara, California  93105
Central Coast Medical OncologySanta Maria, California  93454
The Angeles ClinicSanta Monica, California  90404
Redwood Regional Med GrpSanta Rosa, California  95403
Washington Onc Hem Center PCWashington, District of Columbia  20037
Mid-Florida Hem Oncology CtrOrange City, Florida  32763
Integrated Comm Onc NetworkOrange Park, Florida  32073
Hematology Onc Treasure CoastPort Saint Lucie, Florida  34952
Phoebe Putney Cancer CenterAlbany, Georgia  31701
Northeast Georgia Cancer CareAthens, Georgia  30607
Suburban Hem-Onc AssociatesLawrenceville, Georgia  30045
Northwest Georgia Onc CentersMarietta, Georgia  30060
Chicagoland Hematology OncArlington Heights, Illinois  60005
Weiss-Strauss Oncology CenterChicago, Illinois  60640
Associates in Medical OncologyOak Lawn, Illinois  60453
Onc Hem Assoc of Central ILPeoria, Illinois  61615
OSF St. Anthony Med CtrRockford, Illinois  61108
Hematology Oncology AssociatesBettendorf, Iowa  52722
Siouxland Hem-Onc Assoc LLPSioux City, Iowa  51101
Covenant ClinicWaterloo, Iowa  50702
Gajera & Patel, PLLCHopkinsville, Kentucky  42240
Kentuckiana Cancer CenterLouisville, Kentucky  40202
Owensboro Medical Health SysOwensboro, Kentucky  42303
H&J Weinberg Cancer InstituteBaltimore, Maryland  21237
Oncology Hematology AssociatesClinton, Maryland  20735
Maryland Oncology/Hema PAColumbia, Maryland  21044
Caritas St. Elizabeth Med CtrBoston, Massachusetts  02135
Lahey Clinic Med CtrBurlington, Massachusetts  01805
Metrowest Cancer CenterFramingham, Massachusetts  01702
Kalamazoo Hem & OncKalamazoo, Michigan  49048
Marquette General Health SysMarquette, Michigan  49855
Virginia Piper Cancer InstMinneapolis, Minnesota  55407
St. Louis Univ Care CenterSaint Louis, Missouri  63117
Missouri Cancer Center, PCSt Charles, Missouri  63301
NE Hematology Oncology, PCLincoln, Nebraska  68506
Comp Cancer Centers of NevadaLas Vegas, Nevada  89109
Ctr for Cancer & Hem DiseaseCherry Hill, New Jersey  08003
Forte, Attas & SchleiderEnglewood, New Jersey  07631
Central State Medical CenterFreehold, New Jersey  07728
St. Barnabas Health Care SysLivingston, New Jersey  07039
Hematology Oncology Assoc SJMount Holly, New Jersey  08060
The Valley HospitalParamus, New Jersey  07652
Holy Name HospitalTeaneck, New Jersey  07666
San Juan Onco AssocFarmington, New Mexico  87401
Zale P Bernstein MD - PPBuffalo, New York  14215
Bassett Cancer CenterCooperstown, New York  13326
Adriondack Cancer CareGlen Falls, New York  12801
BRANYGreat Neck, New York  11021
Queens Cancer CenterJamaica, New York  11432
Crystal Run Health CareMiddletown, New York  10941
Mem Sloan Kettering Cancer CtrNew York, New York  10021
SUNY UpstateSyracuse, New York  13210
Moses Cone Reg Cncr CtrGreensboro, North Carolina  27403
Emerywood Hematology OncologyHigh Point, North Carolina  27262
Beaufort County HospitalWashington, North Carolina  27889
Onc/Hem Care Clin Trials LLCCincinnati, Ohio  45242
Mid Ohio Onc Hematology IncColumbus, Ohio  43213
Dayton Clinical Oncology ProgDayton, Ohio  45429
Ohio Cancer SpecialistsMansfield, Ohio  44907
Signal Point Hem/Oncology IncMiddletown, Ohio  45042
Toledo Community HospitalToledo, Ohio  43623
Forum Health Cancer Care CtrYoungstown, Ohio  44501
Providence Portland Med CenterPortland, Oregon  97213
Armstrong County Memorial HospKittanning, Pennsylvania  16201
Hem Onc Assoc Phys LancasterLancaster, Pennsylvania  17604
Assoc in Hematology OncologyUpland, Pennsylvania  19013
Lankenau Medical Office BldgWynnewood, Pennsylvania  19096
Palmetto Hematology OncologySpartanburg, South Carolina  29303
Jackson-Madsion County HospJackson, Tennessee  38301
Clopton ClinicMemphis, Tennessee  38138
Lone Star Oncology ConsultantsAustin, Texas  78759
Texas Hematology OncologyDallas, Texas  75234
Univ of Texas Medical BranchGalveston, Texas  77555
SW Vermont Healthcare Onc AsocBennington, Vermont  05201
Vermont Ctr Cancer MedicineColchester, Vermont  05446
Community Cancer CenterRutland, Vermont  05701
SW Virginia Hem OncRoanoke, Virginia  24014
Northwest Medical SpecialistsTacoma, Washington  98405
Univ Physicians Internal MedHuntington, West Virginia  25701
Dean ClinicMadison, Wisconsin  53715
Medical Consultants LTDMilwaukee, Wisconsin  53215