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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 Center Tucson, Arizona  85724
Morristown Memorial Hospital Morristown, New Jersey  07962-1956
Halifax Medical Center Daytona Beach, Florida  32114
Northeast Medical Center Concord, North Carolina  28025
Akron General Medical Center Akron, Ohio  44302
Sutter Cancer Center Sacramento, California  95816
Baystate Medical Center Springfield, Massachusetts  01199
William Beaumont Hospital Royal Oak, Michigan  48073
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Overlook Hospital Summit, New Jersey  07902-0220
MetroHealth Medical Center Cleveland, Ohio  44109
Wilford Hall Medical Center Lackland Air Force Base, Texas  78236-5300
All Saints Cancer Center Racine, Wisconsin  53405
Summa Health System Akron, Ohio  44312
Big Sky Oncology Great Falls, Montana  59405
Jackson Memorial Hospital Miami, Florida  33136
Front Range Cancer Specialists Fort Collins, Colorado  80528
Ellis Fischel Cancer Center Columbia, Missouri  65203
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Pacific Shores Medical Group Long Beach, California  90813
Community Hospital Munster, Indiana  46321
Kinston Medical Specialists Kinston, North Carolina  28501
Presbyterian Hospital Charlotte, North Carolina  28233-3549
Center for Hematology-Oncology Boca Raton, Florida  33486
La Grange Oncology Associates La Grange, Illinois  60525
Erlanger Health Systems Chattanooga, Tennessee  37403
University of Pennsylvania Philadelphia, Pennsylvania  19104
Mercy General Hospital Sacramento, California  95819
Willis-Knighton Cancer Center Shreveport, Louisiana  71103-3
Nebraska Methodist Hospital Omaha, Nebraska  68114
Cascade Cancer Center Kirkland, Washington  98034-3013
Charleston Cancer Center Charleston, South Carolina  29406
Dana Farber Cancer Institute Boston, Massachusetts  02115
Riverside Methodist Hospital Columbus, Ohio  43214
Naval Medical Center San Diego, California  92134
University of Louisville Louisville, Kentucky  40202
Consultants in Blood Disorders Louisville, Kentucky  40207
Sarah Cannon Cancer Center Nashville, Tennessee  37203
Texas Cancer Associates Dallas, Texas  75231
NYU Medical Center New York, New York  10016
Mayo Clinic Scottsdale, Arizona  
Kaiser Permanente Sacramento, California  
Cancer Care Associates Fresno, California  93720
Lagrange Oncology Associates La Grange, Illinois  60525
Gabrail Cancer Center Canton, Ohio  44718
Jersey Shore Medical Center Neptune, New Jersey  07754
Frederick Memorial Hospital Frederick, Maryland  21701
Spectrum Health Grand Rapids, Michigan  49503
Peninsula Cancer Institute Newport News, Virginia  23601
Montana Cancer Specialists Missoula, Montana  59807-7877
Mile High Oncology Denver, Colorado  80210
The Jones Clinic Germantown, Tennessee  38138
West Suburban Cancer Center River Forest, Illinois  60305
Billings Clinic Billings, Montana  59107-7000
Hunterdon Medical Center Flemington, New Jersey  08822
Mountainside Hospital Montclair, New Jersey  07042
Ephrata Cancer Center Ephrata, Pennsylvania  17522
Scranton Hematology Oncology Scranton, Pennsylvania  18510
West Virginia University Morgantown, West Virginia  26506
Freeman Cancer Institute Joplin, Missouri  64804
Florida Wellcare Alliance Inverness, Florida  34452
Carolina BioOncology Institute Huntersville, North Carolina  28078
Baptist Cancer Institute Jacksonville, Florida  32207
JPS Center for Cancer Care Fort Worth, Texas  76104
Coastal Bend Cancer Center Corpus Christi, Texas  78404
Oncology Alliance Milwaukee, Wisconsin  53215
Providence Medical Group Terre Haute, Indiana  47802
Aultman Hospital Canton, Ohio  44710
Arch Medical Services St. Louis, Missouri  63141
Vanderbilt University Medical Nashville, Tennessee  37232
Sacred Heart Medical Onc Group Mobile, Alabama  36608
St. Edward Mercy Medical Ctr Ft Smith, Arizona  72917
Central Hem/Onc Medical Group Alhambra, California  91801
Comp Blood & Cancer Center Bakersfield, California  93309
South Bay Oncology Campbell, California  95008
Bay Area Cancer Research Grp Concord, California  94598
Pacific Onc & Hem Assoc Encinitas, California  92024
Pacific Coast Hem/Onc Fountain Valley, California  92708
St. Jude Heritage Med Group Fullerton, California  92835
Ronald H. Yanagihara Gilroy, California  95020
Glendale Adventist Medical Ctr Glendale, California  91206
Scipps Clinic La Jolla, California  92037-1027
Loma Linda Univ Medical Center Loma Linda, California  92354
Kenmar Research Institute LLC Los Angeles, California  90057
UCLA Medical Ctr Los Angeles, California  90095
Sutter Gould Med Foundation Modesto, California  95355
North Valley Hem Onc Med Grp Northridge, California  91325
Medical Oncology Care Assoc Orange, California  92868
Hem Onc Med Grp Orange Cty Orange, California  92868
Ventura Co Hem-Onc Specialists Oxnard, California  93030
Wilshire Oncology Medical Grp Pomona, California  91767
Los Palos Oncology & Hem Salinas, California  93901
Pacific Hematology Oncology San Francisco, California  94115
Kaiser Permanente Santa Teresa San Jose, California  95119
Sansum Medical Clinic, Inc. Santa Barbara, California  93105
Santa Barbara Hem Onc Med Grp Santa Barbara, California  93105
Central Coast Medical Oncology Santa Maria, California  93454
The Angeles Clinic Santa Monica, California  90404
Redwood Regional Med Grp Santa Rosa, California  95403
Washington Onc Hem Center PC Washington, District of Columbia  20037
Mid-Florida Hem Oncology Ctr Orange City, Florida  32763
Integrated Comm Onc Network Orange Park, Florida  32073
Hematology Onc Treasure Coast Port Saint Lucie, Florida  34952
Phoebe Putney Cancer Center Albany, Georgia  31701
Northeast Georgia Cancer Care Athens, Georgia  30607
Suburban Hem-Onc Associates Lawrenceville, Georgia  30045
Northwest Georgia Onc Centers Marietta, Georgia  30060
Chicagoland Hematology Onc Arlington Heights, Illinois  60005
Weiss-Strauss Oncology Center Chicago, Illinois  60640
Associates in Medical Oncology Oak Lawn, Illinois  60453
Onc Hem Assoc of Central IL Peoria, Illinois  61615
OSF St. Anthony Med Ctr Rockford, Illinois  61108
Hematology Oncology Associates Bettendorf, Iowa  52722
Siouxland Hem-Onc Assoc LLP Sioux City, Iowa  51101
Covenant Clinic Waterloo, Iowa  50702
Gajera & Patel, PLLC Hopkinsville, Kentucky  42240
Kentuckiana Cancer Center Louisville, Kentucky  40202
Owensboro Medical Health Sys Owensboro, Kentucky  42303
H&J Weinberg Cancer Institute Baltimore, Maryland  21237
Oncology Hematology Associates Clinton, Maryland  20735
Maryland Oncology/Hema PA Columbia, Maryland  21044
Caritas St. Elizabeth Med Ctr Boston, Massachusetts  02135
Lahey Clinic Med Ctr Burlington, Massachusetts  01805
Metrowest Cancer Center Framingham, Massachusetts  01702
Kalamazoo Hem & Onc Kalamazoo, Michigan  49048
Marquette General Health Sys Marquette, Michigan  49855
Virginia Piper Cancer Inst Minneapolis, Minnesota  55407
St. Louis Univ Care Center Saint Louis, Missouri  63117
Missouri Cancer Center, PC St Charles, Missouri  63301
NE Hematology Oncology, PC Lincoln, Nebraska  68506
Comp Cancer Centers of Nevada Las Vegas, Nevada  89109
Ctr for Cancer & Hem Disease Cherry Hill, New Jersey  08003
Forte, Attas & Schleider Englewood, New Jersey  07631
Central State Medical Center Freehold, New Jersey  07728
St. Barnabas Health Care Sys Livingston, New Jersey  07039
Hematology Oncology Assoc SJ Mount Holly, New Jersey  08060
The Valley Hospital Paramus, New Jersey  07652
Holy Name Hospital Teaneck, New Jersey  07666
San Juan Onco Assoc Farmington, New Mexico  87401
Zale P Bernstein MD - PP Buffalo, New York  14215
Bassett Cancer Center Cooperstown, New York  13326
Adriondack Cancer Care Glen Falls, New York  12801
BRANY Great Neck, New York  11021
Queens Cancer Center Jamaica, New York  11432
Crystal Run Health Care Middletown, New York  10941
Mem Sloan Kettering Cancer Ctr New York, New York  10021
SUNY Upstate Syracuse, New York  13210
Moses Cone Reg Cncr Ctr Greensboro, North Carolina  27403
Emerywood Hematology Oncology High Point, North Carolina  27262
Beaufort County Hospital Washington, North Carolina  27889
Onc/Hem Care Clin Trials LLC Cincinnati, Ohio  45242
Mid Ohio Onc Hematology Inc Columbus, Ohio  43213
Dayton Clinical Oncology Prog Dayton, Ohio  45429
Ohio Cancer Specialists Mansfield, Ohio  44907
Signal Point Hem/Oncology Inc Middletown, Ohio  45042
Toledo Community Hospital Toledo, Ohio  43623
Forum Health Cancer Care Ctr Youngstown, Ohio  44501
Providence Portland Med Center Portland, Oregon  97213
Armstrong County Memorial Hosp Kittanning, Pennsylvania  16201
Hem Onc Assoc Phys Lancaster Lancaster, Pennsylvania  17604
Assoc in Hematology Oncology Upland, Pennsylvania  19013
Lankenau Medical Office Bldg Wynnewood, Pennsylvania  19096
Palmetto Hematology Oncology Spartanburg, South Carolina  29303
Jackson-Madsion County Hosp Jackson, Tennessee  38301
Clopton Clinic Memphis, Tennessee  38138
Lone Star Oncology Consultants Austin, Texas  78759
Texas Hematology Oncology Dallas, Texas  75234
Univ of Texas Medical Branch Galveston, Texas  77555
SW Vermont Healthcare Onc Asoc Bennington, Vermont  05201
Vermont Ctr Cancer Medicine Colchester, Vermont  05446
Community Cancer Center Rutland, Vermont  05701
SW Virginia Hem Onc Roanoke, Virginia  24014
Northwest Medical Specialists Tacoma, Washington  98405
Univ Physicians Internal Med Huntington, West Virginia  25701
Dean Clinic Madison, Wisconsin  53715
Medical Consultants LTD Milwaukee, Wisconsin  53215