Trial record 1 of 1 for:    N0723
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Pemetrexed or Erlotinib as Second-Line Therapy in Treating Patients With Advanced Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Southwest Oncology Group
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00738881
First received: August 20, 2008
Last updated: January 14, 2013
Last verified: November 2012
  Purpose

This randomized phase III trial is studying pemetrexed to see how well it works compared with erlotinib when given as second-line therapy in treating patients with advanced non-small cell lung cancer. Pemetrexed and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pemetrexed is more effective than erlotinib in treating advanced non-small cell lung cancer


Condition Intervention Phase
Recurrent Non-small Cell Lung Cancer
Stage IIIA Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Drug: erlotinib hydrochloride
Drug: pemetrexed disodium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Biomarker Validation Study of Second-line Therapy in Patients With Advanced Non- Small Cell Lung Cancer (NSCLC) Randomized to Pemetrexed Versus Erlotinib

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Time from randomization to the first date of documented disease progression or death, assessed up to 5 years ] [ Designated as safety issue: No ]
    Estimated using the method of Kaplan-Meier survival curves and a 1-sided stratified log rank test [accounting for all the stratification factors except FISH status and cooperative group] will be used to compare PFS between the erlotinib and pemetrexed arms within the FISH(+) and FISH(-) subgroups. Cox proportional hazards model (including time varying coefficients as necessary) will be used to assess whether the distribution of PFS times differ with respect to treatment regimen after having adjusted for the stratification factors as well as other potential prognostic and treatment covariates.


Secondary Outcome Measures:
  • Time to treatment failure [ Time Frame: The time from date of randomization to the date at which the patient is removed from the treatment, assessed up to 5 years ] [ Designated as safety issue: No ]
    The distribution of all time to event data will be estimated using the method of Kaplan-Meier survival curves. Cox proportional hazards model (including time varying coefficients as necessary) will be used to assess potential differences in time to event outcomes after adjusting for the stratification factors and other potential prognostic and treatment covariates for these secondary endpoints.

  • Overall survival [ Time Frame: Time from randomization to time of death from any cause, assessed up to 5 years ] [ Designated as safety issue: No ]
    Will be estimated using the method of Kaplan-Meier survival curves. A 1-sided stratified log rank test [accounting for all the stratification factors except FISH status and cooperative group] will be used to compare overall survival between the erlotinib and pemetrexed arms within the FISH(+) and FISH(-) subgroups, compare overall and progression free survival between the erlotinib and pemetrexed arms within the subgroups defined on the basis of the EGFR expression by IHC, and EGFR gene mutation status (MUT). Cox proportional hazards model will be used to assess potential differences.

  • Confirmed response rate defined as complete response (CR) or a partial response (PR) per RECIST [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease. The proportion of patients with confirmed CR and PR will be computed within each treatment arm and exact binomial confidence intervals for the true proportion computed. Chi-square test and Fisher's exact test will be used to compare the response rates between the treatment arms within the subgroups defined by FISH status, IHC, and MUT.

  • Number and severity of adverse events (overall and within each arm) per NCI CTC Version 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    Will be recorded for each patient and frequency tables will be reviewed to determine the overall patterns. Will be tabulated and summarized within the subgroups defined by FISH status, IHC, and MUT. Grade 3+ adverse events will be similarly described and summarized separately. Overall toxicity incidence will be summarized using frequency distributions, graphical techniques and other descriptive measures. Chi-square test and Fisher's exact test will be used to formally compare the differences in adverse event profiles between the treatment arms within the different subgroups.


Estimated Enrollment: 1196
Study Start Date: October 2008
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: erlotinib hydrochloride
Given orally
Other Names:
  • CP-358,774
  • erlotinib
  • OSI-774
Experimental: Arm II
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: pemetrexed disodium
Given IV
Other Names:
  • ALIMTA
  • LY231514
  • MTA

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed non-small cell lung cancer (NSCLC), either oninitial diagnosis or at the time of disease recurrence/progression

    • Mixed histology allowed if all components are consistent with NSCLC
  • Recurrent or progressive disease
  • Measurable disease, defined as at least one lesion whose longest diameter can be accurately measured as ≥ 2.0 cm by conventional techniques or as ≥ 1.0 cm by spiral CT scan

    • Measurable disease must be outside of any previously irradiated treatment field(s) unless there is disease progression or recurrence within the irradiated field(s)
    • No nonmeasurable disease only, defined as any of the following:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
      • Abdominal masses not confirmed and followed by imaging techniques
      • Cystic lesions
      • Single disease site in prior radiotherapy field
  • Tumor tissue samples must be available and adequate for epidermal growth factor receptor (EGFR) evaluation by FISH
  • Previously treated with only one cytotoxic chemotherapy regimen for advanced disease

    • Neoadjuvant/adjuvant cytotoxic chemotherapy administered< 12 months (from date chemotherapy was started) prior to study entry will be counted as one prior treatment
    • Neoadjuvant/adjuvant chemotherapy administered ≥ 12 months prior to study entry and use of targeted agents (e.g., monoclonal antibodies) will not be counted as one prior treatment
  • No symptomatic serosal effusion (≥ grade 2 dyspnea as measured by CTCAE v3.0) that is not amenable to drainage
  • No brain metastasis, unless the following criteria are met:

    • Brain metastasis is stable and has been previously treated with either whole-brain radiotherapy or gamma-knife surgery
    • More than 14 days since prior steroid treatment
  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • Total bilirubin normal (ULN) OR direct bilirubinnormal
  • AST and ALT ≤ 2.5 times ULN
  • INR ≤ 1.5
  • Creatinine clearance ≥ 45 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to take folic acid, vitamin B_12 supplementation, and dexamethasone
  • No known HIV positivity
  • No clinically significant infection
  • No impaired gastrointestinal (GI) function, inability to swallow pills in the absence of a feeding tube, or GI disease that may significantly alter absorption of oral medications (e.g., ulcerative disease, uncontrolled nausea and vomiting, malabsorption syndromes, or bowel obstruction)
  • No serious condition that, in the opinion of the investigator, would preclude the patient's ability to complete the study therapy or increase the risk for serious adverse events
  • No other invasive malignant solid tumor or hematologic malignancy, except for any of the following:

    • Prior carcinoma in situ, regardless of organ involvement, or nonmelanoma cutaneous carcinoma that was definitively treated ≥ 3 years ago with no subsequent evidence of recurrence
    • Other prior malignancy diagnosed and definitively treated ≥ 5 years ago with no subsequent evidence of recurrence

      • Prior breast cancer that was definitively treated > 5 years ago allowed provided patient is not receiving aromatase inhibitors
      • Prio rlow-grade (Gleason score ≤ 6) localized prostate cancer that was diagnosed < 3 years ago allowed

        • Concurrent medications to maintain disease remission allowed
  • No concurrent severe and/or uncontrolled medical condition, including any of the following:

    • Angina pectoris
    • Congestive heart failure within the past 3 months, unless ejection fraction > 40%
    • Myocardial infarction within the past 6 months
    • Cardiac arrhythmia
    • Diabetes mellitus
    • Hypertension
    • Any other severe underlying disease that, in the judgment of the investigator, would preclude study entry
  • No respiratory symptoms > CTCAE grade 1
  • No significant traumatic injury within the past 4 weeks
  • No concurrent prophylactic colony-stimulating factors
  • Recovered from prior radiotherapy, except for alopecia
  • No prior radiotherapy to > 25% of bone marrow
  • No prior EGFR tyrosine kinase inhibitors or pemetrexed disodium
  • More than 3 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas)
  • More than 2 weeks since prior immunotherapy, gene therapy, or other biologic therapy
  • More than 2 weeks since prior limited-field radiotherapy (4 weeks for full-field radiotherapy)
  • More than 2 weeks since prior minor surgery*
  • More than 4 weeks since prior major surgery (i.e., laparotomy)* or open biopsy
  • More than 4 weeks since prior hormonal therapy
  • More than 4 weeks since prior and no other concurrent ancillary therapy considered investigational (i.e., utilized for a non-FDA-approved indication and in the context of a research investigation)
  • No aspirin dose ≥ 1.3 g/day for ≥ 10days before, during, and for ≥ 10 days after treatment with pemetrexed disodium
  • No other concurrent chemotherapy, immunotherapy, hormonal therapy, or radiotherapy

    • Radiotherapy for symptom palliation (e.g., painful pre-existing bony metastasis) allowed
  • No other concurrent anticancer therapy
  • No concurrent major surgery
  • No concurrent antiretroviral therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738881

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Locations
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, Arkansas
Sparks Regional Medical Center
Fort Smith, Arkansas, United States, 72901
United States, California
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States, 94531
Kaiser Permanente, Fremont
Fremont, California, United States, 94538
Kaiser Permanente, Hayward
Hayward, California, United States, 94545
Fremont - Rideout Cancer Center
Marysville, California, United States, 95901
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Valley Care Health System - Pleasanton
Pleasanton, California, United States, 94588
Kaiser Permanente-Redwood City
Redwood City, California, United States, 94063
Kaiser Permanente-Richmond
Richmond, California, United States, 94801
Kaiser Permanente-Roseville
Roseville, California, United States, 95661
Kaiser Permanente-South Sacramento
Sacramento, California, United States, 95823
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Kaiser Permanente - Sacramento
Sacramento, California, United States, 95825
Kaiser Permanente-San Francisco
San Francisco, California, United States, 94115
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States, 95119
Kaiser Permanente-San Rafael
San Rafael, California, United States, 94903
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States, 95403
Kaiser Permanente-South San Francisco
South San Francisco, California, United States, 94080
Kaiser Permanente-Stockton
Stockton, California, United States, 95210
Tahoe Forest Cancer Center
Truckee, California, United States, 96161
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, United States, 95688
Kaiser Permanente-Vallejo
Vallejo, California, United States, 94589
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States, 94596
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Saint Anthony Central Hospital
Denver, Colorado, United States, 80204
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Rose Medical Center
Denver, Colorado, United States, 80220
Exempla Saint Joseph Hospital
Denver, Colorado, United States, 80218
Colorado Cancer Research Program CCOP
Denver, Colorado, United States, 80224-2522
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Swedish Medical Center
Englewood, Colorado, United States, 80110
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Bristol Hospital
Bristol, Connecticut, United States, 06011
Middlesex Hospital
Middletown, Connecticut, United States, 06457
United States, Florida
Lynn Regional Cancer Center - West
Boca Raton, Florida, United States, 33428
Boca Raton Comprehensive Cancer Center
Boca Raton, Florida, United States, 33486
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
United States, Illinois
Hematology Oncology Associates-Berwyn
Berwyn, Illinois, United States, 60402
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare-Bloomington
Bloomington%, Illinois, United States, 61701
Graham Hospital Association
Canton, Illinois, United States, 61520
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Memorial Hospital
Carthage, Illinois, United States, 62321
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
Northwestern University
Chicago, Illinois, United States, 60611
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Eureka Hospital
Eureka, Illinois, United States, 61530
Illinois CancerCare-Cottage
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Galesburg Clinic
Galesburg, Illinois, United States, 61401
Mason District Hospital
Havana, Illinois, United States, 62644
Illinois CancerCare-Havana
Havana, Illinois, United States, 62644
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, United States, 60035
Hopedale Medical Complex - Hospital
Hopedale, Illinois, United States, 61747
Midwest Center for Hematology Oncology
Joliet, Illinois, United States, 60432
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
North Shore Hematology Oncology
Libertyville, Illinois, United States, 60048
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Mcdonough District Hospital
Macomb, Illinois, United States, 61455
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States, 61462
Holy Family Medical Center
Monmouth, Illinois, United States, 61462
DuPage Medical Group-Ogden
Naperville, Illinois, United States, 60563
Illinois Cancer Specialists-Niles
Niles, Illinois, United States, 60714
Bromenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Illinois CancerCare-Community Cancer Center
Normal, Illinois, United States, 61761
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States, 61350
Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Pekin Hospital
Pekin, Illinois, United States, 61554
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61603
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Illinois Oncology Research Association CCOP
Peoria, Illinois, United States, 61615
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Proctor Hospital
Peoria, Illinois, United States, 61614
OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC
Peoria, Illinois, United States, 61615-7827
Illinois Valley Hospital
Peru, Illinois, United States, 61354
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, United States, 60076
Saint Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, United States, 61362
Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
United States, Indiana
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, United States, 46107
Reid Hospital and Health Care Services
Richmond, Indiana, United States, 47374
United States, Iowa
McFarland Clinic
Ames, Iowa, United States, 50010
Hematology Oncology Associates-Quad Cities
Bettendorf, Iowa, United States, 52722
Oncology Associates
Cedar Rapids, Iowa, United States, 52403
Cedar Rapids Oncology Association
Cedar Rapids, Iowa, United States, 52403
Mercy Hospital
Cedar Rapids, Iowa, United States, 52403
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Genesis Medical Center - West Campus
Davenport, Iowa, United States, 52804
Genesis Medical Center - East Campus
Davenport, Iowa, United States, 52803
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates
Des Moines, Iowa, United States, 50314
Mercy Capitol
Des Moines, Iowa, United States, 50307
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Siouxland Hematology - Oncology Associates
Sioux City, Iowa, United States, 51101
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Covenant Medical Center
Waterloo, Iowa, United States, 50702
United States, Kansas
Hospital District Sixth of Harper County
Anthony, Kansas, United States, 67003
Saint Luke's South Hospital
Overland Park, Kansas, United States, 66213
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Shawnee Mission Medical Center
Shawnee Mission, Kansas, United States, 66204
Stormont-Vail Regional Health Center
Topeka, Kansas, United States, 66604
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
The Memorial Hospital at Easton
Easton, Maryland, United States, 21601
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Caritas Saint Elizabeth's Medical Center
Brighton, Massachusetts, United States, 02135-2997
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
United States, Michigan
Hickman Cancer Center
Adrian, Michigan, United States, 49221
Bixby Medical Center
Adrian, Michigan, United States, 49221
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Mecosta County Medical Center
Big Rapids, Michigan, United States, 49307
Oakwood Hospital
Dearborn, Michigan, United States, 48123
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Hurley Medical Center
Flint, Michigan, United States, 48502
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Allegiance Health
Jackson, Michigan, United States, 49201
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Mercy Memorial Hospital
Monroe, Michigan, United States, 48162
Mercy Health Partners-Mercy Campus
Muskegon, Michigan, United States, 49443
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Munson Medical Center
Traverse City, Michigan, United States, 49684
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
Metro Health Hospital
Wyoming, Michigan, United States, 49519
United States, Minnesota
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
Essentia Health Duluth Clinic CCOP
Duluth, Minnesota, United States, 55805
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Meeker County Memorial Hospital
Litchfield, Minnesota, United States, 55355
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Mayo Clinic
Rochester, Minnesota, United States, 55905
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
United States, Missouri
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
Saint Joseph Health Center
Kansas City, Missouri, United States, 64114
Truman Medical Center
Kansas City, Missouri, United States, 64108
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Research Medical Center
Kansas City, Missouri, United States, 64132
Liberty Radiation Oncology Clinic
Kansas City, Missouri, United States, 64116
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Liberty Hospital
Liberty, Missouri, United States, 64068
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Center for Cancer Care and Research
Saint Louis, Missouri, United States, 63141
Saint Louis University Hospital
Saint Louis, Missouri, United States, 63110
United States, Montana
Montana Cancer Consortium CCOP
Billings, Montana, United States, 59101
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Billings Clinic
Billings, Montana, United States, 59107-7000
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, United States, 59102
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Great Falls Clinic
Great Falls, Montana, United States, 59405
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, United States, 59405
Northern Montana Hospital
Havre, Montana, United States, 59501
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Glacier Oncology PLLC
Kalispell, Montana, United States, 59901
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
Montana Cancer Specialists
Missoula, Montana, United States, 59802
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
Community Medical Hospital
Missoula, Montana, United States, 59801
United States, Nebraska
Good Samaritan Hospital
Kearney, Nebraska, United States, 68847
United States, New Jersey
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, United States, 07018-1095
Hunterdon Medical Center
Flemington, New Jersey, United States, 08822
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, United States, 08060
Riverview Medical Center/Booker Cancer Center
Red Bank, New Jersey, United States, 07701
Virtua West Jersey Hospital Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
University of Rochester
Rochester, New York, United States, 14642
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
Syracuse Veterans Administration Medical Center
Syracuse, New York, United States, 13210
United States, North Carolina
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
United States, North Dakota
Medcenter One Health Systems
Bismarck, North Dakota, United States, 58501
Saint Alexius Medical Center
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic
Bismarck, North Dakota, United States, 58501
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
Altru Cancer Center
Grand Forks, North Dakota, United States, 58201
United States, Ohio
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
North Coast Cancer Care-Clyde
Clyde, Ohio, United States, 43410
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Grandview Hospital
Dayton, Ohio, United States, 45405
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Dayton CCOP
Dayton, Ohio, United States, 45420
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Hematology Oncology Center Incorporated
Elyria, Ohio, United States, 44035
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Kettering Medical Center
Kettering, Ohio, United States, 45429
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States, 43537
Saint Luke's Hospital
Maumee, Ohio, United States, 43537
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537-1839
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States, 43616
Saint Charles Hospital
Oregon, Ohio, United States, 43616
North Coast Cancer Care
Sandusky, Ohio, United States, 44870
Flower Hospital
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
University of Toledo
Toledo, Ohio, United States, 43614
Mercy Cancer Center at Saint Anne Mercy Hospital
Toledo, Ohio, United States, 43623
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
The Toledo Hospital
Toledo, Ohio, United States, 43606
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States, 43617
Toledo Clinic
Toledo, Ohio, United States, 43623
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Clinton Memorial Hospital
Wilmington, Ohio, United States, 45177
Greene Memorial Hospital
Xenia, Ohio, United States, 45385
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Geisinger Medical Center-Cancer Center Hazelton
Hazleton, Pennsylvania, United States, 18201
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Mercy Hospital
Scranton, Pennsylvania, United States, 18501
Scranton Hematology Oncology
Scranton, Pennsylvania, United States, 18510
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18711
United States, South Carolina
AnMed Health Hospital
Anderson, South Carolina, United States, 29621
Upstate Carolina CCOP
Spartanburg, South Carolina, United States, 29303
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States, 22401
Memorial Hospital Of Martinsville
Martinsville, Virginia, United States, 24115
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Sponsors and Collaborators
Southwest Oncology Group
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Investigators
Principal Investigator: Alex Adjei North Central Cancer Treatment Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00738881     History of Changes
Other Study ID Numbers: NCI-2009-00663, N0723, U10CA025224, CDR0000612010
Study First Received: August 20, 2008
Last Updated: January 14, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib
Pemetrexed
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents
Therapeutic Uses
Folic Acid Antagonists

ClinicalTrials.gov processed this record on September 15, 2014