AzTrials
AzTrials

Recurrent Non-Small Cell Lung CarcinomaPhase 3MARVELNCT00738881

Pemetrexed Disodium or Erlotinib Hydrochloride as Second-Line Therapy in Treating Patients With Advanced Non-small Cell Lung Cancer

A Phase 3 study testing Erlotinib Hydrochloride and Pemetrexed Disodium in people with Recurrent Non-Small Cell Lung Carcinoma and Stage IIIA Non-Small Cell Lung Cancer, run by National Cancer Institute (NCI) at 269 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This randomized phase III trial studies pemetrexed disodium to see how well it works compared with erlotinib hydrochloride as second-line therapy in treating patients with non-small cell lung cancer that has spread to other places in the body. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Erlotinib Hydrochloride and Pemetrexed Disodium
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
269 sitesin 2 countries
Study dates
Oct 2008to Dec 2014
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

  • Documented recurrence or disease progression of NSCLC
  • NSCLC must be confirmed by pathologic examination, either on initial diagnosis or disease recurrence/progression; mixed histology allowed if all components consistent with NSCLC
  • 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 computed tomography (CT); if spiral CT is used, it must be used for both pre- and post- treatment tumor assessments
  • Prior radiation therapy is permitted as long as:
  • Recovered from the toxic effects of radiation treatment before study entry, except for alopecia
  • =< 25% of bone marrow radiated
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  • Presence of measurable disease whether in-field disease progression/recurrence or disease outside the treatment fields of radiation port
  • Absolute neutrophil count (ANC) >= 1,500 uL
  • Platelet (PLT) >= 100,000 uL
  • Hemoglobin (Hgb) >= 10 g/dL
  • Total bilirubin: within normal institutional limits (WNL) OR direct bilirubin =< upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN
  • International normalized ratio (INR) =< 1.5
  • Calculated creatinine clearance >= 45 mL/min using the Cockcroft-Gault formula
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
  • Negative pregnancy test done =< 7 days prior to pre-registration, for women of childbearing potential only
  • Ability to provide informed consent
  • Life expectancy >= 12 weeks
  • Tissue available and willing to submit tissue for central pathology review and EGFR evaluation; performed on original diagnostic/recurrent tissue (preferably paraffin-embedded tissue blocks); if institution unable to release tissue blocks, willing to submit 25 unstained slides (15 sections cut at 5 microns mounted on charged slides and 10 sections cut at 10 microns mounted on uncharged slides)
  • Must be previously treated for advanced disease with only 1 chemotherapy regimen which must contain cytotoxic agent(s); adjuvant/neoadjuvant treatment with cytotoxic agent(s) administered < 12 months (from date chemotherapy was started) prior to pre-registration will be considered as one prior treatment; NOTE: adjuvant/neoadjuvant treatment administered >= 12 months, use of targeted agents such as monoclonal antibodies prior to pre-registration will NOT be counted as one prior treatment; patient could have had adjuvant/neoadjuvant chemotherapy >= 12 months and 1 systemic chemotherapy regimen for metastatic or recurrent disease
  • Able to take folic acid, vitamin B12 supplementation, and dexamethasone
  • Able to permanently discontinue aspirin dose of >= 1.3 grams/day >= 10 days before and after pemetrexed treatment
  • Fertile patients must use effective contraception
  • Able to take folic acid, vitamin B_12 supplementation, and dexamethasone
  • Stable brain metastasis that have been treated with either whole brain radiation therapy or gamma knife surgery and are off steroid treatment for > 14 days prior to pre-registration, if applicable
  • Willingness to return to enrolling institution for treatment and follow-up

Who cannot join

  • Any of the following:
  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Any clinically significant infection, at the treating physician's discretion
  • Known human immunodeficiency virus (HIV) positive patients
Show all 43Show fewer
  • Impairment of 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, bowel obstruction, etc)
  • Serious condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study or increase the risk for serious adverse events
  • Any of the following prior therapies:
  • Prior radiation to > 25% of bone marrow
  • EGFR tyrosine kinase inhibitors
  • Pemetrexed
  • Chemotherapy =< 3 weeks prior to pre-registration
  • Mitomycin C/nitrosoureas =< 6 weeks prior to pre-registration
  • Immunotherapy =< 2 weeks prior to pre-registration
  • Biologic therapy =< 2 weeks prior to pre-registration
  • Gene therapy =< 2 weeks prior to pre-registration
  • Full field radiation therapy =< 4 weeks prior to pre-registration
  • Limited field radiation therapy =< 2 weeks prior to pre-registration
  • Major surgery (i.e., laparotomy), open biopsy, or significant traumatic injury =< 4 weeks prior to pre-registration or anticipation of need for major surgical procedure during the course of the study; minor surgery =< 2 weeks prior to pre-registration; insertion of a vascular access device is not considered major or minor surgery in this regard
  • Other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation) =< 4 weeks prior to pre-registration
  • Steroid therapy for brain metastasis =< 14 days prior to pre-registration
  • Symptomatic serosal effusion (>= Common Terminology Criteria for Adverse Events [CTCAE] v3.0 grade 2 dyspnea) that is not amenable to drainage prior to pre-registration
  • Other invasive solid or hematologic malignancy; exceptions: prior malignancy was diagnosed and definitively treated >= 5 years previously with no subsequent evidence of recurrence; patients with a history of low-grade (Gleason score =< 6) localized prostate cancer will be eligible even if diagnosed < 3 years prior to pre-registration; these patients may continue on medications concomitantly to maintain their disease remission as necessary; patients with carcinoma in situ, regardless of organ involvement, or non-melanoma cutaneous carcinomas are eligible if these were definitively treated >= 3 years previously with no subsequent evidence of recurrence; Note: patients with breast cancer that was definitively treated > 5 years earlier but continue to receive aromatase inhibitors are NOT eligible
  • Only non-measurable disease, defined as all other lesions, including small lesions whose longest diameter measures < 2 cm with conventional techniques or < 1.0 cm with spiral CT, and truly non-measurable lesions, which include the following as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria dated June 1999:
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Inflammatory breast disease
  • Lymphangitis cutis/pulmonis
  • Abdominal masses that are not confirmed and followed by imaging techniques
  • Cystic lesions
  • Single disease site in prior radiation field
  • Any of the following concurrent severe and/or uncontrolled medical conditions:
  • Angina pectoris
  • History of congestive heart failure =< 3 months prior to pre-registration, unless ejection fraction > 40%
  • Myocardial infarction =< 6 months prior to pre-registration
  • Cardiac arrhythmia
  • Diabetes mellitus
  • Hypertension
  • Any other severe underlying diseases which are, in the judgment of the investigator, inappropriate for entry into this study
  • Respiratory symptoms > CTCAE grade 1

Trial locations and contacts

269 sites in 2 countries.

269 sites in 2 countries

United States268 sites

  • Bixby Medical Center

    Adrian, Michigan, 49221

  • Hickman Cancer Center

    Adrian, Michigan, 49221

  • McFarland Clinic PC-William R Bliss Cancer Center

    Ames, Iowa, 50010

  • AnMed Health Hospital

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Michigan Cancer Research Consortium CCOP

    Ann Arbor, Michigan, 48106

  • Hospital District Sixth of Harper County

    Anthony, Kansas, 67003

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Franciscan St. Francis Health-Beech Grove

    Beech Grove, Indiana, 46107

  • MacNeal Hospital and Cancer Center

    Berwyn, Illinois, 60402

  • Hematology Oncology Associates-Quad Cities

    Bettendorf, Iowa, 52722

  • Spectrum Health Big Rapids Hospital

    Big Rapids, Michigan, 49307

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Frontier Cancer Center and Blood Institute-Billings

    Billings, Montana, 59102

  • Billings Clinic Cancer Center

    Billings, Montana, 59107

  • Mid Dakota Clinic

    Bismarck, North Dakota, 58501

  • Saint Alexius Medical Center

    Bismarck, North Dakota, 58501

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Lynn Regional Cancer Center - West

    Boca Raton, Florida, 33428

  • Boca Raton Comprehensive Cancer Center

    Boca Raton, Florida, 33486

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Toledo Clinic Cancer Centers-Bowling Green

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Steward Saint Elizabeth's Medical Center

    Brighton, Massachusetts, 02135-2997

  • Bristol Hospital

    Bristol, Connecticut, 06011

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Graham Hospital Association

    Canton, Illinois, 61520

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • Cedar Rapids Oncology Association

    Cedar Rapids, Iowa, 52403

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Hematology and Oncology Associates

    Chicago, Illinois, 60611

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • North Coast Cancer Care-Clyde

    Clyde, Ohio, 43410

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Genesis Medical Center - East Campus

    Davenport, Iowa, 52803

  • Genesis Medical Center - West Campus

    Davenport, Iowa, 52804

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Health Center

    Dayton, Ohio, 45415

  • Dayton CCOP

    Dayton, Ohio, 45420

  • Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48124

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Exempla Saint Joseph Hospital

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • Colorado Cancer Research Program CCOP

    Denver, Colorado, 80224-2522

  • Mercy Capitol

    Des Moines, Iowa, 50307

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa Oncology Research Association CCOP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Veterans Adminstration New Jersey Health Care System

    East Orange, New Jersey, 07018-1095

  • The Memorial Hospital at Easton

    Easton, Maryland, 21601

  • Hematology Oncology Center Incorporated

    Elyria, Ohio, 44035

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Eureka Hospital

    Eureka, Illinois, 61530

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Hurley Medical Center

    Flint, Michigan, 48502

  • Genesys Regional Medical Center-West Flint Campus

    Flint, Michigan, 48532

  • Sparks Regional Medical Center

    Fort Smith, Arkansas, 72901

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Fredericksburg Oncology Inc

    Fredericksburg, Virginia, 22401

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • Illinois CancerCare Galesburg

    Galesburg, Illinois, 61401

  • Illinois CancerCare-Cottage

    Galesburg, Illinois, 61401

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Altru Cancer Center

    Grand Forks, North Dakota, 58201

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81502

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Berdeaux, Donald MD (UIA Investigator)

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Illinois CancerCare-Havana

    Havana, Illinois, 62644

  • Mason District Hospital

    Havana, Illinois, 62644

  • Northern Montana Hospital

    Havre, Montana, 59501

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Hematology Oncology Associates of Illinois-Highland Park

    Highland Park, Illinois, 60035

  • Hopedale Medical Complex - Hospital

    Hopedale, Illinois, 61747

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Allegiance Health

    Jackson, Michigan, 49201

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Midwest Center for Hematology Oncology

    Joliet, Illinois, 60432

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Truman Medical Center

    Kansas City, Missouri, 64108

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64111

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Saint Joseph Health Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Research Medical Center

    Kansas City, Missouri, 64132

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Liberty Hospital

    Liberty, Missouri, 64068

  • Liberty Radiation Oncology Center

    Liberty, Missouri, 64068

  • NorthShore Hematology Oncology-Libertyville

    Libertyville, Illinois, 60048

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Meeker County Memorial Hospital

    Litchfield, Minnesota, 55355

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Mcdonough District Hospital

    Macomb, Illinois, 61455

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Memorial Hospital Of Martinsville

    Martinsville, Virginia, 24115

  • Fremont - Rideout Cancer Center

    Marysville, California, 95901

  • Saint Luke's Hospital

    Maumee, Ohio, 43537

  • Toledo Clinic Cancer Centers-Maumee

    Maumee, Ohio, 43537

  • Toledo Radiation Oncology at Northwest Ohio Onocolgy Center

    Maumee, Ohio, 43537

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Middlesex Hospital

    Middletown, Connecticut, 06457

  • Minnesota Cooperative Group Outreach Program

    Minneapolis, Minnesota, 55407

  • Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Community Medical Hospital

    Missoula, Montana, 59801

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Holy Family Medical Center

    Monmouth, Illinois, 61462

  • Illinois CancerCare-Monmouth

    Monmouth, Illinois, 61462

  • Mercy Memorial Hospital

    Monroe, Michigan, 48162

  • Toledo Clinic Cancer Centers-Monroe

    Monroe, Michigan, 48162

  • Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County

    Mount Holly, New Jersey, 08060

  • Mercy Health Mercy Campus

    Muskegon, Michigan, 49444

  • DuPage Medical Group-Ogden

    Naperville, Illinois, 60563

  • Illinois Cancer Specialists-Niles

    Niles, Illinois, 60714

  • Bromenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center Foundation

    Normal, Illinois, 61761

  • Illinois CancerCare-Community Cancer Center

    Normal, Illinois, 61761

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

  • Saint Charles Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic Cancer Centers-Oregon

    Oregon, Ohio, 43616

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Ottawa Regional Hospital and Healthcare Center

    Ottawa, Illinois, 61350

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Saint Luke's South Hospital

    Overland Park, Kansas, 66213

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Pekin Hospital

    Pekin, Illinois, 61554

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61603

  • Proctor Hospital

    Peoria, Illinois, 61614

  • OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC

    Peoria, Illinois, 61615-7827

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Illinois Oncology Research Association CCOP

    Peoria, Illinois, 61615

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Illinois Valley Hospital

    Peru, Illinois, 61354

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Valley Care Health System - Pleasanton

    Pleasanton, California, 94588

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Saint Joseph Mercy Port Huron

    Port Huron, Michigan, 48060

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Saint Mary Corwin Medical Center

    Pueblo, Colorado, 81004

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Riverview Medical Center/Booker Cancer Center

    Red Bank, New Jersey, 07701

  • Kaiser Permanente-Redwood City

    Redwood City, California, 94063

  • Kaiser Permanente-Richmond

    Richmond, California, 94801

  • Reid Hospital and Health Care Services

    Richmond, Indiana, 47374

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • Cancer Trials Support Unit

    Rockville, Maryland, 20850-2062

  • Kaiser Permanente-Roseville

    Roseville, California, 95661

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Kaiser Permanente-South Sacramento

    Sacramento, California, 95823

  • Kaiser Permanente - Sacramento

    Sacramento, California, 95825

  • Saint Mary's of Michigan

    Saginaw, Michigan, 48601

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Kaiser Permanente-San Francisco

    San Francisco, California, 94115

  • Kaiser Permanente-Santa Teresa-San Jose

    San Jose, California, 95119

  • Kaiser Permanente San Leandro

    San Leandro, California, 94577

  • Kaiser Permanente-San Rafael

    San Rafael, California, 94903

  • North Coast Cancer Care

    Sandusky, Ohio, 44870

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051

  • Kaiser Permanente-Santa Rosa

    Santa Rosa, California, 95403

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Mercy Hospital

    Scranton, Pennsylvania, 18501

  • Scranton Hematology Oncology

    Scranton, Pennsylvania, 18510

  • Shawnee Mission Medical Center-KCCC

    Shawnee Mission, Kansas, 66204

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101

  • Mercy Medical Center-Sioux City

    Sioux City, Iowa, 51104

  • Saint Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Hematology Oncology Associates of Illinois - Skokie

    Skokie, Illinois, 60076

  • Kaiser Permanente-South San Francisco

    South San Francisco, California, 94080

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Illinois CancerCare-Spring Valley

    Spring Valley, Illinois, 61362

  • Saint Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Saint Louis University Hospital

    St Louis, Missouri, 63110

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Center for Cancer Care and Research

    St Louis, Missouri, 63141

  • Geisinger Medical Group

    State College, Pennsylvania, 16801

  • Mount Nittany Medical Center

    State College, Pennsylvania, 16803

  • Kaiser Permanente-Stockton

    Stockton, California, 95210

  • Flower Hospital

    Sylvania, Ohio, 43560

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • Syracuse Veterans Administration Medical Center

    Syracuse, New York, 13210

  • North Suburban Medical Center

    Thornton, Colorado, 80229

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • The Toledo Hospital/Toledo Children's Hospital

    Toledo, Ohio, 43606

  • Saint Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • University of Toledo

    Toledo, Ohio, 43614

  • Toledo Community Hospital Oncology Program CCOP

    Toledo, Ohio, 43617

  • Mercy Saint Anne Hospital

    Toledo, Ohio, 43623

  • Toledo Clinic Cancer Centers-Toledo

    Toledo, Ohio, 43623

  • Stormont-Vail Regional Health Center

    Topeka, Kansas, 66604

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Upper Valley Medical Center

    Troy, Ohio, 45373

  • Tahoe Forest Cancer Center

    Truckee, California, 96161

  • Kaiser Permanente Medical Center-Vacaville

    Vacaville, California, 95688

  • Kaiser Permanente-Vallejo

    Vallejo, California, 94589

  • Virtua West Jersey Hospital Voorhees

    Voorhees Township, New Jersey, 08043

  • Kaiser Permanente-Walnut Creek

    Walnut Creek, California, 94596

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • Covenant Medical Center

    Waterloo, Iowa, 50702

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • SCL Health Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Clinton Memorial Hospital

    Wilmington, Ohio, 45177

  • Southeast Cancer Consortium-Upstate NCORP

    Winston-Salem, North Carolina, 27104

  • Metro Health Hospital

    Wyoming, Michigan, 49519

  • Greene Memorial Hospital

    Xenia, Ohio, 45385

Other trials in United States

Canada1 site

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

Other trials in Canada

About this study

Official title: MARVEL: Marker Validation of Erlotinib in Lung Cancer- 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

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate whether there are differences in progression-free survival due to treatment with erlotinib (erlotinib hydrochloride) compared to pemetrexed (pemetrexed disodium) for subsets of previously treated non-small cell lung cancer (NSCLC) patients defined by epidermal growth factor receptor (EGFR)-fluorescent in situ hybridization (FISH) positive versus negativity.

SECONDARY OBJECTIVES:

  1. Ascertain the presence or absence of true differences due to treatment in the objective clinical endpoints of overall survival, confirmed response rate, and adverse event profile for subsets of patients defined on the basis of the epidermal growth factor receptor (EGFR)-FISH positivity versus negativity.

II. Ascertain the presence or absence of true differences due to treatment in objective clinical endpoints (i.e., progression free survival, overall survival, confirmed response rate, and adverse event profile) for subsets of patients defined on the basis of the epidermal growth factor receptor (EGFR) expression as measured by immunohistochemistry (IHC).

III. Ascertain the presence or absence of true differences due to treatment in objective clinical endpoints (i.e., progression free survival, overall survival, confirmed response rate, and adverse event profile) for subsets of patients defined on the basis of the epidermal growth factor receptor (EGFR) gene mutation status (MUT).

IV. To evaluate the prognostic effect of EGFR copy number as measured by FISH separately by treatment arm, i.e., is there a difference in outcome for FISH(+) patients receiving erlotinib compared to FISH (-) patients receiving erlotinib, and similarly is there a difference in outcome for FISH(+) patients receiving pemetrexed compared to FISH (-) patients receiving pemetrexed.

  1. To evaluate the prognostic effect of EGFR expression as measured by IHC separately by treatment arm, i.e., is there a difference in outcome for IHC(+) patients receiving erlotinib compared to IHC (-) patients receiving erlotinib, and similarly is there a difference in outcome for IHC(+) patients receiving pemetrexed compared to IHC (-)patients receiving pemetrexed.

VI. To evaluate the prognostic effect of EGFR mutation status separately by treatment arm, i.e., is there a difference in outcome for MUT(+) patients receiving erlotinib compared to MUT(-) patients receiving erlotinib, and similarly is there a difference in outcome for MUT(+) patients receiving pemetrexed compared to MUT(-) patients receiving pemetrexed.

VII. To prospectively test the hypothesis that functionally relevant polymorphisms in the genes encoding for pemetrexed targets, as well as genes encoding for one or more of the key enzymes involved in the transport, activation, and inactivation of pemetrexed, either singly or in combination, play a role in the efficacy and/or toxicity of pemetrexed.

VIII. To prospectively test the hypothesis that functionally relevant polymorphisms in the EGFR gene as well as genes encoding for one or more of the key enzymes involved in the metabolism of erlotinib, either singly or in combination, play a role in the efficacy and/or toxicity of erlotinib.

IX. Evaluate proteomic signatures in blood samples as predictors of survival and response to treatment with erlotinib.

  1. To evaluate expression of thymidylate synthase, dihydrofolate reductase, phosphoribosylglycineamide (GAR) formyltransferase, and methylthioadenosine phosphorylase gene expression in tumor samples, as measured by IHC or quantitative polymerase chain reaction, as predictors of survival and response to treatment with pemetrexed.

XI. To evaluate proteomic signatures in blood samples of patients as predictors of response and survival to treatment with erlotinib.

XII. To evaluate the following variables measured in tumor samples, as predictors of response and survival to treatment with pemetrexed: Expression of thymidylate synthase, dihydrofolate reductase and GAR formyltransferase genes methylthioadenosine phosphorylase expression by IHC or quantitative polymerase chain reaction (PCR).

XIII. To evaluate the following variables measured in tumor samples, as predictors of response and survival to treatment with erlotinib: Rat sarcoma (Ras) mutational status, EGFR mutational status and, epithelial to mesenchymal transition (EMT) status (measured by E-cadherin expression and vimentin expression) by IHC.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive pemetrexed disodium intravenously (IV) over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.

Being tested
Erlotinib Hydrochloride, Pemetrexed Disodium
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Erlotinib HydrochlorideDrug

    Also called Cp-358,774, OSI-774, Tarceva

    Given PO

  • Pemetrexed DisodiumDrug

    Also called Alimta, LY231514, N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt

    Given IV

Study groups in NCT00738881
Study groupRoleWhat they receive
Arm I (erlotinib hydrochloride)ExperimentalPatients receive erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Erlotinib Hydrochloride
Arm II (pemetrexed disodium)ExperimentalPatients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Pemetrexed Disodium

What is being measured

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

  1. Progression-free Survival (PFS)

    Estimated using the method of Kaplan-Meier survival curves to compare PFS between the erlotinib and pemetrexed arms using an intent-to-treat (ITT) analysis. Due to the small sample size (21 of the required 954 patients ~2%), analyses within the FISH(+) and FISH(-) groups were not performed, and no formal analyses for the primary or the secondary efficacy outcomes were performed.

    Measured: Time from randomization to the first date of documented disease progression or death, assessed up to 5 years

Secondary outcomes (3)

  1. Time to Treatment Failure

    The distribution of all time to event data will be estimated using the method of Kaplan-Meier survival curves.

    Measured: The time from date of randomization to the date at which the patient is removed from the treatment, assessed up to 5 years

  2. Overall Survival

    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 epidermal growth factor receptor (EGFR) expression by immunohistochemistry (IHC), and EGFR gene mutation status (MUT). Cox proportional hazards model will be used to assess potential differences.

    Measured: Time from randomization to time of death from any cause, assessed up to 5 years

  3. Confirmed Response Rate Defined as Complete Response (CR) or a Partial Response (PR) Per Response Evaluation Criteria In Solid Tumors (RECIST)

    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.

    Measured: Up to 5 years

Timeline

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

  1. First posted21 Aug 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionDec 2011
  4. Study completionDec 2014

Why it stopped: Slow accrual

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
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00738881
Sponsor's protocol ID
NCI-2009-00663
Other IDs
NCI-2009-00663, CDR0000612010, NCCTG-N0723, CALGB-30802, CAN-NCIC-BRC4, N0723, N0723, U10CA180821
Acronym
MARVEL
Status last verified
Dec 2014
First submitted
20 Aug 2008
Last updated
29 Oct 2015

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Erlotinib Hydrochloride and Pemetrexed Disodium in people with Recurrent Non-Small Cell Lung Carcinoma and Stage IIIA Non-Small Cell Lung Cancer, run by National Cancer Institute (NCI) at 269 sites in 2 countries.

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 26 inclusion and 43 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: stopped early, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 269 sites in United States, Canada. 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 2 Oct 2014). 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?

Progression-free Survival (PFS) (time frame: Time from randomization to the first date of documented disease progression or death, assessed up to 5 years). 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 NCT00738881.

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 29 Oct 2015.

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