AzTrials
AzTrials

Recurrent Non-small Cell Lung CancerPhase 2NCT00986674

Carboplatin and Paclitaxel Combined With Cetuximab and/or IMC-A12 in Patients With Advanced Non-Small Cell Lung Cancer

A Phase 2 study testing cixutumumab, carboplatin and paclitaxel in people with Recurrent Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 249 sites in United States.

Completed

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

Official record
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Trial summary

This randomized phase II trial is studying how well giving carboplatin and paclitaxel together with cetuximab and/or cixutumumab (IMC-A12) works in treating patients with stage IIIB or stage IV non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cixutumumab, carboplatin and paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
249 sitesUnited States
Study dates
Sep 2009to Dec 2013
Phase
Phase 2
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

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
  • Stage IIIB disease
  • T4, NX with nodule in ipsilateral lung lobe allowed provided patient is not a candidate for combined chemotherapy and radiotherapy
  • Stage IV disease (includes M1a and M1b)
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • Ineligible for or refused treatment with bevacizumab
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  • No untreated or symptomatic central nervous system (CNS) metastases
  • Patients with a history of CNS metastases that are definitively treated, stable, and controlled are eligible provided the following criteria are met:
  • Definitive therapy (surgery and/or radiotherapy) has been administered
  • Not planning to undergo additional treatment for brain metastases
  • Clinically stable
  • Off corticosteroids or on a stable dose of corticosteroids for ≥ 14 days before study entry
  • ECOG performance status 0-1
  • Leukocytes > 3,000/mm^3
  • Absolute neutrophil count (ANC) > 1,500/mm^3
  • Hemoglobin > 9 g/dL
  • Platelet count > 100,000/mm^3
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Aspartate Aminotransferase (AST) < 3 times ULN (< 5 times ULN if elevations due to liver metastases)
  • Creatinine < 1.5 times ULN OR creatinine clearance > 60 mL/min
  • Fasting serum glucose < 120 mg/dL
  • Partial thromboplastin time (PTT) ≤ 1.2 times ULN and international normalized ratio (INR) ≤ 1.5 (unless patient is on anticoagulation therapy)
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after the last dose of cixutumumab
  • No poorly controlled diabetes mellitus
  • Patients with a history of diabetes mellitus are eligible provided their blood glucose is within normal range and they are on a stable dietary or therapeutic regimen for this condition
  • No other prior or concurrent malignancy, except for the following:
  • Curatively treated malignancy with no known active disease for ≥ 3 years AND is considered to be at low risk for recurrence by the treating physician
  • Adequately treated nonmelanoma skin cancer or lentigo maligna with no evidence of disease
  • Adequately treated cervical carcinoma in situ with no evidence of disease
  • Prostatic intraepithelial neoplasia with no evidence of prostate cancer
  • Concurrent therapeutic anticoagulation allowed provided there is no bleeding and patient is on a stable dose of anticoagulation therapy (e.g., Warfarin with an INR of 2-3) for > 2 weeks prior to study entry
  • At least 21 days since prior radiotherapy
  • More than 4 weeks since prior major surgery or hormonal therapy (other than hormone replacement therapy) and recovered
  • More than 1 year since prior neoadjuvant or adjuvant chemotherapy

Who cannot join

  • Small cell lung cancer or mixed small cell and NSCLC
  • History of allergic reactions attributed to compounds of similar chemical or biological composition to cixutumumab
  • History of any medical or psychiatric condition, addictive disorder, or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with study participation or study treatments or may interfere with the conduct of the study or interpretation of study results
  • Prior agents targeting the EGFR or Insulin-like growth factor (IGFR) pathways
  • Prior therapy for advanced NSCLC, except for surgery and/or radiotherapy
  • Prior systemic therapy, including bevacizumab for advanced stage NSCLC
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  • Pregnant or nursing
  • Peripheral neuropathy > grade 1 as per Common Terminology Criteria for Adverse Event (CTCAE) v 4.0
  • History of or suspected interstitial pneumonitis or pulmonary fibrosis on imaging
  • Significant uncontrolled cardiac disease within the past 6 months, including any of the following:
  • Uncontrolled hypertension (BP > 150/100 mm Hg)
  • Unstable angina
  • Recent myocardial infarction
  • Uncontrolled congestive heart failure
  • Cardiomyopathy with decreased ejection fraction
  • Arterial thrombosis, pulmonary embolus, deep vein thrombosis, or hemorrhagic disorders within the past 28 days

Trial locations and contacts

249 sites in 1 country.

249 sites in 1 country

United States249 sites

  • Bixby Medical Center

    Adrian, Michigan, 49221

  • Hickman Cancer Center

    Adrian, Michigan, 49221

  • Summa Akron City Hospital/Cooper Cancer Center

    Akron, Ohio, 44304

  • New York Oncology Hematology PC - Albany

    Albany, New York, 12206

  • New York Oncology Hematology PC -Albany Medical Center

    Albany, New York, 12208

  • New York Oncology Hematology PC - Amsterdam

    Amsterdam, New York, 12010

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Michigan Cancer Research Consortium Community Clinical Oncology Program

    Ann Arbor, Michigan, 48106

  • Fox Valley Hematology and Oncology

    Appleton, Wisconsin, 54911-3496

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Mary Rutan Hospital

    Bellefontaine, Ohio, 43311

  • Constantinou, Costas L MD (UIA Investigator)

    Bettendorf, Iowa, 52722

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61701

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Toledo Clinic Cancer Centers-Bowling Green

    Bowling Green, Ohio, 43402

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Graham Hospital Association

    Canton, Illinois, 61520

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Cedar Rapids Oncology Association

    Cedar Rapids, Iowa, 52403

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • West Virginia University Charleston

    Charleston, West Virginia, 25304

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • North Coast Cancer Care-Clyde

    Clyde, Ohio, 43410

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Columbus CCOP

    Columbus, Ohio, 43215

  • Grant Medical Center

    Columbus, Ohio, 43215

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Danbury Hospital

    Danbury, Connecticut, 06810

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Oakwood Hospital

    Dearborn, Michigan, 48124

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • 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

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Essentia Health Duluth Clinic CCOP

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Marshfield Clinic Cancer Center at Sacred Heart

    Eau Claire, Wisconsin, 54701

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Hematology Oncology Center Incorporated

    Elyria, Ohio, 44035

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Green Bay Oncology - Escanaba

    Escanaba, Michigan, 49431

  • Eureka Hospital

    Eureka, Illinois, 61530

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Evanston CCOP-NorthShore University HealthSystem

    Evanston, Illinois, 60201

  • Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Hurley Medical Center

    Flint, Michigan, 48502

  • Genesys Regional Medical Center-West Flint Campus

    Flint, Michigan, 48532

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Vanderbilt-Ingram Cancer Center Cool Springs

    Franklin, Tennessee, 37067

  • Fredericksburg Oncology Inc

    Fredericksburg, Virginia, 22401

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Illinois CancerCare Galesburg

    Galesburg, Illinois, 61401

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81502

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Illinois CancerCare-Havana

    Havana, Illinois, 62644

  • Mason District Hospital

    Havana, Illinois, 62644

  • Geisinger Medical Center-Cancer Center Hazelton

    Hazleton, Pennsylvania, 18201

  • Hinsdale Hematology Oncology Associates Incorporated

    Hinsdale, Illinois, 60521

  • New York Oncology Hematology PC-Hudson

    Hudson, New York, 12534

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Indiana University Medical Center

    Indianapolis, Indiana, 46202

  • Richard L. Roudebush Veterans Affairs Medical Center

    Indianapolis, Indiana, 46202

  • Wishard Hospital

    Indianapolis, Indiana, 46202

  • Green Bay Oncology - Iron Mountain

    Iron Mountain, Michigan, 49801

  • Allegiance Health

    Jackson, Michigan, 49201

  • UW Cancer Center Johnson Creek

    Johnson Creek, Wisconsin, 53038

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • Gundersen Lutheran

    La Crosse, Wisconsin, 54601

  • Indiana University Health La Porte Hospital

    La Porte, Indiana, 46350

  • IU Health Arnett

    Lafayette, Indiana, 47904

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17604

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Nevada Cancer Research Foundation CCOP

    Las Vegas, Nevada, 89106

  • New York Oncology Hematology PC - Latham

    Latham, New York, 12110

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67901

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Nebraska Cancer Research Center

    Lincoln, Nebraska, 68510

  • 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

  • Medical Center of Central Georgia

    Macon, Georgia, 31208

  • UW Health Oncology - 1 South Park

    Madison, Wisconsin, 53715

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Manchester Memorial Hospital

    Manchester, Connecticut, 06040

  • Holy Family Memorial Hospital

    Manitowoc, Wisconsin, 54221

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • 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

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548

  • Saint Joseph Regional Medical Center-Mishawaka

    Mishawaka, Indiana, 46545-1470

  • Garneau, Stewart C MD (UIA Investigator)

    Moline, Illinois, 61265

  • Porubcin, Michael MD (UIA Investigator)

    Moline, Illinois, 61265

  • Sharis, Christine M MD (UIA Investigator)

    Moline, Illinois, 61265

  • Spector, David MD (UIA Investigator)

    Moline, Illinois, 61265

  • Stoffel, Thomas J MD (UIA Investigator)

    Moline, Illinois, 61265

  • Trinity Medical Center

    Moline, Illinois, 61265

  • Holy Family Medical Center

    Monmouth, Illinois, 61462

  • Illinois CancerCare-Monmouth

    Monmouth, Illinois, 61462

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital

    Monroe, Michigan, 48162

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

    Mount Holly, New Jersey, 08060

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • Nashville Oncology Associates PC

    Nashville, Tennessee, 37203

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Bromenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center Foundation

    Normal, Illinois, 61761

  • Illinois CancerCare-Community Cancer Center

    Normal, Illinois, 61761

  • Fisher-Titus Medical Center

    Norwalk, Ohio, 44857

  • Green Bay Oncology - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • Missouri Valley Cancer Consortium CCOP

    Omaha, Nebraska, 68106

  • Alegent Health Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • UHHS-Chagrin Highlands Medical Center

    Orange, Ohio, 44122

  • 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

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Pekin Hospital

    Pekin, Illinois, 61554

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61603

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61603

  • Proctor Hospital

    Peoria, Illinois, 61614

  • 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

  • Abramson Cancer Center of The University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15232

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Saint Joseph Mercy Port Huron

    Port Huron, Michigan, 48060

  • Pottstown Memorial Medical Center

    Pottstown, Pennsylvania, 19464

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Saint Mary Corwin Medical Center

    Pueblo, Colorado, 81004

  • New York Oncology Hematology PC - Rexford

    Rexford, New York, 12148

  • Marshfield Clinic at James Beck Cancer Center

    Rhinelander, Wisconsin, 54501

  • Marshfield Clinic-Rice Lake Center

    Rice Lake, Wisconsin, 54868

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Saint Mary's of Michigan

    Saginaw, Michigan, 48601

  • Lakeland Hospital

    Saint Joseph, Michigan, 49085

  • Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Metro-Minnesota CCOP

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • North Coast Cancer Care

    Sandusky, Ohio, 44870

  • Mercy Hospital

    Scranton, Pennsylvania, 18501

  • Scranton Hematology Oncology

    Scranton, Pennsylvania, 18510

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Siouxland Hematology Oncology Associates

    Sioux City, Iowa, 51101

  • Mercy Medical Center-Sioux City

    Sioux City, Iowa, 51104

  • Saint Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46628

  • Illinois CancerCare-Spring Valley

    Spring Valley, Illinois, 61362

  • Saint Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Springfield Regional Medical Center

    Springfield, Ohio, 45505

  • Stanford University Hospitals and Clinics

    Stanford, California, 94305

  • Geisinger Medical Group

    State College, Pennsylvania, 16801

  • Marshfield Clinic Cancer Care at Saint Michael's Hospital

    Stevens Point, Wisconsin, 54481

  • Green Bay Oncology - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • Flower Hospital

    Sylvania, Ohio, 43560

  • Scott and White Memorial Hospital

    Temple, Texas, 76508

  • 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

  • New York Oncology Hematology PC - Troy

    Troy, New York, 12180

  • Natalie Warren Bryant Cancer Center at Saint Francis

    Tulsa, Oklahoma, 74136

  • Virtua West Jersey Hospital Voorhees

    Voorhees Township, New Jersey, 08043

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • Marshfield Clinic-Wausau Center

    Wausau, Wisconsin, 54401

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Saint Ann's Hospital

    Westerville, Ohio, 43081

  • UHHS-Westlake Medical Center

    Westlake, Ohio, 44145

  • Marshfield Clinic - Weston Center

    Weston, Wisconsin, 54476

  • Exempla Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • Wheeling Hospital

    Wheeling, West Virginia, 26003

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Main Office

    Wichita, Kansas, 67214

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wichita CCOP

    Wichita, Kansas, 67214

  • Geisinger Wyoming Valley

    Wilkes-Barre, Pennsylvania, 18711

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Marshfield Clinic - Wisconsin Rapids Center

    Wisconsin Rapids, Wisconsin, 54494

  • Riverview Hospital

    Wisconsin Rapids, Wisconsin, 54494

  • Minnesota Oncology and Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

  • Mainline Health CCOP

    Wynnewood, Pennsylvania, 19096

  • Genesis HealthCare System

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: Three-Arm Randomized Phase II Study of Carboplatin and Paclitaxel in Combination With Cetuximab, IMC-A12 or Both in Patients With Advanced Non-Small Cell Lung Cancer Who Will Not Receive Bevacizumab-Based Therapy

This randomized phase II trial is studying how well giving carboplatin and paclitaxel together with cetuximab and/or cixutumumab (IMC-A12) works in treating patients with stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy together with monoclonal antibody therapy may kill more tumor cells. It is not yet known whether carboplatin and paclitaxel are more effective when given with cetuximab and/or cixutumumab in treating non-small cell lung cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the progression-free survival of patients with non-small cell lung cancer (NSCLC) randomized to carboplatin plus paclitaxel plus cetuximab or carboplatin plus paclitaxel plus cixutumumab (IMC-A12) or carboplatin plus paclitaxel plus cetuximab plus cixutumumab.

SECONDARY OBJECTIVES:

  1. To evaluate the response rate, disease control rate (complete response plus partial response plus stable disease), and toxicities for each arm.

II. To evaluate epidermal growth factor receptor (EGFR) by Immunohistochemistry (IHC), mutation, and gene copy number, Insulin-like growth factor 1 receptor (IGF-1R) and Insulin-like growth factor 2 receptor (IGF-2R) expression (both phosphorylated and unphosphorylated states), expression of p-AKT (ie, Protein Kinase B) by IHC, and k-ras mutation.

III. Plasma-based biomarkers will be evaluated for total and free insulin-like growth factor 1 and 2, IGF-growth factor binding protein 3 (IGFBP3) and circulating levels of epidermal growth factor (EGF) and Transforming growth factor (TGF) alpha.

IV. To evaluate overall survival on each of the three arms.

OUTLINE: This is a multicenter study. Patients are stratified according to gender and histology (squamous cell vs non-squamous cell). Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive carboplatin intravenously (IV) over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.

ARM III: Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.

Tumor tissue samples are collected at baseline for analysis of EGFR expression by IHC, mutation, and gene copy number; IGF-1R and IGF-2R expression (both phosphorylated and unphosphorylated states); p-AKT expression by IHC; and k-ras mutation. Blood, serum, and plasma samples are collected periodically for biomarker analysis.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: 200 patients

Being tested
cixutumumab, carboplatin, paclitaxel, cetuximab
Keywords
Advanced Non-small Cell Lung Cancer, Carboplatin, Paclitaxel, Cetuximab, IMC-A12
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.

  • cixutumumabBiological

    Also called anti-IGF-1R recombinant monoclonal antibody IMC-A12, IMC-A12

    Given IV

  • carboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Given IV

  • paclitaxelDrug

    Also called Anzatax, Asotax, TAX, Taxol

    Given IV

  • cetuximabBiological

    Also called C225, C225 monoclonal antibody, IMC-C225, MOAB C225

    Given IV

Study groups in NCT00986674
Study groupRoleWhat they receive
Arm I (carboplatin, paclitaxel, cetuximab)ExperimentalPatients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: carboplatin; Drug: paclitaxel; Biological: cetuximab
Arm II (carboplatin, paclitaxel, cixutumumab)ExperimentalPatients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
Receives: Biological: cixutumumab; Drug: carboplatin; Drug: paclitaxel
Arm III (carboplatin, paclitaxel, cetuximab, cixutumumab)ExperimentalPatients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.
Receives: Biological: cixutumumab; Drug: carboplatin; Drug: paclitaxel; Biological: cetuximab

What is being measured

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

  1. Progression Free Survival

    Progression free survival is defined as time from registration to disease progression or death from any cause, whichever occurred earlier. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions .

    All eligible and treated patients were included in the analysis.

    Measured: Tumor measurements are repeated every 6 weeks while on treatment. After off treatment, assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3

Secondary outcomes (2)

  1. Overall Survival

    Overall survival is defined as time from registration to death from any cause.

    Measured: assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3

  2. Response Rate

    Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Complete response (CR) was defined disappearance of all tumor lesions. Partial response (PR) was defined as as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. Overall response rate= CR+PR.

    Measured: Tumor measurements are repeated every 6 weeks while on treatment. After off treatment, assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3

Timeline

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

  1. First posted30 Sep 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionAug 2013
  4. Study completionDec 2013

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00986674
Sponsor's protocol ID
NCI-2011-01976
Other IDs
E4508, U10CA021115
Status last verified
Mar 2014
First submitted
29 Sep 2009
Last updated
26 Sep 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cixutumumab, carboplatin and paclitaxel in people with Recurrent Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 249 sites in United States.

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

Who may be eligible to take part?

The sponsor lists 35 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 249 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 26 Sep 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 (time frame: Tumor measurements are repeated every 6 weeks while on treatment. After off treatment, assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3). 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 NCT00986674.

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 26 Sep 2014.

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