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

September 19, 2014 updated by: National Cancer Institute (NCI)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. 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:

I. 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

Study Type

Interventional

Enrollment (Actual)

140

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Stanford, California, United States, 94305
    - Stanford University Hospitals and Clinics
- Colorado
  - Aurora, Colorado, United States, 80012
    - The Medical Center of Aurora
  - Boulder, Colorado, United States, 80301
    - Boulder Community Hospital
  - Colorado Springs, Colorado, United States, 80907
    - Penrose-Saint Francis Healthcare
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, United States, 80218
    - Presbyterian - Saint Lukes Medical Center - Health One
  - Denver, Colorado, United States, 80220
    - Rose Medical Center
  - Denver, Colorado, United States, 80218
    - Exempla Saint Joseph Hospital
  - Denver, Colorado, United States, 80224-2522
    - Colorado Cancer Research Program CCOP
  - Englewood, Colorado, United States, 80113
    - Swedish Medical Center
  - Grand Junction, Colorado, United States, 81502
    - Saint Mary's Hospital and Regional Medical Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Lakewood, Colorado, United States, 80228
    - Saint Anthony Hospital
  - Lone Tree, Colorado, United States, 80124
    - Sky Ridge Medical Center
  - Longmont, Colorado, United States, 80501
    - Longmont United Hospital
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Pueblo, Colorado, United States, 81004
    - Saint Mary Corwin Medical Center
  - Thornton, Colorado, United States, 80229
    - North Suburban Medical Center
  - Wheat Ridge, Colorado, United States, 80033
    - Exempla Lutheran Medical Center
- Connecticut
  - Danbury, Connecticut, United States, 06810
    - Danbury Hospital
  - Hartford, Connecticut, United States, 06105
    - Saint Francis Hospital and Medical Center
  - Manchester, Connecticut, United States, 06040
    - Manchester Memorial Hospital
- Georgia
  - Macon, Georgia, United States, 31208
    - Medical Center of Central Georgia
- Illinois
  - Bloomington, Illinois, United States, 61701
    - Saint Joseph Medical Center
  - Bloomington, Illinois, United States, 61701
    - Illinois CancerCare-Bloomington
  - Canton, Illinois, United States, 61520
    - Illinois CancerCare-Canton
  - Canton, Illinois, United States, 61520
    - Graham Hospital Association
  - Carthage, Illinois, United States, 62321
    - Illinois CancerCare-Carthage
  - Carthage, Illinois, United States, 62321
    - Memorial Hospital
  - Eureka, Illinois, United States, 61530
    - Illinois CancerCare-Eureka
  - Eureka, Illinois, United States, 61530
    - Eureka Hospital
  - Evanston, Illinois, United States, 60201
    - Evanston CCOP-NorthShore University HealthSystem
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare Galesburg
  - Havana, Illinois, United States, 62644
    - Mason District Hospital
  - Havana, Illinois, United States, 62644
    - Illinois CancerCare-Havana
  - Hinsdale, Illinois, United States, 60521
    - Hinsdale Hematology Oncology Associates Incorporated
  - Kewanee, Illinois, United States, 61443
    - Illinois CancerCare-Kewanee Clinic
  - Macomb, Illinois, United States, 61455
    - Illinois CancerCare-Macomb
  - Macomb, Illinois, United States, 61455
    - Mcdonough District Hospital
  - Moline, Illinois, United States, 61265
    - Garneau, Stewart C MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Porubcin, Michael MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Spector, David MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Trinity Medical Center
  - Moline, Illinois, United States, 61265
    - Sharis, Christine M MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Stoffel, Thomas J MD (UIA Investigator)
  - Monmouth, Illinois, United States, 61462
    - Illinois CancerCare-Monmouth
  - Monmouth, Illinois, United States, 61462
    - Holy Family Medical Center
  - Normal, Illinois, United States, 61761
    - Community Cancer Center Foundation
  - Normal, Illinois, United States, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, United States, 61761
    - Illinois CancerCare-Community Cancer Center
  - Ottawa, Illinois, United States, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Ottawa, Illinois, United States, 61350
    - Ottawa Regional Hospital and Healthcare Center
  - Pekin, Illinois, United States, 61554
    - Pekin Cancer Treatment Center
  - Pekin, Illinois, United States, 61554
    - Pekin Hospital
  - Pekin, Illinois, United States, 61603
    - Illinois CancerCare-Pekin
  - Peoria, Illinois, United States, 61637
    - OSF Saint Francis Medical Center
  - Peoria, Illinois, United States, 61615
    - Illinois CancerCare-Peoria
  - Peoria, Illinois, United States, 61614
    - Proctor Hospital
  - Peoria, Illinois, United States, 61603
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, United States, 61615
    - Illinois Oncology Research Association CCOP
  - Peru, Illinois, United States, 61354
    - Illinois CancerCare-Peru
  - Peru, Illinois, United States, 61354
    - Illinois Valley Hospital
  - Princeton, Illinois, United States, 61356
    - Illinois CancerCare-Princeton
  - Princeton, Illinois, United States, 61356
    - Perry Memorial Hospital
  - Spring Valley, Illinois, United States, 61362
    - Saint Margaret's Hospital
  - Spring Valley, Illinois, United States, 61362
    - Illinois CancerCare-Spring Valley
- Indiana
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - Indianapolis, Indiana, United States, 46202
    - Indiana University Medical Center
  - Indianapolis, Indiana, United States, 46202
    - Richard L. Roudebush Veterans Affairs Medical Center
  - Indianapolis, Indiana, United States, 46202
    - Wishard Hospital
  - Kokomo, Indiana, United States, 46904
    - Community Howard Regional Health
  - La Porte, Indiana, United States, 46350
    - Indiana University Health La Porte Hospital
  - Lafayette, Indiana, United States, 47904
    - IU Health Arnett
  - Mishawaka, Indiana, United States, 46545-1470
    - Saint Joseph Regional Medical Center-Mishawaka
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46628
    - Northern Indiana Cancer Research Consortium
- Iowa
  - Bettendorf, Iowa, United States, 52722
    - Constantinou, Costas L MD (UIA Investigator)
  - Cedar Rapids, Iowa, United States, 52403
    - Mercy Hospital
  - Cedar Rapids, Iowa, United States, 52403
    - Oncology Associates at Mercy Medical Center
  - Cedar Rapids, Iowa, United States, 52403
    - Cedar Rapids Oncology Association
  - Sioux City, Iowa, United States, 51104
    - Saint Luke's Regional Medical Center
  - Sioux City, Iowa, United States, 51101
    - Siouxland Hematology Oncology Associates
  - Sioux City, Iowa, United States, 51104
    - Mercy Medical Center-Sioux City
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas - El Dorado
  - Fort Scott, Kansas, United States, 66701
    - Cancer Center of Kansas - Fort Scott
  - Independence, Kansas, United States, 67301
    - Cancer Center of Kansas-Independence
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas-Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, United States, 67901
    - Cancer Center of Kansas-Liberal
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas - Newton
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas - Parsons
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas - Pratt
  - Salina, Kansas, United States, 67401
    - Cancer Center of Kansas - Salina
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas - Wellington
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita, Kansas, United States, 67208
    - Associates In Womens Health
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas - Main Office
  - Wichita, Kansas, United States, 67214
    - Via Christi Regional Medical Center
  - Wichita, Kansas, United States, 67214
    - Wichita CCOP
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas - Winfield
- Maryland
  - Baltimore, Maryland, United States, 21204
    - Greater Baltimore Medical Center
- Michigan
  - Adrian, Michigan, United States, 49221
    - Bixby Medical Center
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center
  - Ann Arbor, Michigan, United States, 48106-0995
    - Saint Joseph Mercy Hospital
  - Ann Arbor, Michigan, United States, 48106
    - Michigan Cancer Research Consortium Community Clinical Oncology Program
  - Dearborn, Michigan, United States, 48124
    - Oakwood Hospital
  - Detroit, Michigan, United States, 48236
    - Saint John Hospital and Medical Center
  - Escanaba, Michigan, United States, 49431
    - Green Bay Oncology - Escanaba
  - Flint, Michigan, United States, 48502
    - Hurley Medical Center
  - Flint, Michigan, United States, 48532
    - Genesys Regional Medical Center-West Flint Campus
  - Iron Mountain, Michigan, United States, 49801
    - Green Bay Oncology - Iron Mountain
  - Jackson, Michigan, United States, 49201
    - Allegiance Health
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49001
    - Borgess Medical Center
  - Lansing, Michigan, United States, 48912
    - Sparrow Hospital
  - Livonia, Michigan, United States, 48154
    - Saint Mary Mercy Hospital
  - Monroe, Michigan, United States, 48162
    - Mercy Memorial Hospital
  - Monroe, Michigan, United States, 48162
    - Community Cancer Center of Monroe
  - Pontiac, Michigan, United States, 48341-2985
    - Saint Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Saint Joseph Mercy Port Huron
  - Saginaw, Michigan, United States, 48601
    - Saint Mary's of Michigan
  - Saint Joseph, Michigan, United States, 49085
    - Marie Yeager Cancer Center
  - St. Joseph, Michigan, United States, 49085
    - Lakeland Hospital
  - Warren, Michigan, United States, 48093
    - Saint John Macomb-Oakland Hospital
- Minnesota
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy Hospital
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Saint Mary's Medical Center
  - Duluth, Minnesota, United States, 55805
    - Miller-Dwan Hospital
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Duluth Clinic CCOP
  - Edina, Minnesota, United States, 55435
    - Fairview-Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Unity Hospital
  - Maplewood, Minnesota, United States, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, United States, 55407
    - Abbott-Northwestern Hospital
  - Robbinsdale, Minnesota, United States, 55422
    - North Memorial Medical Health Center
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Louis Park, Minnesota, United States, 55416
    - Metro-Minnesota CCOP
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Shakopee, Minnesota, United States, 55379
    - Saint Francis Regional Medical Center
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology and Hematology PA-Woodbury
- Nebraska
  - Lincoln, Nebraska, United States, 68510
    - Nebraska Cancer Research Center
  - Omaha, Nebraska, United States, 68124
    - Alegent Health Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68122
    - Alegent Health Immanuel Medical Center
  - Omaha, Nebraska, United States, 68131
    - Creighton University Medical Center
  - Omaha, Nebraska, United States, 68106
    - Missouri Valley Cancer Consortium CCOP
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89106
    - Nevada Cancer Research Foundation CCOP
- New Jersey
  - Flemington, New Jersey, United States, 08822
    - Hunterdon Medical Center
  - Mount Holly, New Jersey, United States, 08060
    - Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
  - Newark, New Jersey, United States, 07112
    - Newark Beth Israel Medical Center
  - Voorhees, New Jersey, United States, 08043
    - Virtua West Jersey Hospital Voorhees
- New York
  - Albany, New York, United States, 12208
    - New York Oncology Hematology PC -Albany Medical Center
  - Albany, New York, United States, 12206
    - New York Oncology Hematology PC - Albany
  - Amsterdam, New York, United States, 12010
    - New York Oncology Hematology PC - Amsterdam
  - Hudson, New York, United States, 12534
    - New York Oncology Hematology PC-Hudson
  - Latham, New York, United States, 12110
    - New York Oncology Hematology PC - Latham
  - Rexford, New York, United States, 12148
    - New York Oncology Hematology PC - Rexford
  - Troy, New York, United States, 12180
    - New York Oncology Hematology PC - Troy
- Ohio
  - Akron, Ohio, United States, 44304
    - Summa Akron City Hospital/Cooper Cancer Center
  - Bellefontaine, Ohio, United States, 43311
    - Mary Rutan Hospital
  - Bowling Green, Ohio, United States, 43402
    - Toledo Clinic Cancer Centers-Bowling Green
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cleveland, Ohio, United States, 44106
    - Case Western Reserve University
  - Clyde, Ohio, United States, 43410
    - North Coast Cancer Care-Clyde
  - Columbus, Ohio, United States, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health Center West
  - Columbus, Ohio, United States, 43215
    - Columbus CCOP
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Elyria, Ohio, United States, 44035
    - Hematology Oncology Center Incorporated
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Marietta, Ohio, United States, 45750
    - Marietta Memorial Hospital
  - Maumee, Ohio, United States, 43537
    - Toledo Clinic Cancer Centers-Maumee
  - Maumee, Ohio, United States, 43537
    - Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
  - Maumee, Ohio, United States, 43537
    - Saint Luke's Hospital
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Hospital
  - Norwalk, Ohio, United States, 44857
    - Fisher-Titus Medical Center
  - Orange Village, Ohio, United States, 44122
    - UHHS-Chagrin Highlands Medical Center
  - Oregon, Ohio, United States, 43616
    - Saint Charles Hospital
  - Oregon, Ohio, United States, 43616
    - Toledo Clinic Cancer Centers-Oregon
  - Sandusky, Ohio, United States, 44870
    - North Coast Cancer Care
  - Springfield, Ohio, United States, 45505
    - Springfield Regional Medical Center
  - Sylvania, Ohio, United States, 43560
    - Flower Hospital
  - Tiffin, Ohio, United States, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, United States, 43608
    - Saint Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic Cancer Centers-Toledo
  - Toledo, Ohio, United States, 43614
    - University of Toledo
  - Toledo, Ohio, United States, 43617
    - Toledo Community Hospital Oncology Program CCOP
  - Toledo, Ohio, United States, 43606
    - The Toledo Hospital/Toledo Children's Hospital
  - Toledo, Ohio, United States, 43623
    - Mercy Saint Anne Hospital
  - Wauseon, Ohio, United States, 43567
    - Fulton County Health Center
  - Westerville, Ohio, United States, 43081
    - Saint Ann's Hospital
  - Westlake, Ohio, United States, 44145
    - UHHS-Westlake Medical Center
  - Zanesville, Ohio, United States, 43701
    - Genesis HealthCare System
- Oklahoma
  - Tulsa, Oklahoma, United States, 74136
    - Natalie Warren Bryant Cancer Center at Saint Francis
- Pennsylvania
  - Bryn Mawr, Pennsylvania, United States, 19010
    - Bryn Mawr Hospital
  - Danville, Pennsylvania, United States, 17822-2001
    - Geisinger Medical Center
  - Hazleton, Pennsylvania, United States, 18201
    - Geisinger Medical Center-Cancer Center Hazelton
  - Lancaster, Pennsylvania, United States, 17604
    - Lancaster General Hospital
  - Paoli, Pennsylvania, United States, 19301
    - Paoli Memorial Hospital
  - Philadelphia, Pennsylvania, United States, 19141
    - Albert Einstein Medical Center
  - Philadelphia, Pennsylvania, United States, 19104
    - Abramson Cancer Center of the University of Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15232
    - University of Pittsburgh
  - Pottstown, Pennsylvania, United States, 19464
    - Pottstown Memorial Medical Center
  - Scranton, Pennsylvania, United States, 18510
    - Scranton Hematology Oncology
  - Scranton, Pennsylvania, United States, 18501
    - Mercy Hospital
  - State College, Pennsylvania, United States, 16801
    - Geisinger Medical Group
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Geisinger Wyoming Valley
  - Wynnewood, Pennsylvania, United States, 19096
    - Lankenau Hospital
  - Wynnewood, Pennsylvania, United States, 19096
    - Mainline Health CCOP
- Tennessee
  - Franklin, Tennessee, United States, 37067
    - Vanderbilt-Ingram Cancer Center Cool Springs
  - Nashville, Tennessee, United States, 37203
    - Nashville Oncology Associates PC
- Texas
  - Temple, Texas, United States, 76508
    - Scott and White Memorial Hospital
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia
  - Fredericksburg, Virginia, United States, 22401
    - Fredericksburg Oncology Inc
- West Virginia
  - Charleston, West Virginia, United States, 25304
    - West Virginia University Charleston
  - Wheeling, West Virginia, United States, 26003
    - Wheeling Hospital
- Wisconsin
  - Appleton, Wisconsin, United States, 54911-3496
    - Fox Valley Hematology and Oncology
  - Chippewa Falls, Wisconsin, United States, 54729
    - Marshfield Clinic-Chippewa Center
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Clinic Cancer Center at Sacred Heart
  - Green Bay, Wisconsin, United States, 54301
    - Saint Vincent Hospital
  - Green Bay, Wisconsin, United States, 54303
    - Green Bay Oncology Limited at Saint Mary's Hospital
  - Green Bay, Wisconsin, United States, 54303
    - Saint Mary's Hospital
  - Green Bay, Wisconsin, United States, 54301-3526
    - Green Bay Oncology at Saint Vincent Hospital
  - Johnson Creek, Wisconsin, United States, 53038
    - UW Cancer Center Johnson Creek
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Hospital and Clinics
  - Madison, Wisconsin, United States, 53715
    - UW Health Oncology - 1 South Park
  - Manitowoc, Wisconsin, United States, 54221
    - Holy Family Memorial Hospital
  - Marinette, Wisconsin, United States, 54143
    - Bay Area Medical Center
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Clinic
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic-Minocqua Center
  - Oconto Falls, Wisconsin, United States, 54154
    - Green Bay Oncology - Oconto Falls
  - Rhinelander, Wisconsin, United States, 54501
    - Marshfield Clinic at James Beck Cancer Center
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Clinic-Rice Lake Center
  - Stevens Point, Wisconsin, United States, 54481
    - Marshfield Clinic Cancer Care at Saint Michael's Hospital
  - Sturgeon Bay, Wisconsin, United States, 54235
    - Green Bay Oncology - Sturgeon Bay
  - Wausau, Wisconsin, United States, 54401
    - Marshfield Clinic-Wausau Center
  - Weston, Wisconsin, United States, 54476
    - Marshfield Clinic - Weston Center
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Marshfield Clinic - Wisconsin Rapids Center
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Riverview Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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
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

Exclusion criteria:

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
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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm I (carboplatin, paclitaxel, cetuximab) Patients 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.	Drug: paclitaxel Given IV Other Names: Taxol Anzatax Asotax TAX Drug: carboplatin Given IV Other Names: Carboplat CBDCA JM-8 Paraplatin Paraplat Biological: cetuximab Given IV Other Names: C225 IMC-C225 C225 monoclonal antibody MOAB C225 monoclonal antibody C225
EXPERIMENTAL: Arm II (carboplatin, paclitaxel, cixutumumab) 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.	Drug: paclitaxel Given IV Other Names: Taxol Anzatax Asotax TAX Drug: carboplatin Given IV Other Names: Carboplat CBDCA JM-8 Paraplatin Paraplat Biological: cixutumumab Given IV Other Names: anti-IGF-1R recombinant monoclonal antibody IMC-A12 IMC-A12
EXPERIMENTAL: Arm III (carboplatin, paclitaxel, cetuximab, cixutumumab) 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.	Drug: paclitaxel Given IV Other Names: Taxol Anzatax Asotax TAX Drug: carboplatin Given IV Other Names: Carboplat CBDCA JM-8 Paraplatin Paraplat Biological: cetuximab Given IV Other Names: C225 IMC-C225 C225 monoclonal antibody MOAB C225 monoclonal antibody C225 Biological: cixutumumab Given IV Other Names: anti-IGF-1R recombinant monoclonal antibody IMC-A12 IMC-A12

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3	Overall survival is defined as time from registration to death from any cause.	assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3
Response Rate 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	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.	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

Principal Investigator: Nasser Hanna, Indiana University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

August 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

September 29, 2009

First Submitted That Met QC Criteria

September 29, 2009

First Posted (ESTIMATE)

September 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 26, 2014

Last Update Submitted That Met QC Criteria

September 19, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

NCI-2011-01976
U10CA021115 (U.S. NIH Grant/Contract)
E4508 (OTHER: Eastern Cooperative Oncology Group)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start

Primary Completion (ACTUAL)

Study Completion (ACTUAL)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (ESTIMATE)

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers