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Phase II Study of C225 (Cetuximab) for the Treatment of Patients With Advanced Bronchioalveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

Phase II Study of C225 (Cetuximab) for the Treatment of Patients With Advanced Bronchioalveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features


OBJECTIVES:

Primary

- Determine the objective response rate in patients with recurrent or stage IIIB or IV
bronchoalveolar carcinoma (BAC) or adenocarcinoma of the lung with BAC features treated
with cetuximab.

Secondary

- Determine the overall survival and time to progression in patients treated with this
drug.

- Determine the toxic effects of this drug in these patients.

- Correlate expression of total and phosphorylated epidermal growth factor receptor
(EGFR), total and phosphorylated AKT3, and total and phosphorylated MAPKinase with
response in patients treated with this drug.

- Determine whether the presence of polymorphisms or mutations in the EGFR gene
influences response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours once on days 1, 8, 15, and 22. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.

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

ACTUAL ACCRUAL: A total of 72 patients were accrued for this study.

Inclusion Criteria


INCLUSION CRITERIA:

- Histologically or cytologically confirmed bronchoalveolar carcinoma (BAC) or
adenocarcinoma of the lung with BAC features meeting 1 of the following stage
criteria:

- Stage IIIB disease (with pleural or pericardial effusion)

- Stage IV disease

- Recurrent disease

- Measurable disease

- Tumor tissue available from biopsy

- Age of 18 and over

- ECOG performance status of 0-2

- Life expectancy greater than 3 months

- White blood cell (WBC) ≥ 3,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Bilirubin normal

- Aspartate aminotransferase (AST) and/or alanine aminotranferease (ALT) ≤ 2.5 times
upper limit of normal

- Creatinine normal OR Creatinine clearance ≥ 60 mL/min

- No more than 1 prior chemotherapy regimen for advanced BAC

- More than 3 years since prior chemotherapy for other malignancies

- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) for
this malignancy and recovered

- HIV-positive patients are eligible provided the following criteria are met:

- CD4 count ≥ 100/mm^3

- Undetectable viral load within the past 3 months

- Receiving a stable antiretroviral regimen for ≥ 4 weeks before study entry

- Fertile patients must use effective contraception

- At least 2 weeks since prior radiotherapy and recovered

EXCLUSION CRITERIA:

- Untreated brain metastases

- Patients with stable brain metastases ≥ 4 weeks after external beam radiotherapy
to the brain are eligible

- Acute hepatitis

- Symptomatic congestive heart failure

- Uncontrolled hypertension

- Unstable angina pectoris

- Cardiac arrhythmia

- Pregnant or nursing

- Prior allergic reaction to chimerized or murine monoclonal antibody therapy

- Documented presence of human anti-mouse antibodies

- Ongoing or active infection

- Psychiatric illness or social situation that would preclude study compliance

- Other uncontrolled illness

- Prior cetuximab

- Concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

- Other prior known epidermal growth factor receptor inhibitors (e.g., gefitinib or
erlotinib)

- Other concurrent investigational agents

- Other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate (Proportion of Patients With Objective Response)

Outcome Description:

Response was evaluated using RECIST 1.0 criteria. Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.

Outcome Time Frame:

Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years

Safety Issue:

No

Principal Investigator

Suresh Ramalingam, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Emory Winship Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000409755

NCT ID:

NCT00103207

Start Date:

August 2005

Completion Date:

August 2012

Related Keywords:

  • Lung Cancer
  • bronchioalveolar carcinoma (BAC)
  • adenocarcinoma with BAC features
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • cetuximab
  • Adenocarcinoma
  • Adenocarcinoma, Bronchiolo-Alveolar
  • Lung Neoplasms

Name

Location

CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
Aurora Presbyterian HospitalAurora, Colorado  80012
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
CCOP - Colorado Cancer Research ProgramDenver, Colorado  80224-2522
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical CenterGrand Junction, Colorado  81502
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
St. Mary - Corwin Regional Medical CenterPueblo, Colorado  81004
North Suburban Medical CenterThornton, Colorado  80229
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's HospitalSt Paul, Minnesota  55102
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
HealthEast Cancer Care at Woodwinds Health CampusWoodbury, Minnesota  55125
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
St. Rita's Medical CenterLima, Ohio  45801
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Mercy Hospital Cancer Center - ScrantonScranton, Pennsylvania  18501
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
CCOP - Scott and White HospitalTemple, Texas  76508
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
St. Vincent Mercy Medical CenterToledo, Ohio  43608
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
Hunterdon Regional Cancer Center at Hunterdon Medical CenterFlemington, New Jersey  08822
Lewistown HospitalLewistown, Pennsylvania  17044
Mount Nittany Medical CenterState College, Pennsylvania  16803
North Colorado Medical CenterGreeley, Colorado  80631
McKee Medical CenterLoveland, Colorado  80539
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
Southwest Medical CenterLiberal, Kansas  67901
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Community Cancer Center of MonroeMonroe, Michigan  48162
Booker Cancer Center at Riverview Medical CenterRed Bank, New Jersey  07701
Wood County Oncology CenterBowling Green, Ohio  43402
Lima Memorial HospitalLima, Ohio  45804
St. Luke's HospitalMaumee, Ohio  43537
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Toledo Clinic - OregonOregon, Ohio  43616
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
Fulton County Health CenterWauseon, Ohio  43567
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
St. Anthony Central HospitalDenver, Colorado  80204-1335
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Morton Hospital & Medical CenterTaunton, Massachusetts  02780
St. Joseph Medical CenterReading, Pennsylvania  19604
McFarland Clinic, PCAmes, Iowa  50010
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Foote Memorial HospitalJackson, Michigan  49201
Haematology-Oncology Associates of Ohio and Michigan, PCLambertville, Michigan  48144
St. Mary Mercy HospitalLivonia, Michigan  48154
Mercy Memorial Hospital - MonroeMonroe, Michigan  48162
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Hematology Oncology CenterElyria, Ohio  44035
Flower Hospital Cancer CenterSylvania, Ohio  43560
St. Luke's Cancer Network at St. Luke's HospitalBethlehem, Pennsylvania  18015
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Hematology and Oncology Associates of Northeastern PennsylvaniaScranton, Pennsylvania  18510
Fredericksburg Oncology, IncorporatedFredericksburg, Virginia  22401
Center for Cancer Treatment & Prevention at Sacred Heart HospitalEau Claire, Wisconsin  54701
Marshfield Clinic Cancer Care at Regional Cancer CenterEau Claire, Wisconsin  54701
Saint Joseph's HospitalMarshfield, Wisconsin  54449
Marshfield Clinic - Lakeland CenterMinocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's HospitalRhinelander, Wisconsin  54501
Saint Michael's Hospital Cancer CenterStevens Point, Wisconsin  54481
Marshfield Clinic - Wausau CenterWausau, Wisconsin  54401
Marshfield Clinic - Wisconsin Rapids CenterWisconsin Rapids, Wisconsin  54494
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
University of Wisconcin Cancer Center at Aspirus Wausau HospitalWausau, Wisconsin  54401
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
CCOP - Main Line HealthWynnewood, Pennsylvania  19096
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main CampusBoca Raton, Florida  33486