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A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMCA12 for Patients With Extensive Stage Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Extensive Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer

Thank you

Trial Information

A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMCA12 for Patients With Extensive Stage Small Cell Lung Cancer


PRIMARY OBJECTIVES:

I. To evaluate the progression-free survival of patients with extensive stage small cell
lung cancer treated with cisplatin and etoposide with or without Hedgehog antagonist
GDC-0449 or cixutumumab.

SECONDARY OBJECTIVES:

I. To evaluate the response rate in patients treated with these regimens. II. To evaluate
the overall survival of patients treated with these regimens. III. To evaluate the toxicity
of these regimens in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to gender. Patients
are randomized to 1 of 3 treatment arms.

ARM I: Patients receive cisplatin IV over 1-2 hours on day 1 and etoposide phosphate IV over
1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of
disease progression or unacceptable toxicity.

ARM II: Patients receive cisplatin and etoposide phosphate as in arm I and oral Hedgehog
antagonist GDC-0449 once daily on days 1-21. Treatment repeats every 21 days for 4 courses
in the absence of disease progression or unacceptable toxicity. Patients then receive
Hedgehog antagonist GDC-0449 alone once daily in the absence of disease progression or
unacceptable toxicity.

ARM III: Patients receive cisplatin and etoposide phosphate as in arm I and cixutumumab IV
over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the
absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab
alone once weekly in the absence of disease progression or unacceptable toxicity.

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


Inclusion Criteria:



- Histologically or cytologically confirmed small cell lung cancer (SCLC)

- Extensive stage disease, as defined by any of the following criteria:

- Extrathoracic metastatic disease

- Malignant pleural effusion

- Bilateral or contralateral supraclavicular adenopathy

- Measurable disease based on RECIST criteria

- CNS metastases allowed provided the patient has completed a course of CNS
radiotherapy and has stable neurologic function for ≥ 28 days prior to randomization

- Prophylactic cranial irradiation allowed in those who have a response (in the
absence of progressive disease)

- ECOG performance status 0-1

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Leukocyte count ≥ 3,000/mm^3

- Hemoglobin ≥ 9 g/dL

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST/ALT ≤ 3 times ULN (≤ 5 times ULN if elevations are due to liver metastases)

- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min

- Fasting serum glucose < 120 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective double-method contraception for ≥ 28 days before,
during, and for ≥ 12 months after completion of study treatment

- No concurrent uncontrolled illness including, but not limited to, any of the
following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Uncontrolled cardiac arrhythmia

- Psychiatric illness or social situation that would limit compliance with study
requirements

- No poorly controlled diabetes mellitus

- History of diabetes mellitus allowed provided blood glucose is normal and the
patient is on a stable dietary or therapeutic regimen

- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to Hedgehog antagonist GDC-0449, cixutumumab, or other study
agents

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No prior chemotherapy or biologic therapy for SCLC

- No prior therapy with other agents targeting the IGFR or the Hedgehog signaling
pathway

- No prior irradiation to the only site of measurable or evaluable disease unless that
site had subsequent evidence of progression

- Prior palliative radiotherapy to other sites of disease allowed

- More than 14 days since prior radiotherapy (28 days for radiotherapy to the CNS) and
recovered

- More than 4 weeks since prior major surgery or hormonal therapy (other than
replacement therapy) and recovered

- No other concurrent investigational or anticancer agents

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Time from randomization to death or disease progression, whichever occurs first, assessed up to 3 years

Safety Issue:

No

Principal Investigator

Chandra Belani

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-01917

NCT ID:

NCT00887159

Start Date:

July 2009

Completion Date:

Related Keywords:

  • Extensive Stage Small Cell Lung Cancer
  • Recurrent Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Albert Einstein College of MedicineBronx, New York  10461
Johns Hopkins UniversityBaltimore, Maryland  21205
Hurley Medical CenterFlint, Michigan  48503
Boulder Community HospitalBoulder, Colorado  80301-9019
Porter Adventist HospitalDenver, Colorado  80210
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
North Suburban Medical CenterThornton, Colorado  80229
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Fairview Ridges HospitalBurnsville, Minnesota  55337
Hutchinson Area Health CareHutchinson, Minnesota  55350
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Avera Cancer InstituteSioux Falls, South Dakota  57105
Marshfield ClinicMarshfield, Wisconsin  54449
Stanford UniversityStanford, California  94305
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Lehigh Valley HospitalAllentown, Pennsylvania  18103
York HospitalYork, Pennsylvania  17315
Waukesha Memorial HospitalWaukesha, Wisconsin  53188
Rush University Medical CenterChicago, Illinois  60612-3824
Via Christi Regional Medical CenterWichita, Kansas  67214
Iowa Methodist Medical CenterDes Moines, Iowa  50309
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Montefiore Medical CenterBronx, New York  10467-2490
Lewistown HospitalLewistown, Pennsylvania  17044
Mount Nittany Medical CenterState College, Pennsylvania  16803
North Colorado Medical CenterGreeley, Colorado  80631
McKee Medical CenterLoveland, Colorado  80539
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Adena Regional Medical CenterChillicothe, Ohio  54601
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Avera McKennan Hospital and University Health CenterSioux Falls, South Dakota  57105
Medical X-Ray CenterSioux Falls, South Dakota  57105
Memorial HospitalCarthage, Illinois  62321
Hematology and Oncology AssociatesChicago, Illinois  60611
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Proctor HospitalPeoria, Illinois  61614
Perry Memorial HospitalPrinceton, Illinois  61356
Community Cancer Center of MonroeMonroe, Michigan  48162
Creighton University Medical CenterOmaha, Nebraska  68131-2197
MeritCare Medical GroupFargo, North Dakota  58122
Wood County Oncology CenterBowling Green, Ohio  43402
Lima Memorial HospitalLima, Ohio  45804
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Mercy Hospital of TiffinTiffin, Ohio  44883
Fulton County Health CenterWauseon, Ohio  43567
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Eureka HospitalEureka, Illinois  61530
Mercy HospitalCoon Rapids, Minnesota  55433
Graham Hospital AssociationCanton, Illinois  61520
Holy Family Medical CenterDes Plaines, Illinois  60016
Hematology Oncology Associates of Illinois-Highland ParkHighland Park, Illinois  60035
Trinity Medical CenterMoline, Illinois  61265-1291
Pekin HospitalPekin, Illinois  61554
Medical Oncology and Hematology AssociatesDes Moines, Iowa  50309
Ottumwa Regional Health CenterOttumwa, Iowa  52501
Bixby Medical CenterAdrian, Michigan  49221
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Fairview-Southdale HospitalEdina, Minnesota  55435
Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Regions HospitalSaint Paul, Minnesota  55101
Saint Francis Regional Medical CenterShakopee, Minnesota  55379
Rice Memorial HospitalWillmar, Minnesota  56201
Saint Luke's HospitalMaumee, Ohio  43537
Lancaster General HospitalLancaster, Pennsylvania  17604-3555
Geisinger Medical GroupState College, Pennsylvania  16801
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Lawrence Memorial HospitalLawrence, Kansas  66044
Mary Rutan HospitalBellefontaine, Ohio  43311
Knox Community HospitalMount Vernon, Ohio  43050
Fisher-Titus Medical CenterNorwalk, Ohio  44857
Marshfield Clinic Cancer Care at Regional Cancer CenterEau Claire, Wisconsin  54701
Marshfield Clinic - Weston CenterWeston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids CenterWisconsin Rapids, Wisconsin  54494
Longmont United HospitalLongmont, Colorado  80501
Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404
Mayo Clinic in FloridaJacksonville, Florida  32224
Memorial Medical CenterSpringfield, Illinois  62781
University of VirginiaCharlottesville, Virginia  22908
Vanderbilt UniversityNashville, Tennessee  37232-6305
Northwestern UniversityChicago, Illinois  60611
Elmhurst Memorial HospitalElmhurst, Illinois  60126
Hennepin County Medical CenterMinneapolis, Minnesota  
Case Western Reserve UniversityCleveland, Ohio  44106
Emory UniversityAtlanta, Georgia  30322
Albert Einstein Medical CenterPhiladelphia, Pennsylvania  19141
Toledo ClinicOregon, Ohio  43616
Riverside Methodist HospitalColumbus, Ohio  43214
Licking Memorial HospitalNewark, Ohio  43055-2899
Columbus CCOPColumbus, Ohio  43206
Presbyterian - Saint Lukes Medical Center - Health OneDenver, Colorado  80218
Wichita CCOPWichita, Kansas  67214-3882
Alegent Health Immanuel Medical CenterOmaha, Nebraska  68122
Alegent Health Bergan Mercy Medical CenterOmaha, Nebraska  68124
Flower HospitalSylvania, Ohio  43560-2197
Metro-Minnesota CCOPSt. Louis Park, Minnesota  
Lakeview HospitalStillwater, Minnesota  55082
Thomas Jefferson University HospitalPhiladelphia, Pennsylvania  19131
Decatur Memorial HospitalDecatur, Illinois  62526
Penn State Milton S Hershey Medical CenterHershey, Pennsylvania  17033
Butler Memorial HospitalButler, Pennsylvania  16001
The Medical Center of AuroraAurora, Colorado  80012
Penrose-Saint Francis HealthcareColorado Springs, Colorado  80907
Saint Anthony Central HospitalDenver, Colorado  80204
Exempla Saint Joseph HospitalDenver, Colorado  80218
Colorado Cancer Research Program CCOPDenver, Colorado  80224-2522
Saint Mary's Hospital and Regional Medical CenterGrand Junction, Colorado  81502
Saint Mary Corwin Medical CenterPueblo, Colorado  81004
Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
The Hospital of Central ConnecticutNew Britain, Connecticut  06050
Veterans Administration Medical CenterDecatur, Georgia  30033
Saint Joseph's-Candler Health SystemSavannah, Georgia  31405
John H Stroger Jr Hospital of Cook CountyChicago, Illinois  60612-3785
Evanston CCOP-NorthShore University HealthSystemEvanston, Illinois  60201
Provena Saint Mary's HospitalKankakee, Illinois  60901
North Shore Hematology OncologyLibertyville, Illinois  60048
Stoffel, Thomas J MD (UIA Investigator)Moline, Illinois  61265
Garneau, Stewart C MD (UIA Investigator)Moline, Illinois  61265
Sharis, Christine M MD (UIA Investigator)Moline, Illinois  61265
Porubcin, Michael MD (UIA Investigator)Moline, Illinois  61265
Community Cancer Center FoundationNormal, Illinois  61761
Illinois CancerCare-Ottawa ClinicOttawa, Illinois  61350
Ottawa Regional Hospital and Healthcare CenterOttawa, Illinois  61350
Pekin Cancer Treatment CenterPekin, Illinois  61554
Illinois Oncology Research Association CCOPPeoria, Illinois  61615
Illinois CancerCare-PeoriaPeoria, Illinois  61615
Illinois Valley HospitalPeru, Illinois  61354
Hematology Oncology Associates of Illinois - SkokieSkokie, Illinois  60076
Saint Margaret's HospitalSpring Valley, Illinois  61362
McFarland ClinicAmes, Iowa  50010
Constantinou, Costas L MD (UIA Investigator)Bettendorf, Iowa  52722
Medical Oncology and Hematology Associates-West Des MoinesClive, Iowa  50325
Iowa Oncology Research Association CCOPDes Moines, Iowa  50309
Mercy CapitolDes Moines, Iowa  50307
Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des MoinesDes Moines, Iowa  50309
Mercy Medical Center - North IowaMason City, Iowa  50401
Mercy Medical Center-Sioux CitySioux City, Iowa  51104
Saint Luke's Regional Medical CenterSioux City, Iowa  51104
Siouxland Hematology - Oncology AssociatesSioux City, Iowa  51101
Cancer Center of Kansas - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-KingmanKingman, Kansas  67068
Cancer Center of Kansas - ParsonsParsons, Kansas  67357
Cancer Center of Kansas - PrattPratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas - Main OfficeWichita, Kansas  67214
Hickman Cancer CenterAdrian, Michigan  49221
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
Mercy Memorial HospitalMonroe, Michigan  48162
Saint Joseph Mercy OaklandPontiac, Michigan  48341-2985
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint Mary's of MichiganSaginaw, Michigan  48601
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Merit Care Clinic BemidjiBemidji, Minnesota  56601
Saint Mary's Medical CenterDuluth, Minnesota  55805
Miller-Dwan HospitalDuluth, Minnesota  55805
Unity HospitalFridley, Minnesota  55432
Saint John's Hospital - HealtheastMaplewood, Minnesota  55109
Minnesota Oncology Hematology PA-MaplewoodMaplewood, Minnesota  55109
North Memorial Medical Health CenterRobbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, Minnesota  55416
Minnesota Oncology and Hematology PA-WoodburyWoodbury, Minnesota  55125
Lincoln Medical Education Foundation Cancer Resource CenterLincoln, Nebraska  68510
Missouri Valley Cancer Consortium CCOPOmaha, Nebraska  68106
Nevada Cancer Research Foundation CCOPLas Vegas, Nevada  89106
Hunterdon Medical CenterFlemington, New Jersey  08822
Sparta Cancer Treatment CenterSparta, New Jersey  07871
New York University Langone Medical CenterNew York, New York  10016
Dickstein Cancer Treatment CenterWhite Plains, New York  10601
Meritcare HospitalFargo, North Dakota  58122
Aultman Health FoundationCanton, Ohio  44710
Doctors HospitalColumbus, Ohio  43228
Grant Medical CenterColumbus, Ohio  43215
Mount Carmel Health Center WestColumbus, Ohio  43222
Hematology Oncology Center IncorporatedElyria, Ohio  44035
Marietta Memorial HospitalMarietta, Ohio  45750
Toledo Radiation Oncology at Northwest Ohio Onocolgy CenterMaumee, Ohio  43537
Saint Charles HospitalOregon, Ohio  43616
North Coast Cancer CareSandusky, Ohio  44870
Toledo Community Hospital Oncology Program CCOPToledo, Ohio  43617
Mercy Cancer Center at Saint Anne Mercy HospitalToledo, Ohio  43623
University of ToledoToledo, Ohio  43614
The Toledo HospitalToledo, Ohio  43606
Saint Vincent Mercy Medical CenterToledo, Ohio  43608
Saint Ann's HospitalWesterville, Ohio  43081
Genesis HealthCare SystemZanesville, Ohio  43701
Ephrata Cancer CenterEphrata, Pennsylvania  17522
Hematology and Oncology Associates of North East PennsylvaniaScranton, Pennsylvania  18508
Scranton Hematology OncologyScranton, Pennsylvania  18510
Mercy HospitalScranton, Pennsylvania  18501
Geisinger Wyoming ValleyWilkes-Barre, Pennsylvania  18711
Sanford Cancer Center-Oncology ClinicSioux Falls, South Dakota  57104
Sanford University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
Fredericksburg Oncology IncFredericksburg, Virginia  22401
Wheeling HospitalWheeling, West Virginia  26003
Dean Hematology and Oncology ClinicMadison, Wisconsin  53717
Marshfield Clinic-Minocqua CenterMinocqua, Wisconsin  54548
Oconomowoc Memorial Hospital-ProHealth Care IncOconomowoc, Wisconsin  53066-3896
Marshfield Clinic at James Beck Cancer CenterRhinelander, Wisconsin  54501
Marshfield Clinic-Rice Lake CenterRice Lake, Wisconsin  54868
Stony Brook University Medical CenterStony Brook, New York  11794
Illinois CancerCare-BloomingtonBloomington%, Illinois  61701
Illinois CancerCare-CantonCanton, Illinois  61520
Illinois CancerCare-CarthageCarthage, Illinois  62321
Illinois CancerCare-EurekaEureka, Illinois  61530
Illinois CancerCare-HavanaHavana, Illinois  62644
Illinois CancerCare-Kewanee ClinicKewanee, Illinois  61443
Illinois CancerCare-MacombMacomb, Illinois  61455
Illinois CancerCare-MonmouthMonmouth, Illinois  61462
Illinois CancerCare-Community Cancer CenterNormal, Illinois  61761
Illinois CancerCare-PekinPekin, Illinois  61603
Illinois CancerCare-PeruPeru, Illinois  61354
Illinois CancerCare-PrincetonPrinceton, Illinois  61356
Illinois CancerCare-Spring ValleySpring Valley, Illinois  61362
Cancer Center of Kansas-LiberalLiberal, Kansas  67901
Hackensack University Medical CCOPHackensack, New Jersey  07601
North Coast Cancer Care-ClydeClyde, Ohio  43410
Community Health Partners Regional Medical CenterElyria, Ohio  44035
Saint Mary Medical and Regional Cancer CenterLanghorne, Pennsylvania  19047
Vanderbilt-Ingram Cancer Center Cool SpringsFranklin, Tennessee  37067
West Virginia University CharlestonCharleston, West Virginia  25304
Marshfield Clinic-Chippewa CenterChippewa Falls, Wisconsin  54729
Medical Consultants LimitedMilwaukee, Wisconsin  53215
Marshfield Clinic Cancer Care at Saint Michael's HospitalStevens Point, Wisconsin  54481
Adams Cancer CenterGettysburg, Pennsylvania  17325
Cherry Tree Cancer CenterHanover, Pennsylvania  17331
Spector, David MD (UIA Investigator)Moline, Illinois  61265
Doctors Carrol, Sheth, RaghavanLouisville, Kentucky  40215
Gundersen LutheranLa Crosse, Wisconsin  54601
New York Oncology Hematology PC -Albany Medical CenterAlbany, New York  12208
New York Oncology Hematology PC - AlbanyAlbany, New York  12206
New York Oncology Hematology PC - AmsterdamAmsterdam, New York  12010
New York Oncology Hematology PC-HudsonHudson, New York  12534
New York Oncology Hematology PC - LathamLatham, New York  12110
New York Oncology Hematology PC - RexfordRexford, New York  12148
New York Oncology Hematology PC - TroyTroy, New York  12180
Boca Raton Regional HospitalBoca Raton, Florida  33486
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
Essentia Health Duluth Clinic CCOPDuluth, Minnesota  55805
Toledo Clinic Cancer Centers-OregonOregon, Ohio  43616
Geisinger Medical Center-Cancer Center HazeltonHazleton, Pennsylvania  18201
Illinois Cancer Specialists-NilesNiles, Illinois  60714
Springfield Regional Medical CenterSpringfield, Ohio  45505
Lake Region Healthcare Corporation-Cancer CareFergus Falls, Minnesota  56537
Guthrie Clinic-Robert Packer HospitalSayre, Pennsylvania  18840
Blue Ridge Medical Specialists PCBristol, Tennessee  37620