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A Phase II Randomized Trial of Paclitaxel, Carboplatin, Bevacizumab With or Without IMC-A12 in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Adenocarcinoma of the Lung, Bronchoalveolar Cell Lung Cancer, Large Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

Thank you

Trial Information

A Phase II Randomized Trial of Paclitaxel, Carboplatin, Bevacizumab With or Without IMC-A12 in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer


PRIMARY OBJECTIVES:

I. To evaluate the progression-free survival with the combination of carboplatin,
paclitaxel, and bevacizumab with vs without cixutumumab in patients with stage IV or
recurrent non-squamous, non-small cell lung cancer.

SECONDARY OBJECTIVES:

I. To evaluate overall survival and response rate of the above combination in patients with
non-squamous, advanced non-small cell lung cancer.

II. To evaluate the toxicities of the above combination in patients with non-squamous
advanced non-small cell lung cancer.

OUTLINE: Patients are stratified according to ECOG performance status (0 vs 1). Patients are
randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours, carboplatin IV over 30
minutes, and bevacizumab IV over 30-90 minutes on day 1.

ARM II: Patients receive paclitaxel, carboplatin, and bevacizumab as in arm I. Patients also
receive cixutumumab IV over 1 hour on days 1, 8, and 15.In both arms, treatment repeats
every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment with bevacizumab and cixutumumab may continue 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 3 years.


Inclusion Criteria:



- Histologically or cytologically confirmed non-squamous, non-small celllung cancer
(NSCLC), including any of the following subtypes*:

- Adenocarcinoma

- Large cell

- Bronchioloalveolar

- NSCLC not otherwise specified

- Advanced disease, as defined by any of the following:

- Stage IV (M1a or M1b)* disease based on the TNM staging system

- Recurrent disease after prior radiotherapy or surgery

- Measurable disease, as defined by RECIST (PET and the PET portion of PET/CT are not
acceptable methods of evaluation for response)

- No prior radiotherapy to the only area of measurable disease unless there is
progression of disease documented by physical examination, imaging tests, or
pathology in this region

- Brain metastases are allowed, provided they have been treated with surgery and/or
radiotherapy, the patient is neurologically stable, and repeat brain imaging shows no
tumor progression in the brain

- Patients must undergo head CT scan or MRI within 4 weeks prior to randomization
for evaluation

- At least 6 weeks since prior craniotomy and ≥ 4 weeks since prior radiotherapy

- ECOG performance status 0-1

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Total bilirubin normal

- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)

- Fasting blood glucose normal (fasting < 120 mg/dL or below ULN)

- AST and ALT ≤ 3 times ULN

- Alkaline phosphatase ≤ 3 times ULN

- Urine protein by dipstick ≤ 1+ (within 2 weeks of randomization) OR urine
protein:creatinine < 1.0

- INR < 1.5 or PTT normal

- Neuropathy ≤ CTCAE grade 1

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after
completion of study treatment

- No prior allergic reaction to compounds of chemical or biological composition similar
to those of cixutumumab

- No known hypersensitivity to any component of bevacizumab

- No poorly controlled diabetes mellitus

- History of diabetes mellitus allowed, provided blood glucose is within normal
range

- No history of other invasive malignancies unless there is no active disease and all
treatment has been completed > 3 years prior to study

- Patients with history of in-situ malignancies and curatively resected
nonmelanomatous skin cancer are allowed

- Patients with a history of breast cancer (without evidence of disease for ≥ 3
years) who recently completed adjuvant hormonal therapy < 3 years from the date
of registration are eligible

- No history of thrombotic or hemorrhagic disorders

- No history of bleeding diathesis or coagulopathy

- No bleeding ≥ grade 2 (CTCAE version 3) requiring intervention within the past 4weeks

- No history of gross hemoptysis (defined as > ½ teaspoon of bright red blood)

- No history of hypertensive crisis or hypertensive encephalopathy

- History of hypertension allowed provided it is well-controlled (< 150/90 mm Hg) by
stable anti-hypertensive therapy

- None of the following conditions within the past 6 months:

- Abdominal fistula

- Gastrointestinal perforation

- Intra-abdominal abscess

- Myocardial infarction

- Stroke

- Any CNS cerebrovascular ischemia

- New York Heart Association class II-IV congestive heart failure or severe heart
failure

- Unstable or symptomatic angina pectoris

- Significant vascular disease

- Symptomatic peripheral vascular disease

- No ongoing, serious cardiac arrhythmia requiring medication

- No ongoing, active infection or fever

- No co-existing medical condition, psychiatric illness or limitations that would
interfere with compliance of study requirements

- No serious non-healing wound, ulcer, bone fracture within the past 4 weeks

- No other concurrent anticancer therapy (e.g., biologic agents, chemotherapy, or
radiotherapy)

- No prior chemotherapy or biologic or molecular targeted therapy for advanced NSCLC

- No prior cixutumumab or another IGF-IR inhibitor

- At least 3 weeks since prior radiotherapy and recovered

- More than 1 year since prior chemotherapy and/or biological or molecular targeted
therapy as part of initial potentially curative therapy (i.e., one regimen of
induction and/or adjuvant and/or concurrent chemoradiotherapy)

- More than 4 weeks since prior and no concurrent major surgical procedure

- More than 7 days since prior minor surgical procedure

- More than 1 week since prior and no concurrent daily treatment with acetylsalicylic
acid (> 325 mg/day) or other non-steroidalanti-inflammatory agents

- More than 1 week since prior and no concurrent dipyridamole (Persantine), ticlopidine
(Ticlid),clopidogrel (Plavix), and/or cilostazol (Pletal)

- No concurrent therapeutic anticoagulation, except prophylactic anticoagulation of
venous access device

- No concurrent combination antiretroviral therapy in HIV-positive patients

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 assessed by Response Evaluation Criteria for Solid Tumors (RECIST)

Outcome Time Frame:

From randomization to disease progression or death from any cause, up to 5 years

Safety Issue:

No

Principal Investigator

Athanassios Argiris

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-01960

NCT ID:

NCT00955305

Start Date:

March 2010

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Lung
  • Bronchoalveolar Cell Lung Cancer
  • Large Cell Lung Cancer
  • Recurrent Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Adenocarcinoma, Bronchiolo-Alveolar
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Hurley Medical CenterFlint, Michigan  48503
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
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
Genesys Hurley Cancer InstituteFlint, Michigan  48503
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
Ingalls Memorial HospitalHarvey, Illinois  60426
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Waukesha Memorial HospitalWaukesha, Wisconsin  53188
Via Christi Regional Medical CenterWichita, Kansas  67214
Iowa Methodist Medical CenterDes Moines, Iowa  50309
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
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
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Parkland Memorial HospitalDallas, Texas  75235
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Mercy Medical CenterSpringfield, Ohio  45504
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Mercy HospitalCoon Rapids, Minnesota  55433
Medical Oncology and Hematology AssociatesDes Moines, Iowa  50309
Ottumwa Regional Health CenterOttumwa, Iowa  52501
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
Geisinger Medical GroupState College, Pennsylvania  16801
Fox Valley Hematology and OncologyAppleton, Wisconsin  54911
Swedish American HospitalRockford, Illinois  61104
Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut  06360
Saint Joseph HospitalChicago, Illinois  60657
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
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
University of PittsburghPittsburgh, Pennsylvania  15261
Hennepin County Medical CenterMinneapolis, Minnesota  
Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Case Western Reserve UniversityCleveland, Ohio  44106
Albert Einstein Medical CenterPhiladelphia, Pennsylvania  19141
Lakeland Regional Cancer CenterLakeland, Florida  33805
Riverside Methodist HospitalColumbus, Ohio  43214
Licking Memorial HospitalNewark, Ohio  43055-2899
Cancer Center of Kansas - McPhersonMcPherson, Kansas  67460
Columbus CCOPColumbus, Ohio  43206
Presbyterian - Saint Lukes Medical Center - Health OneDenver, Colorado  80218
University of Texas Southwestern Medical CenterDallas, Texas  
Wichita CCOPWichita, Kansas  67214-3882
Alegent Health Immanuel Medical CenterOmaha, Nebraska  68122
Alegent Health Bergan Mercy Medical CenterOmaha, Nebraska  68124
Metro-Minnesota CCOPSt. Louis Park, Minnesota  
Tufts Medical CenterBoston, Massachusetts  02111
Lakeview HospitalStillwater, Minnesota  55082
Lankenau HospitalWynnewood, Pennsylvania  19096
Littleton Adventist HospitalLittleton, Colorado  80122
New Ulm Medical CenterNew Ulm, Minnesota  56073
Froedtert and the Medical College of WisconsinMilwaukee, Wisconsin  53226
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
McFarland ClinicAmes, Iowa  50010
Cedar Rapids Oncology AssociationCedar Rapids, Iowa  52403
Mercy HospitalCedar Rapids, Iowa  52403
Medical Oncology and Hematology Associates-West Des MoinesClive, Iowa  50325
Iowa Oncology Research Association CCOPDes Moines, Iowa  50309
Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des MoinesDes Moines, Iowa  50309
Mercy Medical Center-Sioux CitySioux City, Iowa  51104
Saint Luke's Regional Medical CenterSioux City, Iowa  51104
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
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
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
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
Missouri Valley Cancer Consortium CCOPOmaha, Nebraska  68106
Hunterdon Medical CenterFlemington, New Jersey  08822
Aultman Health FoundationCanton, Ohio  44710
Doctors HospitalColumbus, Ohio  43228
Grant Medical CenterColumbus, Ohio  43215
Mount Carmel Health Center WestColumbus, Ohio  43222
Saint Rita's Medical CenterLima, Ohio  45801
Marietta Memorial HospitalMarietta, Ohio  45750
Genesis HealthCare SystemZanesville, Ohio  43701
Pottstown Memorial Medical CenterPottstown, Pennsylvania  19464
Geisinger Wyoming ValleyWilkes-Barre, Pennsylvania  18711
Mainline Health CCOPWynnewood, Pennsylvania  19096
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
Marshfield Clinic-Wausau CenterWausau, Wisconsin  54401
Roger Maris Cancer CenterFargo, North Dakota  58122
Cancer Center of Kansas-LiberalLiberal, Kansas  67901
UMDNJ - New Jersey Medical SchoolNewark, New Jersey  07103
Saint Mary Medical and Regional Cancer CenterLanghorne, Pennsylvania  19047
West Virginia University CharlestonCharleston, West Virginia  25304
Marshfield Clinic-Chippewa CenterChippewa Falls, Wisconsin  54729
Marshfield Clinic Cancer Care at Saint Michael's HospitalStevens Point, Wisconsin  54481
Connecticut Oncology and Hematology LLPTorrington, Connecticut  06790
Hinsdale Hematology Oncology Associates IncorporatedHinsdale, Illinois  60521
The Christ HospitalCincinnati, Ohio  45219
Southern Ohio Medical CenterPortsmouth, Ohio  45662
Dallas VA Medical CenterDallas, Texas  75216
Alegent Health Lakeside HospitalOmaha, Nebraska  68130
Siouxland Hematology Oncology AssociatesSioux City, Iowa  51101
Oncology Associates at Mercy Medical CenterCedar Rapids, Iowa  52403
Sanford Clinic North-FargoFargo, North Dakota  58102
Sanford Medical Center-FargoFargo, North Dakota  58122
Summa Akron City HospitalAkron, Ohio  44304
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
Sanford Clinic North-BemidgiBemidji, Minnesota  56601
Essentia Health Saint Joseph's Medical CenterBrainerd, Minnesota  56401
Essentia Health Duluth Clinic CCOPDuluth, Minnesota  55805
Essentia Health Saint Mary's Medical CenterDuluth, Minnesota  55805
Geisinger Medical Center-Cancer Center HazeltonHazleton, Pennsylvania  18201
Springfield Regional Medical CenterSpringfield, Ohio  45505
PinnacleHealth Fox Chase Regional Cancer Center at Polyclinic HospitalHarrisburg, Pennsylvania  17110