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Randomized Phase II Study of Paclitaxel With or Without the Anti-IGF-IR mAb Cixutumumab (IMC-A12) as Second Line Treatment for Patients With Metastatic Esophageal or GE Junction Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Adenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Recurrent Esophageal Cancer, Squamous Cell Carcinoma of the Esophagus, Stage IV Esophageal Cancer

Thank you

Trial Information

Randomized Phase II Study of Paclitaxel With or Without the Anti-IGF-IR mAb Cixutumumab (IMC-A12) as Second Line Treatment for Patients With Metastatic Esophageal or GE Junction Cancer


PRIMARY OBJECTIVES:

I. To evaluate the progression-free survival of paclitaxel plus cixutumumab (IMC-A12) versus
paclitaxel alone as second-line therapy in patients with metastatic esophagus or GE junction
cancer.

SECONDARY OBJECTIVES:

I. To evaluate the overall survival of paclitaxel plus cixutumumab (IMC-A12) versus
paclitaxel alone in this patient population.

II. To evaluate the response rate of paclitaxel plus cixutumumab (IMC-A12) versus paclitaxel
alone in this patient population.

III. To evaluate the toxicity of cixutumumab (IMC-A12) plus paclitaxel versus paclitaxel
alone in this patient population.

IV. Exploratory analyses will assess potentially relevant cixutumumab (IMC-A12)
pharmacodynamic biomarkers obtained from serum samples, including but not limited to, IGF-I,
IGF-II, IGFBP-2, and IGFBP-3.

OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis
(gastroesophageal junction vs esophageal cancer) and cell type (squamous cell carcinoma vs
adenocarcinoma). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over I hour on days 1, 8, and 15.

ARM II: Patients receive cixutumumab IV over 1 hour on days 1 and 15, and paclitaxel as in
arm I.

In both arms, courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.

After completion of study therapy, patients are followed up every 3 months for 2 years.


Inclusion Criteria:



- Histologically, cytologically, or radiologically confirmed metastatic esophageal or
gastroesophageal junction meeting 1 of the following criteria:

- Squamous cell carcinoma

- Adenocarcinoma

- Undifferentiated adenocarcinomas and adenosquamous tumors will be
considered as adenocarcinomas

- Patients with adenocarcinoma of the gastroesophageal or esophagogastric (AEG)
junction tumors meeting the following:

- AEG type I: adenocarcinoma of the distal esophagus that usually arises from an
area with specialized intestinal metaplasia of the esophagus (i.e., Barrett
esophagus) and may infiltrate the esophagogastric junction from above

- AEG type II: true carcinoma of the cardia arising from the cardiac epithelium or
short segments with intestinal metaplasia at the esophagogastric junction

- No AEG type III: subcardial gastric carcinoma that infiltrates the
esophagogastric junction and distal esophagus from below

- Evidence of local recurrence or local residual (post-resection) disease by radiology,
endoscopy, histology, or cytology allowed

- Measurable disease

- Must have received and progressed on 1 line of prior systemic therapy for esophageal
or esophagogastric cancer meeting ≥ 1 of the following criteria:

- May have included one regimen for metastatic disease, or one regimen with
radiotherapy for initially locally advanced disease

- If patients progress or recur within 6 months of neoadjuvant/adjuvant therapy,
this will be considered one line of therapy

- For patients progressing or recurring more than 6 months after
neoadjuvant/adjuvant therapy, they will need to receive one line of therapy
for recurrent disease to be eligible

- If patients receive one regimen in which a chemotherapy agent is dropped for
toxicity without progression, this treatment will be considered 1 line of
therapy

- Substitution or addition of a new agent will be considered a second line of
therapy

- ECOG performance status 0-2

- Life expectancy ≥ 12 weeks

- Leukocytes ≥ 3,000/mm^3

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL

- Total bilirubin normal

- AST and/or ALT ≤ 3 times upper limit of normal (ULN)

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

- Fasting serum glucose ≤ 160 mg/dL and hemoglobin A_1C ≤ 7%

- Fasting glucose not required if non-fasting glucose ≤ 160 mg/dL

- History of diabetes mellitus allowed provided blood glucose is within normal
range and patients are on a stable dietary or therapeutic regimen

- Not pregnant or nursing

- Negative pregnancy test

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

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to cixutumumab

- No psychiatric illness that would prevent the patient from giving informed consent

- None of the following medical conditions that, in the opinion of the treating
physician, would make this protocol unreasonably hazardous for the patient

- Active and/or uncontrolled infection, including HIV positivity

- Cardiac disease including, but not limited to, any of the following:

- Uncontrolled high-blood pressure

- Unstable angina

- Serious uncontrolled cardiac arrhythmia

- No currently active second malignancy except nonmelanoma skin cancer or curatively
treated malignancy with < 30% risk of relapse

- No prior treatment with other agents targeting the IGFR

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

- No prior taxane or anti-IGFR therapy

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 of paclitaxel plus cixutumumab versus paclitaxel alone as second-line therapy in patients with metastatic esophagus or GE junction cancer

Outcome Time Frame:

Up to 27 months

Safety Issue:

No

Principal Investigator

Steven Cohen

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-02045

NCT ID:

NCT01142388

Start Date:

September 2010

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Esophagus
  • Adenocarcinoma of the Gastroesophageal Junction
  • Recurrent Esophageal Cancer
  • Squamous Cell Carcinoma of the Esophagus
  • Stage IV Esophageal Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
Mayo ClinicRochester, Minnesota  55905
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
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
Ingalls Memorial HospitalHarvey, Illinois  60426
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Jackson-Madison County General HospitalJackson, Tennessee  38301
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Via Christi Regional Medical CenterWichita, Kansas  67214
Iowa Methodist Medical CenterDes Moines, Iowa  50309
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001
Cancer Institute of New Jersey at HamiltonHamilton, New Jersey  08690
MetroHealth Medical CenterCleveland, Ohio  44109
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
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Elkhart General HospitalElkhart, Indiana  46515
Beebe Medical CenterLewes, Delaware  19958
Memorial HospitalCarthage, Illinois  62321
Hematology and Oncology AssociatesChicago, Illinois  60611
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
Lima Memorial HospitalLima, Ohio  45804
Mercy Medical CenterSpringfield, Ohio  45504
Mercy Hospital of TiffinTiffin, Ohio  44883
Fulton County Health CenterWauseon, Ohio  43567
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Eureka HospitalEureka, Illinois  61530
Mercy HospitalCoon Rapids, Minnesota  55433
Graham Hospital AssociationCanton, Illinois  61520
Hematology Oncology Associates of Illinois-Highland ParkHighland Park, Illinois  60035
Saint Joseph Medical CenterJoliet, Illinois  60435
Trinity Medical CenterMoline, Illinois  61265-1291
Medical Oncology and Hematology AssociatesDes Moines, Iowa  50309
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
Geisinger Medical GroupState College, Pennsylvania  16801
Swedish American HospitalRockford, Illinois  61104
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Lawrence Memorial HospitalLawrence, Kansas  66044
Fisher-Titus Medical CenterNorwalk, Ohio  44857
UW Cancer Center Johnson CreekJohnson Creek, Wisconsin  53038
Longmont United HospitalLongmont, Colorado  80501
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404
Mayo Clinic in FloridaJacksonville, Florida  32224
Memorial Medical CenterSpringfield, Illinois  62781
University of PittsburghPittsburgh, Pennsylvania  15261
Northwestern UniversityChicago, Illinois  60611
Hennepin County Medical CenterMinneapolis, Minnesota  
Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Emory UniversityAtlanta, Georgia  30322
Cancer Center of Kansas - McPhersonMcPherson, Kansas  67460
Indiana University Medical CenterIndianapolis, Indiana  46202
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
Louisiana State University Health Science CenterNew Orleans, Louisiana  70112
Lankenau HospitalWynnewood, Pennsylvania  19096
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Butler Memorial HospitalButler, Pennsylvania  16001
Littleton Adventist HospitalLittleton, Colorado  80122
Parker Adventist HospitalParker, Colorado  80138
New Ulm Medical CenterNew Ulm, Minnesota  56073
OSF Saint Francis Medical CenterPeoria, Illinois  61637
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
Saint Joseph's-Candler Health SystemSavannah, Georgia  31405
Rush - Copley Medical CenterAurora, Illinois  60504
Joliet Oncology-Hematology Associates LimitedJoliet, Illinois  60435
Provena Saint Mary's HospitalKankakee, Illinois  60901
North Shore Hematology OncologyLibertyville, Illinois  60048
Community Cancer Center FoundationNormal, Illinois  61761
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
West Suburban Cancer CenterRiver Forest, Illinois  60305
Hematology Oncology Associates of Illinois - SkokieSkokie, Illinois  60076
Richard L. Roudebush Veterans Affairs Medical CenterIndianapolis, Indiana  46202
Wishard HospitalIndianapolis, Indiana  46202
Saint Anthony Memorial Health CenterMichigan City, Indiana  46360
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 - North IowaMason City, Iowa  50401
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
Medical Center of LouisianaNew Orleans, Louisiana  70112
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
Lakeland HospitalSt. Joseph, Michigan  49085
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
Lincoln Medical Education Foundation Cancer Resource CenterLincoln, Nebraska  68510
Missouri Valley Cancer Consortium CCOPOmaha, Nebraska  68106
Cooper Hospital University Medical CenterCamden, New Jersey  08103
Veterans Adminstration New Jersey Health Care SystemEast Orange, New Jersey  07018-1095
Hematology Oncology Center IncorporatedElyria, Ohio  44035
Saint Rita's Medical CenterLima, Ohio  45801
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
Saint Vincent Mercy Medical CenterToledo, Ohio  43608
Saint Luke's HospitalBethlehem, Pennsylvania  18015
Pottstown Memorial Medical CenterPottstown, Pennsylvania  19464
Hematology and Oncology Associates of North East PennsylvaniaScranton, Pennsylvania  18508
Geisinger Wyoming ValleyWilkes-Barre, Pennsylvania  18711
Mainline Health CCOPWynnewood, Pennsylvania  19096
Fredericksburg Oncology IncFredericksburg, Virginia  22401
Wheeling HospitalWheeling, West Virginia  26003
Langlade Hospital and Cancer CenterAntigo, Wisconsin  54409
Saint Vincent HospitalGreen Bay, Wisconsin  54301
Dean Hematology and Oncology ClinicMadison, Wisconsin  53717
Bay Area Medical CenterMarinette, Wisconsin  54143
Aspirus Regional Cancer CenterWausau, Wisconsin  54401
Cancer Center of Kansas-LiberalLiberal, Kansas  67901
UMDNJ - New Jersey Medical SchoolNewark, New Jersey  07103
North Coast Cancer Care-ClydeClyde, Ohio  43410
Community Health Partners Regional Medical CenterElyria, Ohio  44035
Holy Family Memorial HospitalManitowoc, Wisconsin  54221
Riverview HospitalWisconsin Rapids, Wisconsin  54494
Hinsdale Hematology Oncology Associates IncorporatedHinsdale, Illinois  60521
Gundersen LutheranLa Crosse, Wisconsin  54601
Saint Nicholas HospitalMadison, Wisconsin  53715
Alegent Health Lakeside HospitalOmaha, Nebraska  68130
New York Oncology Hematology PC -Albany Medical CenterAlbany, New York  12208
Central Indiana Cancer Centers - IndianapolisIndianapolis, Indiana  46227
Stanford University Hospitals and ClinicsStanford, California  94305
Siouxland Hematology Oncology AssociatesSioux City, Iowa  51101
Carle Foundation - Carle Cancer CenterUrbana, Illinois  61801
Oncology Associates at Mercy Medical CenterCedar Rapids, Iowa  52403
Marie Yeager Cancer CenterSaint Joseph, Michigan  49085
Summa Akron City HospitalAkron, Ohio  44304
The Toledo Hospital/Toledo Children's HospitalToledo, Ohio  43606
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
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
Toledo Clinic Cancer Centers-OregonOregon, Ohio  43616
Geisinger Medical Center-Cancer Center HazeltonHazleton, Pennsylvania  18201
Community Howard Regional HealthKokomo, Indiana  46904
Indiana University Health La Porte HospitalLa Porte, Indiana  46350
Saint Joseph Regional Medical Center-MishawakaMishawaka, Indiana  46545-1470
Essentia Health Cancer Center-South University ClinicFargo, North Dakota  58103
Christiana Care Health System-Christiana HospitalNewark, Delaware  19718
Illinois Cancer Specialists-NilesNiles, Illinois  60714
Toledo Clinic Cancer Centers-Bowling GreenBowling Green, Ohio  43402
Toledo Clinic Cancer Centers-MaumeeMaumee, Ohio  43537-1839
Toledo Clinic Cancer Centers-ToledoToledo, Ohio  43623
IU Health Ball Memorial HospitalMuncie, Indiana  47303