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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

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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 University Baltimore, Maryland  21205
Mayo Clinic Rochester, Minnesota  55905
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Hurley Medical Center Flint, Michigan  48503
Boulder Community Hospital Boulder, Colorado  80301-9019
Porter Adventist Hospital Denver, Colorado  80210
Rose Medical Center Denver, Colorado  80220
Swedish Medical Center Englewood, Colorado  80110
Sky Ridge Medical Center Lone Tree, Colorado  80124
North Suburban Medical Center Thornton, Colorado  80229
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Fairview Ridges Hospital Burnsville, Minnesota  55337
Hutchinson Area Health Care Hutchinson, Minnesota  55350
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Ingalls Memorial Hospital Harvey, Illinois  60426
Methodist Medical Center of Illinois Peoria, Illinois  61636
Memorial Hospital of South Bend South Bend, Indiana  46601
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana  70809
Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
Jackson-Madison County General Hospital Jackson, Tennessee  38301
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Via Christi Regional Medical Center Wichita, Kansas  67214
Iowa Methodist Medical Center Des Moines, Iowa  50309
Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001
Cancer Institute of New Jersey at Hamilton Hamilton, New Jersey  08690
MetroHealth Medical Center Cleveland, Ohio  44109
North Colorado Medical Center Greeley, Colorado  80631
McKee Medical Center Loveland, Colorado  80539
Cancer Center of Kansas - Chanute Chanute, Kansas  66720
Cancer Center of Kansas - Dodge City Dodge City, Kansas  67801
Cancer Center of Kansas - Newton Newton, Kansas  67114
Cancer Center of Kansas - Salina Salina, Kansas  67042
Cancer Center of Kansas - Wellington Wellington, Kansas  67152
Associates in Womens Health Wichita, Kansas  67203
Cancer Center of Kansas - Winfield Winfield, Kansas  67156
Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
Elkhart General Hospital Elkhart, Indiana  46515
Beebe Medical Center Lewes, Delaware  19958
Memorial Hospital Carthage, Illinois  62321
Hematology and Oncology Associates Chicago, Illinois  60611
Galesburg Clinic Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Proctor Hospital Peoria, Illinois  61614
Perry Memorial Hospital Princeton, Illinois  61356
Community Cancer Center of Monroe Monroe, Michigan  48162
Creighton University Medical Center Omaha, Nebraska  68131-2197
Lima Memorial Hospital Lima, Ohio  45804
Mercy Medical Center Springfield, Ohio  45504
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Fulton County Health Center Wauseon, Ohio  43567
Bryn Mawr Hospital Bryn Mawr, Pennsylvania  19010
Exempla Lutheran Medical Center Wheat Ridge, Colorado  80033
Eureka Hospital Eureka, Illinois  61530
Mercy Hospital Coon Rapids, Minnesota  55433
Graham Hospital Association Canton, Illinois  61520
Hematology Oncology Associates of Illinois-Highland Park Highland Park, Illinois  60035
Saint Joseph Medical Center Joliet, Illinois  60435
Trinity Medical Center Moline, Illinois  61265-1291
Medical Oncology and Hematology Associates Des Moines, Iowa  50309
Bixby Medical Center Adrian, Michigan  49221
Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Fairview-Southdale Hospital Edina, Minnesota  55435
Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Regions Hospital Saint Paul, Minnesota  55101
Saint Francis Regional Medical Center Shakopee, Minnesota  55379
Rice Memorial Hospital Willmar, Minnesota  56201
Saint Luke's Hospital Maumee, Ohio  43537
Geisinger Medical Group State College, Pennsylvania  16801
Swedish American Hospital Rockford, Illinois  61104
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Lawrence Memorial Hospital Lawrence, Kansas  66044
Fisher-Titus Medical Center Norwalk, Ohio  44857
UW Cancer Center Johnson Creek Johnson Creek, Wisconsin  53038
Longmont United Hospital Longmont, Colorado  80501
Union Hospital of Cecil County Elkton MD, Maryland  21921
Mayo Clinic in Arizona Scottsdale, Arizona  85259-5404
Mayo Clinic in Florida Jacksonville, Florida  32224
Memorial Medical Center Springfield, Illinois  62781
University of Pittsburgh Pittsburgh, Pennsylvania  15261
Northwestern University Chicago, Illinois  60611
Hennepin County Medical Center Minneapolis, Minnesota  
Saint Alphonsus Regional Medical Center Boise, Idaho  83706
Emory University Atlanta, Georgia  30322
Cancer Center of Kansas - McPherson McPherson, Kansas  67460
Indiana University Medical Center Indianapolis, Indiana  46202
Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado  80218
Wichita CCOP Wichita, Kansas  67214-3882
Alegent Health Immanuel Medical Center Omaha, Nebraska  68122
Alegent Health Bergan Mercy Medical Center Omaha, Nebraska  68124
Flower Hospital Sylvania, Ohio  43560-2197
Metro-Minnesota CCOP St. Louis Park, Minnesota  
Lakeview Hospital Stillwater, Minnesota  55082
Thomas Jefferson University Hospital Philadelphia, Pennsylvania  19131
Decatur Memorial Hospital Decatur, Illinois  62526
Louisiana State University Health Science Center New Orleans, Louisiana  70112
Lankenau Hospital Wynnewood, Pennsylvania  19096
Northern Indiana Cancer Research Consortium South Bend, Indiana  
Butler Memorial Hospital Butler, Pennsylvania  16001
Littleton Adventist Hospital Littleton, Colorado  80122
Parker Adventist Hospital Parker, Colorado  80138
New Ulm Medical Center New Ulm, Minnesota  56073
OSF Saint Francis Medical Center Peoria, Illinois  61637
The Medical Center of Aurora Aurora, Colorado  80012
Penrose-Saint Francis Healthcare Colorado Springs, Colorado  80907
Saint Anthony Central Hospital Denver, Colorado  80204
Exempla Saint Joseph Hospital Denver, Colorado  80218
Colorado Cancer Research Program CCOP Denver, Colorado  80224-2522
Saint Mary's Hospital and Regional Medical Center Grand Junction, Colorado  81502
Saint Mary Corwin Medical Center Pueblo, Colorado  81004
Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Saint Joseph's-Candler Health System Savannah, Georgia  31405
Rush - Copley Medical Center Aurora, Illinois  60504
Joliet Oncology-Hematology Associates Limited Joliet, Illinois  60435
Provena Saint Mary's Hospital Kankakee, Illinois  60901
North Shore Hematology Oncology Libertyville, Illinois  60048
Community Cancer Center Foundation Normal, Illinois  61761
Ottawa Regional Hospital and Healthcare Center Ottawa, Illinois  61350
Pekin Cancer Treatment Center Pekin, Illinois  61554
Illinois Oncology Research Association CCOP Peoria, Illinois  61615
Illinois CancerCare-Peoria Peoria, Illinois  61615
Illinois Valley Hospital Peru, Illinois  61354
West Suburban Cancer Center River Forest, Illinois  60305
Hematology Oncology Associates of Illinois - Skokie Skokie, Illinois  60076
Richard L. Roudebush Veterans Affairs Medical Center Indianapolis, Indiana  46202
Wishard Hospital Indianapolis, Indiana  46202
Saint Anthony Memorial Health Center Michigan City, Indiana  46360
McFarland Clinic Ames, Iowa  50010
Cedar Rapids Oncology Association Cedar Rapids, Iowa  52403
Mercy Hospital Cedar Rapids, Iowa  52403
Medical Oncology and Hematology Associates-West Des Moines Clive, Iowa  50325
Iowa Oncology Research Association CCOP Des Moines, Iowa  50309
Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des Moines Des Moines, Iowa  50309
Mercy Medical Center - North Iowa Mason City, Iowa  50401
Mercy Medical Center-Sioux City Sioux City, Iowa  51104
Saint Luke's Regional Medical Center Sioux City, Iowa  51104
Cancer Center of Kansas - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas-Kingman Kingman, Kansas  67068
Cancer Center of Kansas - Parsons Parsons, Kansas  67357
Cancer Center of Kansas - Pratt Pratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas - Main Office Wichita, Kansas  67214
Medical Center of Louisiana New Orleans, Louisiana  70112
Hickman Cancer Center Adrian, Michigan  49221
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor, Michigan  48106
Oakwood Hospital Dearborn, Michigan  48123
Saint John Hospital and Medical Center Detroit, Michigan  48236
Allegiance Health Jackson, Michigan  49201
Sparrow Hospital Lansing, Michigan  48912
Saint Mary Mercy Hospital Livonia, Michigan  48154
Mercy Memorial Hospital Monroe, Michigan  48162
Saint Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Saint Joseph Mercy Port Huron Port Huron, Michigan  48060
Saint Mary's of Michigan Saginaw, Michigan  48601
Lakeland Hospital St. Joseph, Michigan  49085
Saint John Macomb-Oakland Hospital Warren, Michigan  48093
Miller-Dwan Hospital Duluth, Minnesota  55805
Unity Hospital Fridley, Minnesota  55432
Saint John's Hospital - Healtheast Maplewood, Minnesota  55109
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota  55109
North Memorial Medical Health Center Robbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota  55416
Minnesota Oncology and Hematology PA-Woodbury Woodbury, Minnesota  55125
Lincoln Medical Education Foundation Cancer Resource Center Lincoln, Nebraska  68510
Missouri Valley Cancer Consortium CCOP Omaha, Nebraska  68106
Cooper Hospital University Medical Center Camden, New Jersey  08103
Veterans Adminstration New Jersey Health Care System East Orange, New Jersey  07018-1095
Hematology Oncology Center Incorporated Elyria, Ohio  44035
Saint Rita's Medical Center Lima, Ohio  45801
Saint Charles Hospital Oregon, Ohio  43616
North Coast Cancer Care Sandusky, Ohio  44870
Toledo Community Hospital Oncology Program CCOP Toledo, Ohio  43617
Mercy Cancer Center at Saint Anne Mercy Hospital Toledo, Ohio  43623
University of Toledo Toledo, Ohio  43614
Saint Vincent Mercy Medical Center Toledo, Ohio  43608
Saint Luke's Hospital Bethlehem, Pennsylvania  18015
Pottstown Memorial Medical Center Pottstown, Pennsylvania  19464
Hematology and Oncology Associates of North East Pennsylvania Scranton, Pennsylvania  18508
Geisinger Wyoming Valley Wilkes-Barre, Pennsylvania  18711
Mainline Health CCOP Wynnewood, Pennsylvania  19096
Fredericksburg Oncology Inc Fredericksburg, Virginia  22401
Wheeling Hospital Wheeling, West Virginia  26003
Langlade Hospital and Cancer Center Antigo, Wisconsin  54409
Saint Vincent Hospital Green Bay, Wisconsin  54301
Dean Hematology and Oncology Clinic Madison, Wisconsin  53717
Bay Area Medical Center Marinette, Wisconsin  54143
Aspirus Regional Cancer Center Wausau, Wisconsin  54401
Cancer Center of Kansas-Liberal Liberal, Kansas  67901
UMDNJ - New Jersey Medical School Newark, New Jersey  07103
North Coast Cancer Care-Clyde Clyde, Ohio  43410
Community Health Partners Regional Medical Center Elyria, Ohio  44035
Holy Family Memorial Hospital Manitowoc, Wisconsin  54221
Riverview Hospital Wisconsin Rapids, Wisconsin  54494
Hinsdale Hematology Oncology Associates Incorporated Hinsdale, Illinois  60521
Gundersen Lutheran La Crosse, Wisconsin  54601
Saint Nicholas Hospital Madison, Wisconsin  53715
Alegent Health Lakeside Hospital Omaha, Nebraska  68130
New York Oncology Hematology PC -Albany Medical Center Albany, New York  12208
Central Indiana Cancer Centers - Indianapolis Indianapolis, Indiana  46227
Stanford University Hospitals and Clinics Stanford, California  94305
Siouxland Hematology Oncology Associates Sioux City, Iowa  51101
Carle Foundation - Carle Cancer Center Urbana, Illinois  61801
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa  52403
Marie Yeager Cancer Center Saint Joseph, Michigan  49085
Summa Akron City Hospital Akron, Ohio  44304
The Toledo Hospital/Toledo Children's Hospital Toledo, Ohio  43606
Genesys Regional Medical Center-West Flint Campus Flint, Michigan  48532
Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota  56401
Essentia Health Duluth Clinic CCOP Duluth, Minnesota  55805
Essentia Health Saint Mary's Medical Center Duluth, Minnesota  55805
Toledo Clinic Cancer Centers-Oregon Oregon, Ohio  43616
Geisinger Medical Center-Cancer Center Hazelton Hazleton, Pennsylvania  18201
Community Howard Regional Health Kokomo, Indiana  46904
Indiana University Health La Porte Hospital La Porte, Indiana  46350
Saint Joseph Regional Medical Center-Mishawaka Mishawaka, Indiana  46545-1470
Essentia Health Cancer Center-South University Clinic Fargo, North Dakota  58103
Christiana Care Health System-Christiana Hospital Newark, Delaware  19718
Illinois Cancer Specialists-Niles Niles, Illinois  60714
Toledo Clinic Cancer Centers-Bowling Green Bowling Green, Ohio  43402
Toledo Clinic Cancer Centers-Maumee Maumee, Ohio  43537-1839
Toledo Clinic Cancer Centers-Toledo Toledo, Ohio  43623
IU Health Ball Memorial Hospital Muncie, Indiana  47303