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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 Center Flint, Michigan  48503
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
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
Genesys Hurley Cancer Institute Flint, Michigan  48503
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
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Avera Cancer Institute Sioux Falls, South Dakota  57105
Marshfield Clinic Marshfield, Wisconsin  54449
Ingalls Memorial Hospital Harvey, Illinois  60426
Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
Waukesha Memorial Hospital Waukesha, Wisconsin  53188
Via Christi Regional Medical Center Wichita, Kansas  67214
Iowa Methodist Medical Center Des Moines, Iowa  50309
Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
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
Adena Regional Medical Center Chillicothe, Ohio  54601
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Avera McKennan Hospital and University Health Center Sioux Falls, South Dakota  57105
Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
Parkland Memorial Hospital Dallas, Texas  75235
Creighton University Medical Center Omaha, Nebraska  68131-2197
Mercy Medical Center Springfield, Ohio  45504
Bryn Mawr Hospital Bryn Mawr, Pennsylvania  19010
Exempla Lutheran Medical Center Wheat Ridge, Colorado  80033
Mercy Hospital Coon Rapids, Minnesota  55433
Medical Oncology and Hematology Associates Des Moines, Iowa  50309
Ottumwa Regional Health Center Ottumwa, Iowa  52501
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
Geisinger Medical Group State College, Pennsylvania  16801
Fox Valley Hematology and Oncology Appleton, Wisconsin  54911
Swedish American Hospital Rockford, Illinois  61104
Eastern Connecticut Hematology and Oncology Associates Norwich, Connecticut  06360
Saint Joseph Hospital Chicago, Illinois  60657
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Lawrence Memorial Hospital Lawrence, Kansas  66044
Mary Rutan Hospital Bellefontaine, Ohio  43311
Knox Community Hospital Mount Vernon, Ohio  43050
Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire, Wisconsin  54701
Marshfield Clinic - Weston Center Weston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin  54494
Longmont United Hospital Longmont, Colorado  80501
University of Pittsburgh Pittsburgh, Pennsylvania  15261
Hennepin County Medical Center Minneapolis, Minnesota  
Saint Alphonsus Regional Medical Center Boise, Idaho  83706
Case Western Reserve University Cleveland, Ohio  44106
Albert Einstein Medical Center Philadelphia, Pennsylvania  19141
Lakeland Regional Cancer Center Lakeland, Florida  33805
Riverside Methodist Hospital Columbus, Ohio  43214
Licking Memorial Hospital Newark, Ohio  43055-2899
Cancer Center of Kansas - McPherson McPherson, Kansas  67460
Columbus CCOP Columbus, Ohio  43206
Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado  80218
University of Texas Southwestern Medical Center Dallas, Texas  
Wichita CCOP Wichita, Kansas  67214-3882
Alegent Health Immanuel Medical Center Omaha, Nebraska  68122
Alegent Health Bergan Mercy Medical Center Omaha, Nebraska  68124
Metro-Minnesota CCOP St. Louis Park, Minnesota  
Tufts Medical Center Boston, Massachusetts  02111
Lakeview Hospital Stillwater, Minnesota  55082
Lankenau Hospital Wynnewood, Pennsylvania  19096
Littleton Adventist Hospital Littleton, Colorado  80122
New Ulm Medical Center New Ulm, Minnesota  56073
Froedtert and the Medical College of Wisconsin Milwaukee, Wisconsin  53226
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
The Hospital of Central Connecticut New Britain, Connecticut  06050
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-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
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
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
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
Missouri Valley Cancer Consortium CCOP Omaha, Nebraska  68106
Hunterdon Medical Center Flemington, New Jersey  08822
Aultman Health Foundation Canton, Ohio  44710
Doctors Hospital Columbus, Ohio  43228
Grant Medical Center Columbus, Ohio  43215
Mount Carmel Health Center West Columbus, Ohio  43222
Saint Rita's Medical Center Lima, Ohio  45801
Marietta Memorial Hospital Marietta, Ohio  45750
Genesis HealthCare System Zanesville, Ohio  43701
Pottstown Memorial Medical Center Pottstown, Pennsylvania  19464
Geisinger Wyoming Valley Wilkes-Barre, Pennsylvania  18711
Mainline Health CCOP Wynnewood, Pennsylvania  19096
Dean Hematology and Oncology Clinic Madison, Wisconsin  53717
Marshfield Clinic-Minocqua Center Minocqua, Wisconsin  54548
Oconomowoc Memorial Hospital-ProHealth Care Inc Oconomowoc, Wisconsin  53066-3896
Marshfield Clinic at James Beck Cancer Center Rhinelander, Wisconsin  54501
Marshfield Clinic-Rice Lake Center Rice Lake, Wisconsin  54868
Marshfield Clinic-Wausau Center Wausau, Wisconsin  54401
Roger Maris Cancer Center Fargo, North Dakota  58122
Cancer Center of Kansas-Liberal Liberal, Kansas  67901
UMDNJ - New Jersey Medical School Newark, New Jersey  07103
Saint Mary Medical and Regional Cancer Center Langhorne, Pennsylvania  19047
West Virginia University Charleston Charleston, West Virginia  25304
Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin  54729
Marshfield Clinic Cancer Care at Saint Michael's Hospital Stevens Point, Wisconsin  54481
Connecticut Oncology and Hematology LLP Torrington, Connecticut  06790
Hinsdale Hematology Oncology Associates Incorporated Hinsdale, Illinois  60521
The Christ Hospital Cincinnati, Ohio  45219
Southern Ohio Medical Center Portsmouth, Ohio  45662
Dallas VA Medical Center Dallas, Texas  75216
Alegent Health Lakeside Hospital Omaha, Nebraska  68130
Siouxland Hematology Oncology Associates Sioux City, Iowa  51101
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa  52403
Sanford Clinic North-Fargo Fargo, North Dakota  58102
Sanford Medical Center-Fargo Fargo, North Dakota  58122
Summa Akron City Hospital Akron, Ohio  44304
Genesys Regional Medical Center-West Flint Campus Flint, Michigan  48532
Sanford Clinic North-Bemidgi Bemidji, Minnesota  56601
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
Geisinger Medical Center-Cancer Center Hazelton Hazleton, Pennsylvania  18201
Springfield Regional Medical Center Springfield, Ohio  45505
PinnacleHealth Fox Chase Regional Cancer Center at Polyclinic Hospital Harrisburg, Pennsylvania  17110