Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 1 of 1 for:    ECOG E3508
Previous Study | Return to List | Next Study

Paclitaxel, Carboplatin, and Bevacizumab With or Without Cixutumumab in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer

This study has been terminated.
(The study was closed to accrual due to the end of the clinical development program with cixutumumab.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00955305
First received: August 7, 2009
Last updated: September 12, 2016
Last verified: September 2016
  Purpose
This randomized phase II trial studies how well carboplatin, paclitaxel, and bevacizumab (CPB) work when given with or without cixutumumab in treating patients with non-small cell lung cancer that is stage IV or has come back (recurrent). Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Other types of monoclonal antibodies, such as cixutumumab, may find tumor cells and help kill them. It is not yet known whether giving more than one drug (combination chemotherapy) together with bevacizumab is more effective when given with or without cixutumumab in treating patients with non-small cell lung cancer.

Condition Intervention Phase
Large Cell Lung Carcinoma
Lung Adenocarcinoma
Recurrent Non-Small Cell Lung Carcinoma
Stage IV Non-Small Cell Lung Cancer
Bronchioloalveolar Lung Carcinoma
Biological: Bevacizumab
Drug: Carboplatin
Biological: Cixutumumab
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; up to 5 years ]

    Progression-free survival was defined as the time from randomization to progression or death without documentation of progression. For cases without progression, follow-up was censored at the date of last disease assessment without progression, unless death occurs within 3 months following the date last known progression-free, in which case the death was counted as a failure.

    Progression was evaluated using RECIST 1.1 criteria and defined as:

    1. At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.

      OR

    2. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; up to 5 years ]
    Overall survival is defined as the time from randomization to death or date last known alive.

  • Proportion of Patients With Objective Response [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry; up to 5 years ]

    Objective response was evaluated using the RECIST 1.1 criteria.

    Objective response includes complete response (CR) and partial response (PR). Objective response is defined as disappearance of all target lesions or at least a 30% decrease in the sum of the diameters of target lesions. In addition, non-target lesions do not meet the criteria for disease progression and no new lesions were observed.



Enrollment: 175
Study Start Date: March 2010
Estimated Study Completion Date: June 2018
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A (CPB)
Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
Biological: Bevacizumab
Given IV
Other Names:
  • NSC 704865
  • Avastin
  • rhuMAb-VEGF
Drug: Carboplatin
Given IV
Other Names:
  • CBDCA
  • Paraplatin
  • JM-8
  • NSC 241240
Drug: Paclitaxel
Given IV
Other Name: Taxol
Experimental: Arm B (CPB+cixutumumab)
Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. 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.
Biological: Bevacizumab
Given IV
Other Names:
  • NSC 704865
  • Avastin
  • rhuMAb-VEGF
Drug: Carboplatin
Given IV
Other Names:
  • CBDCA
  • Paraplatin
  • JM-8
  • NSC 241240
Biological: Cixutumumab
Given IV
Other Names:
  • NSC 742460
  • IMC-A12
Drug: Paclitaxel
Given IV
Other Name: Taxol

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the progression-free survival with the combination of carboplatin, paclitaxel, and bevacizumab, and +/- IMC-A12 (cixutumumab) in patients with advanced, 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 randomized to 1 of 2 treatment arms.

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

ARM B (CPB+cixutumumab): Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed with non-squamous, non-small cell lung cancer (NSCLC)
  • Advanced NSCLC defined as either recurrent disease after prior radiation or surgery or stage IV (M1a or M1b) based on the TNM staging system (American Joint Committee on Cancer [AJCC] 2009)
  • Measurable disease as defined by the revised Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). All sites of disease (of target and non-target disease sites) must be obtained within 4 weeks prior to randomization
  • A head computed tomography (CT) or magnetic resonance imaging (MRI) required within 4 weeks prior to randomization
  • Prior radiation therapy (RT) is allowed if it has been completed 3 weeks prior to randomization and patient has recovered from any adverse events related to RT
  • 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 progression in the brain; at least 6 weeks should have elapsed from the time of craniotomy and at least 4 weeks from radiotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Absolute neutrophil count (ANC) ≥ 1500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin within institutional upper limit of normal (ULN)
  • Serum creatinine ≤ 1.5 x ULN
  • Fasting blood glucose within normal range (fasting < 120 mg/dL or below ULN)
  • Alkaline phosphatase (ALP) ≤ 3 x ULN
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN
  • Urine dipstick must be ≤ 0-1+ within 2 weeks (14 days) of randomization; if urine dipstick result is > 1+, a calculation of urine protein creatinine (UPC) ratio is required; patients must have a UPC ratio < 1.0 to participate in the study
  • Neuropathy, if present at baseline, must be ≤ Common Terminology Criteria for Adverse Events (CTCAE) grade 1
  • Patients with a history of hypertension must be well-controlled (≤ 150/90) on a stable regimen of anti-hypertensive therapy
  • Women of childbearing potential and sexually active males should use an accepted and effective method of contraception while on treatment and for 3 months thereafter

Exclusion Criteria:

  • Prior chemotherapy or biologic/molecular targeted therapy for advanced NSCLC. Prior chemotherapy and/or biological/molecular targeted therapy as part of initial potentially curative therapy (one regimen of induction and/or adjuvant and/or concurrent chemoradiotherapy) was allowed provided it had been completed 1 year or more prior to randomization
  • Prior treatment with IMC-A12 or another insulin-like growth factor 1 receptor (IGF-1R) inhibitor
  • Patients on therapeutic anticoagulation; patient's international normalized ratio (INR) must be ≤ 1.5 or partial thromboplastin time (PTT) ≤ upper limits of normal within 2 weeks prior to randomization to be eligible; prophylactic anticoagulation of venous access devices is allowed provided the above criteria have been met
  • Prior allergic reaction to compounds of chemical or biologic composition similar to those of IMC-A12
  • Hypersensitivity to any component of bevacizumab
  • Poorly controlled diabetes mellitus
  • History of other invasive malignancies unless there is no active disease and all treatment has been completed ≥ 3 years prior to randomization; patients with history of in-situ malignancies and curatively resected nonmelanomatous skin cancer are eligible
  • History of thrombotic or hemorrhagic disorders
  • History of bleeding diathesis or coagulopathy
  • ≥ grade 2 bleeding or any bleeding requiring intervention within 4 weeks prior to randomization
  • History of gross hemoptysis (defined as ≥ 1/2 teaspoon of bright red blood)
  • Any of the following within 6 months prior to randomization:

    • Abdominal fistula
    • Gastrointestinal perforation
    • Intra-abdominal abscess
    • Previous myocardial infarction
    • History of any central nervous system (CNS) cerebrovascular ischemia
    • New York Heart Association (NYHA) > class II congestive heart failure or severe heart failure
    • Unstable or symptomatic angina pectoris
    • History of stroke
    • Significant vascular disease
    • Symptomatic peripheral vascular disease
  • Ongoing, serious cardiac arrhythmia requiring medication at time of randomization
  • Ongoing, active infection or ongoing fever at the time of randomization or any co-existing medical condition, psychiatric illness or limitations that would interfere with compliance of study requirements
  • History of hypertensive crisis or hypertensive encephalopathy
  • Any of the following within 4 weeks prior to randomization: a serious non-healing wound, ulcer, bone fracture, or major surgical procedure
  • Anticipated major surgical procedure(s) during the course of the study
  • Receiving daily treatment with aspirin (> 325 mg/day) or non-steroidal anti-inflammatory agents (NSAIDs) known to inhibit platelet function for chronic conditions; patients must not be receiving treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix), and/or cilostazol (Pletal); if patient was receiving any of the following: aspirin (> 325 mg/day), NSAID, and/or anti-platelet drugs, patient must have discontinued its use ≥ 1 week prior to randomization
  • Pregnant or breast-feeding
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955305

  Hide Study Locations
Locations
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
SCL Health Saint Joseph Hospital
Denver, Colorado, United States, 80218
Rose Medical Center
Denver, Colorado, United States, 80220
Colorado Cancer Research Program NCORP
Denver, Colorado, United States, 80222
Swedish Medical Center
Englewood, Colorado, United States, 80113
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Saint Anthony Hospital
Lakewood, Colorado, United States, 80228
Littleton Adventist Hospital
Littleton, Colorado, United States, 80122
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States, 06105
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
Charlotte Hungerford Hospital Center for Cancer Care
Torrington, Connecticut, United States, 06790
United States, Florida
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
United States, Georgia
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
United States, Illinois
Saint Joseph Hospital
Chicago, Illinois, United States, 60657
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Hinsdale Hematology Oncology Associates Incorporated
Hinsdale, Illinois, United States, 60521
Swedish American Hospital
Rockford, Illinois, United States, 61104
SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois, United States, 61114
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Mercy Hospital
Cedar Rapids, Iowa, United States, 52403
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Mercy Cancer Center-West Lakes
Clive, Iowa, United States, 50325
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Ottumwa Regional Health Center
Ottumwa, Iowa, United States, 52501
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States, 67460
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wichita NCI Community Oncology Research Program
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium CCOP
Ann Arbor, Michigan, United States, 48106
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Hurley Medical Center
Flint, Michigan, United States, 48502
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Allegiance Health
Jackson, Michigan, United States, 49201
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States, 56601
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Nebraska
Alegent Health Lakeside Hospital
Omaha, Nebraska, United States, 68130
United States, New Jersey
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, United States, 07018-1095
Hunterdon Medical Center
Flemington, New Jersey, United States, 08822
Rutgers New Jersey Medical School
Newark, New Jersey, United States, 07101
United States, North Dakota
Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Sanford Clinic North-Fargo
Fargo, North Dakota, United States, 58122
Sanford Medical Center-Fargo
Fargo, North Dakota, United States, 58122
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Mary Rutan Hospital
Bellefontaine, Ohio, United States, 43311
Mercy Medical Center
Canton, Ohio, United States, 44708
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Columbus NCI Community Oncology Research Program
Columbus, Ohio, United States, 43215
Grant Medical Center
Columbus, Ohio, United States, 43215
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Doctors Hospital
Columbus, Ohio, United States, 43228
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Saint Rita's Medical Center
Lima, Ohio, United States, 45801
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Southern Ohio Medical Center
Portsmouth, Ohio, United States, 45662
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States, 43701
United States, Pennsylvania
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
PinnacleHealth Cancer Center-Community Campus
Harrisburg, Pennsylvania, United States, 17109
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States, 18201
Saint Mary Medical and Regional Cancer Center
Langhorne, Pennsylvania, United States, 19047
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Pottstown Memorial Medical Center
Pottstown, Pennsylvania, United States, 19464
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Reading Hospital
West Reading, Pennsylvania, United States, 19611
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
Main Line Health NCORP
Wynnewood, Pennsylvania, United States, 19096
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States, 57105
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
United States, West Virginia
West Virginia University Charleston
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Fox Valley Hematology and Oncology
Appleton, Wisconsin, United States, 54913
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States, 54701
Dean Hematology and Oncology Clinic
Madison, Wisconsin, United States, 53717
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States, 54017
Oconomowoc Memorial Hospital-ProHealth Care Inc
Oconomowoc, Wisconsin, United States, 53066
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States, 53188
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Athanassios (Ethan) Argiris ECOG-ACRIN Cancer Research Group
  More Information

Publications:
Argiris, A., Lee, J., Leach, J.W., Schiller, J.H.: Safety analysis of a phase II randomized trial of carboplatin (C), Paclitaxel (P), bevacizumab (B) with or without cixutumumab (CX) in patients (pts) with advanced non-squamous, non-small cell lung cancer (NSCLC). J Clin Oncol 2014;31(15s). Abstract e19018.

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00955305     History of Changes
Other Study ID Numbers: NCI-2011-01960
NCI-2011-01960 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
E3508 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
U10CA180820 ( US NIH Grant/Contract Award Number )
U10CA021115 ( US NIH Grant/Contract Award Number )
Study First Received: August 7, 2009
Results First Received: July 26, 2016
Last Updated: September 12, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.

Keywords provided by National Cancer Institute (NCI):
Non-Small Cell Lung Cancer
cixutumumab

Additional relevant MeSH terms:
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Adenocarcinoma, Bronchiolo-Alveolar
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Bevacizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on April 28, 2017