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

Primary Purpose

Large Cell Lung Carcinoma, Lung Adenocarcinoma, Recurrent Non-Small Cell Lung Carcinoma

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Bevacizumab

Carboplatin

Cixutumumab

Paclitaxel

About this trial

This is an interventional treatment trial for Large Cell Lung Carcinoma focused on measuring Non-Small Cell Lung Cancer, cixutumumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A (CPB)

Arm B (CPB+cixutumumab)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)

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

Secondary Outcome Measures

Overall Survival (OS)

Overall survival is defined as the time from randomization to death or date last known alive.

Proportion of Patients With Objective Response

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.

Full Information

NCT ID

NCT00955305

First Posted

August 7, 2009

Last Updated

May 3, 2018

Sponsor

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00955305

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Terminated

Why Stopped

The study was closed to accrual due to the end of the clinical development program with cixutumumab.

Study Start Date

March 2010 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Large Cell Lung Carcinoma, Lung Adenocarcinoma, Recurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer, Bronchioloalveolar Lung Carcinoma

Keywords

Non-Small Cell Lung Cancer, cixutumumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

175 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A (CPB)

Arm Type

Active Comparator

Arm Description

Arm Title

Arm B (CPB+cixutumumab)

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

NSC 704865, Avastin, rhuMAb-VEGF

Intervention Description

Given IV

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

CBDCA, Paraplatin, JM-8, NSC 241240

Intervention Description

Given IV

Intervention Type

Biological

Intervention Name(s)

Cixutumumab

Other Intervention Name(s)

NSC 742460, IMC-A12

Intervention Description

Given IV

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

Taxol

Intervention Description

Given IV

Primary Outcome Measure Information:

Title

Progression-free Survival (PFS)

Description

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

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Overall survival is defined as the time from randomization to death or date last known alive.

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

Title

Proportion of Patients With Objective Response

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Athanassios (Ethan) Argiris

Organizational Affiliation

ECOG-ACRIN Cancer Research Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Medical Center of Aurora

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80012

Country

United States

Facility Name

Boulder Community Hospital

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80301

Country

United States

Facility Name

Penrose-Saint Francis Healthcare

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Porter Adventist Hospital

City

Denver

State/Province

Colorado

ZIP/Postal Code

80210

Country

United States

Facility Name

Presbyterian - Saint Lukes Medical Center - Health One

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

SCL Health Saint Joseph Hospital

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

Rose Medical Center

City

Denver

State/Province

Colorado

ZIP/Postal Code

80220

Country

United States

Facility Name

Colorado Cancer Research Program NCORP

City

Denver

State/Province

Colorado

ZIP/Postal Code

80222

Country

United States

Facility Name

Swedish Medical Center

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80113

Country

United States

Facility Name

Saint Mary's Hospital and Regional Medical Center

City

Grand Junction

State/Province

Colorado

ZIP/Postal Code

81502

Country

United States

Facility Name

North Colorado Medical Center

City

Greeley

State/Province

Colorado

ZIP/Postal Code

80631

Country

United States

Facility Name

Saint Anthony Hospital

City

Lakewood

State/Province

Colorado

ZIP/Postal Code

80228

Country

United States

Facility Name

Littleton Adventist Hospital

City

Littleton

State/Province

Colorado

ZIP/Postal Code

80122

Country

United States

Facility Name

Sky Ridge Medical Center

City

Lone Tree

State/Province

Colorado

ZIP/Postal Code

80124

Country

United States

Facility Name

Longmont United Hospital

City

Longmont

State/Province

Colorado

ZIP/Postal Code

80501

Country

United States

Facility Name

McKee Medical Center

City

Loveland

State/Province

Colorado

ZIP/Postal Code

80539

Country

United States

Facility Name

Saint Mary Corwin Medical Center

City

Pueblo

State/Province

Colorado

ZIP/Postal Code

81004

Country

United States

Facility Name

North Suburban Medical Center

City

Thornton

State/Province

Colorado

ZIP/Postal Code

80229

Country

United States

Facility Name

SCL Health Lutheran Medical Center

City

Wheat Ridge

State/Province

Colorado

ZIP/Postal Code

80033

Country

United States

Facility Name

Smilow Cancer Hospital Care Center at Saint Francis

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06105

Country

United States

Facility Name

The Hospital of Central Connecticut

City

New Britain

State/Province

Connecticut

ZIP/Postal Code

06050

Country

United States

Facility Name

Eastern Connecticut Hematology and Oncology Associates

City

Norwich

State/Province

Connecticut

ZIP/Postal Code

06360

Country

United States

Facility Name

Charlotte Hungerford Hospital Center for Cancer Care

City

Torrington

State/Province

Connecticut

ZIP/Postal Code

06790

Country

United States

Facility Name

Lakeland Regional Cancer Center

City

Lakeland

State/Province

Florida

ZIP/Postal Code

33805

Country

United States

Facility Name

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31405

Country

United States

Facility Name

Saint Alphonsus Cancer Care Center-Boise

City

Boise

State/Province

Idaho

ZIP/Postal Code

83706

Country

United States

Facility Name

Saint Joseph Hospital

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60657

Country

United States

Facility Name

Ingalls Memorial Hospital

City

Harvey

State/Province

Illinois

ZIP/Postal Code

60426

Country

United States

Facility Name

Hinsdale Hematology Oncology Associates Incorporated

City

Hinsdale

State/Province

Illinois

ZIP/Postal Code

60521

Country

United States

Facility Name

Swedish American Hospital

City

Rockford

State/Province

Illinois

ZIP/Postal Code

61104

Country

United States

Facility Name

SwedishAmerican Regional Cancer Center/ACT

City

Rockford

State/Province

Illinois

ZIP/Postal Code

61114

Country

United States

Facility Name

McFarland Clinic PC-William R Bliss Cancer Center

City

Ames

State/Province

Iowa

ZIP/Postal Code

50010

Country

United States

Facility Name

Mercy Hospital

City

Cedar Rapids

State/Province

Iowa

ZIP/Postal Code

52403

Country

United States

Facility Name

Oncology Associates at Mercy Medical Center

City

Cedar Rapids

State/Province

Iowa

ZIP/Postal Code

52403

Country

United States

Facility Name

Medical Oncology and Hematology Associates-West Des Moines

City

Clive

State/Province

Iowa

ZIP/Postal Code

50325

Country

United States

Facility Name

Mercy Cancer Center-West Lakes

City

Clive

State/Province

Iowa

ZIP/Postal Code

50325

Country

United States

Facility Name

Iowa Methodist Medical Center

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50309

Country

United States

Facility Name

Iowa-Wide Oncology Research Coalition NCORP

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50309

Country

United States

Facility Name

Medical Oncology and Hematology Associates-Des Moines

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50309

Country

United States

Facility Name

Medical Oncology and Hematology Associates-Laurel

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50314

Country

United States

Facility Name

Mercy Medical Center - Des Moines

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50314

Country

United States

Facility Name

Iowa Lutheran Hospital

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50316

Country

United States

Facility Name

Ottumwa Regional Health Center

City

Ottumwa

State/Province

Iowa

ZIP/Postal Code

52501

Country

United States

Facility Name

Siouxland Regional Cancer Center

City

Sioux City

State/Province

Iowa

ZIP/Postal Code

51101

Country

United States

Facility Name

Mercy Medical Center-Sioux City

City

Sioux City

State/Province

Iowa

ZIP/Postal Code

51104

Country

United States

Facility Name

Saint Luke's Regional Medical Center

City

Sioux City

State/Province

Iowa

ZIP/Postal Code

51104

Country

United States

Facility Name

Cancer Center of Kansas - Chanute

City

Chanute

State/Province

Kansas

ZIP/Postal Code

66720

Country

United States

Facility Name

Cancer Center of Kansas - Dodge City

City

Dodge City

State/Province

Kansas

ZIP/Postal Code

67801

Country

United States

Facility Name

Cancer Center of Kansas - El Dorado

City

El Dorado

State/Province

Kansas

ZIP/Postal Code

67042

Country

United States

Facility Name

Cancer Center of Kansas - Fort Scott

City

Fort Scott

State/Province

Kansas

ZIP/Postal Code

66701

Country

United States

Facility Name

Cancer Center of Kansas-Independence

City

Independence

State/Province

Kansas

ZIP/Postal Code

67301

Country

United States

Facility Name

Cancer Center of Kansas-Kingman

City

Kingman

State/Province

Kansas

ZIP/Postal Code

67068

Country

United States

Facility Name

Lawrence Memorial Hospital

City

Lawrence

State/Province

Kansas

ZIP/Postal Code

66044

Country

United States

Facility Name

Cancer Center of Kansas-Liberal

City

Liberal

State/Province

Kansas

ZIP/Postal Code

67901

Country

United States

Facility Name

Cancer Center of Kansas - McPherson

City

McPherson

State/Province

Kansas

ZIP/Postal Code

67460

Country

United States

Facility Name

Cancer Center of Kansas - Newton

City

Newton

State/Province

Kansas

ZIP/Postal Code

67114

Country

United States

Facility Name

Cancer Center of Kansas - Parsons

City

Parsons

State/Province

Kansas

ZIP/Postal Code

67357

Country

United States

Facility Name

Cancer Center of Kansas - Pratt

City

Pratt

State/Province

Kansas

ZIP/Postal Code

67124

Country

United States

Facility Name

Cancer Center of Kansas - Salina

City

Salina

State/Province

Kansas

ZIP/Postal Code

67401

Country

United States

Facility Name

Cancer Center of Kansas - Wellington

City

Wellington

State/Province

Kansas

ZIP/Postal Code

67152

Country

United States

Facility Name

Associates In Womens Health

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67208

Country

United States

Facility Name

Cancer Center of Kansas-Wichita Medical Arts Tower

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67208

Country

United States

Facility Name

Cancer Center of Kansas - Main Office

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Via Christi Regional Medical Center

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Wichita NCI Community Oncology Research Program

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Cancer Center of Kansas - Winfield

City

Winfield

State/Province

Kansas

ZIP/Postal Code

67156

Country

United States

Facility Name

Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Saint Joseph Mercy Hospital

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48106-0995

Country

United States

Facility Name

Michigan Cancer Research Consortium CCOP

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48106

Country

United States

Facility Name

Oakwood Hospital and Medical Center

City

Dearborn

State/Province

Michigan

ZIP/Postal Code

48124

Country

United States

Facility Name

Saint John Hospital and Medical Center

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48236

Country

United States

Facility Name

Hurley Medical Center

City

Flint

State/Province

Michigan

ZIP/Postal Code

48502

Country

United States

Facility Name

Genesys Hurley Cancer Institute

City

Flint

State/Province

Michigan

ZIP/Postal Code

48503

Country

United States

Facility Name

Genesys Regional Medical Center-West Flint Campus

City

Flint

State/Province

Michigan

ZIP/Postal Code

48532

Country

United States

Facility Name

Allegiance Health

City

Jackson

State/Province

Michigan

ZIP/Postal Code

49201

Country

United States

Facility Name

Borgess Medical Center

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49001

Country

United States

Facility Name

Bronson Methodist Hospital

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49007

Country

United States

Facility Name

West Michigan Cancer Center

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49007

Country

United States

Facility Name

Sparrow Hospital

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48912

Country

United States

Facility Name

Saint Mary Mercy Hospital

City

Livonia

State/Province

Michigan

ZIP/Postal Code

48154

Country

United States

Facility Name

Saint Joseph Mercy Oakland

City

Pontiac

State/Province

Michigan

ZIP/Postal Code

48341

Country

United States

Facility Name

Saint Joseph Mercy Port Huron

City

Port Huron

State/Province

Michigan

ZIP/Postal Code

48060

Country

United States

Facility Name

Saint Mary's of Michigan

City

Saginaw

State/Province

Michigan

ZIP/Postal Code

48601

Country

United States

Facility Name

Saint John Macomb-Oakland Hospital

City

Warren

State/Province

Michigan

ZIP/Postal Code

48093

Country

United States

Facility Name

Sanford Clinic North-Bemidgi

City

Bemidji

State/Province

Minnesota

ZIP/Postal Code

56601

Country

United States

Facility Name

Essentia Health Saint Joseph's Medical Center

City

Brainerd

State/Province

Minnesota

ZIP/Postal Code

56401

Country

United States

Facility Name

Fairview Ridges Hospital

City

Burnsville

State/Province

Minnesota

ZIP/Postal Code

55337

Country

United States

Facility Name

Mercy Hospital

City

Coon Rapids

State/Province

Minnesota

ZIP/Postal Code

55433

Country

United States

Facility Name

Essentia Health Cancer Center

City

Duluth

State/Province

Minnesota

ZIP/Postal Code

55805

Country

United States

Facility Name

Essentia Health Saint Mary's Medical Center

City

Duluth

State/Province

Minnesota

ZIP/Postal Code

55805

Country

United States

Facility Name

Miller-Dwan Hospital

City

Duluth

State/Province

Minnesota

ZIP/Postal Code

55805

Country

United States

Facility Name

Fairview-Southdale Hospital

City

Edina

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

Facility Name

Unity Hospital

City

Fridley

State/Province

Minnesota

ZIP/Postal Code

55432

Country

United States

Facility Name

Hutchinson Area Health Care

City

Hutchinson

State/Province

Minnesota

ZIP/Postal Code

55350

Country

United States

Facility Name

Minnesota Oncology Hematology PA-Maplewood

City

Maplewood

State/Province

Minnesota

ZIP/Postal Code

55109

Country

United States

Facility Name

Saint John's Hospital - Healtheast

City

Maplewood

State/Province

Minnesota

ZIP/Postal Code

55109

Country

United States

Facility Name

Abbott-Northwestern Hospital

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55407

Country

United States

Facility Name

Hennepin County Medical Center

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55415

Country

United States

Facility Name

New Ulm Medical Center

City

New Ulm

State/Province

Minnesota

ZIP/Postal Code

56073

Country

United States

Facility Name

North Memorial Medical Health Center

City

Robbinsdale

State/Province

Minnesota

ZIP/Postal Code

55422

Country

United States

Facility Name

Metro Minnesota Community Oncology Research Consortium

City

Saint Louis Park

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

Facility Name

Park Nicollet Clinic - Saint Louis Park

City

Saint Louis Park

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

Facility Name

Regions Hospital

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55101

Country

United States

Facility Name

United Hospital

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55102

Country

United States

Facility Name

Saint Francis Regional Medical Center

City

Shakopee

State/Province

Minnesota

ZIP/Postal Code

55379

Country

United States

Facility Name

Lakeview Hospital

City

Stillwater

State/Province

Minnesota

ZIP/Postal Code

55082

Country

United States

Facility Name

Ridgeview Medical Center

City

Waconia

State/Province

Minnesota

ZIP/Postal Code

55387

Country

United States

Facility Name

Rice Memorial Hospital

City

Willmar

State/Province

Minnesota

ZIP/Postal Code

56201

Country

United States

Facility Name

Minnesota Oncology and Hematology PA-Woodbury

City

Woodbury

State/Province

Minnesota

ZIP/Postal Code

55125

Country

United States

Facility Name

Alegent Health Lakeside Hospital

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68130

Country

United States

Facility Name

Veterans Adminstration New Jersey Health Care System

City

East Orange

State/Province

New Jersey

ZIP/Postal Code

07018-1095

Country

United States

Facility Name

Hunterdon Medical Center

City

Flemington

State/Province

New Jersey

ZIP/Postal Code

08822

Country

United States

Facility Name

Rutgers New Jersey Medical School

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07101

Country

United States

Facility Name

Roger Maris Cancer Center

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58122

Country

United States

Facility Name

Sanford Clinic North-Fargo

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58122

Country

United States

Facility Name

Sanford Medical Center-Fargo

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58122

Country

United States

Facility Name

Summa Akron City Hospital/Cooper Cancer Center

City

Akron

State/Province

Ohio

ZIP/Postal Code

44304

Country

United States

Facility Name

Mary Rutan Hospital

City

Bellefontaine

State/Province

Ohio

ZIP/Postal Code

43311

Country

United States

Facility Name

Mercy Medical Center

City

Canton

State/Province

Ohio

ZIP/Postal Code

44708

Country

United States

Facility Name

Adena Regional Medical Center

City

Chillicothe

State/Province

Ohio

ZIP/Postal Code

45601

Country

United States

Facility Name

The Christ Hospital

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Case Western Reserve University

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Riverside Methodist Hospital

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43214

Country

United States

Facility Name

Columbus NCI Community Oncology Research Program

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

Grant Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

Mount Carmel Health Center West

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43222

Country

United States

Facility Name

Doctors Hospital

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43228

Country

United States

Facility Name

Grady Memorial Hospital

City

Delaware

State/Province

Ohio

ZIP/Postal Code

43015

Country

United States

Facility Name

Fairfield Medical Center

City

Lancaster

State/Province

Ohio

ZIP/Postal Code

43130

Country

United States

Facility Name

Saint Rita's Medical Center

City

Lima

State/Province

Ohio

ZIP/Postal Code

45801

Country

United States

Facility Name

Marietta Memorial Hospital

City

Marietta

State/Province

Ohio

ZIP/Postal Code

45750

Country

United States

Facility Name

Knox Community Hospital

City

Mount Vernon

State/Province

Ohio

ZIP/Postal Code

43050

Country

United States

Facility Name

Licking Memorial Hospital

City

Newark

State/Province

Ohio

ZIP/Postal Code

43055

Country

United States

Facility Name

Southern Ohio Medical Center

City

Portsmouth

State/Province

Ohio

ZIP/Postal Code

45662

Country

United States

Facility Name

Springfield Regional Medical Center

City

Springfield

State/Province

Ohio

ZIP/Postal Code

45505

Country

United States

Facility Name

Genesis Healthcare System Cancer Care Center

City

Zanesville

State/Province

Ohio

ZIP/Postal Code

43701

Country

United States

Facility Name

Bryn Mawr Hospital

City

Bryn Mawr

State/Province

Pennsylvania

ZIP/Postal Code

19010

Country

United States

Facility Name

Geisinger Medical Center

City

Danville

State/Province

Pennsylvania

ZIP/Postal Code

17822

Country

United States

Facility Name

PinnacleHealth Cancer Center-Community Campus

City

Harrisburg

State/Province

Pennsylvania

ZIP/Postal Code

17109

Country

United States

Facility Name

Geisinger Medical Center-Cancer Center Hazleton

City

Hazleton

State/Province

Pennsylvania

ZIP/Postal Code

18201

Country

United States

Facility Name

Saint Mary Medical and Regional Cancer Center

City

Langhorne

State/Province

Pennsylvania

ZIP/Postal Code

19047

Country

United States

Facility Name

Paoli Memorial Hospital

City

Paoli

State/Province

Pennsylvania

ZIP/Postal Code

19301

Country

United States

Facility Name

University of Pennsylvania/Abramson Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Albert Einstein Medical Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19141

Country

United States

Facility Name

University of Pittsburgh Cancer Institute (UPCI)

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

Pottstown Memorial Medical Center

City

Pottstown

State/Province

Pennsylvania

ZIP/Postal Code

19464

Country

United States

Facility Name

Geisinger Medical Group

City

State College

State/Province

Pennsylvania

ZIP/Postal Code

16801

Country

United States

Facility Name

Reading Hospital

City

West Reading

State/Province

Pennsylvania

ZIP/Postal Code

19611

Country

United States

Facility Name

Geisinger Wyoming Valley/Henry Cancer Center

City

Wilkes-Barre

State/Province

Pennsylvania

ZIP/Postal Code

18711

Country

United States

Facility Name

Lankenau Medical Center

City

Wynnewood

State/Province

Pennsylvania

ZIP/Postal Code

19096

Country

United States

Facility Name

Main Line Health NCORP

City

Wynnewood

State/Province

Pennsylvania

ZIP/Postal Code

19096

Country

United States

Facility Name

Avera Cancer Institute

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57105

Country

United States

Facility Name

Avera McKennan Hospital and University Health Center

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57105

Country

United States

Facility Name

Dallas VA Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

Facility Name

Parkland Memorial Hospital

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

UT Southwestern/Simmons Cancer Center-Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

University of Texas Health Science Center at San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

West Virginia University Charleston

City

Charleston

State/Province

West Virginia

ZIP/Postal Code

25304

Country

United States

Facility Name

Fox Valley Hematology and Oncology

City

Appleton

State/Province

Wisconsin

ZIP/Postal Code

54913

Country

United States

Facility Name

Marshfield Clinic Cancer Center at Sacred Heart

City

Eau Claire

State/Province

Wisconsin

ZIP/Postal Code

54701

Country

United States

Facility Name

Dean Hematology and Oncology Clinic

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53717

Country

United States

Facility Name

Froedtert and the Medical College of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Cancer Center of Western Wisconsin

City

New Richmond

State/Province

Wisconsin

ZIP/Postal Code

54017

Country

United States

Facility Name

Oconomowoc Memorial Hospital-ProHealth Care Inc

City

Oconomowoc

State/Province

Wisconsin

ZIP/Postal Code

53066

Country

United States

Facility Name

Waukesha Memorial Hospital

City

Waukesha

State/Province

Wisconsin

ZIP/Postal Code

53188

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.

Citations:

Citation

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.

Results Reference

result

PubMed Identifier

28950351

Citation

Argiris A, Lee JW, Stevenson J, Sulecki MG, Hugec V, Choong NW, Saltzman JN, Song W, Hansen RM, Evans TL, Ramalingam SS, Schiller JH. Phase II randomized trial of carboplatin, paclitaxel, bevacizumab with or without cixutumumab (IMC-A12) in patients with advanced non-squamous, non-small-cell lung cancer: a trial of the ECOG-ACRIN Cancer Research Group (E3508). Ann Oncol. 2017 Dec 1;28(12):3037-3043. doi: 10.1093/annonc/mdx534.

Results Reference

derived

Learn more about this trial

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

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

Large Cell Lung Carcinoma, Lung Adenocarcinoma, Recurrent Non-Small Cell Lung Carcinoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial