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COMPLETED
NCT00887159
PHASE2

A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients With Extensive Stage

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This randomized phase II trial studies cisplatin and etoposide to see how well they work when given with or without Hedgehog inhibitor GDC-0449 (vismodegib) or IGF-1R MOAB IMC-A12 (cixutumumab) in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin, 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. Etoposide may slow the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vismodegib may slow the growth of tumor cells. Monoclonal antibodies, such as cixutumumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving cisplatin and etoposide are more effective when given together with vismodegib or cixutumumab in treating small cell lung cancer.

Official title: A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients With Extensive Stage Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

168

Start Date

2009-07-16

Completion Date

2016-11-15

Last Updated

2026-06-24

Healthy Volunteers

No

Interventions

DRUG

Cisplatin

Given IV

BIOLOGICAL

Cixutumumab

Given IV

DRUG

Etoposide

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Vismodegib

Given PO

Locations (301)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Boulder Community Hospital

Boulder, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Porter Adventist Hospital

Denver, Colorado, United States

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

SCL Health Saint Joseph Hospital

Denver, Colorado, United States

Rose Medical Center

Denver, Colorado, United States

Colorado Cancer Research Program NCORP

Denver, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

North Colorado Medical Center

Greeley, Colorado, United States

Saint Anthony Hospital

Lakewood, Colorado, United States

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

McKee Medical Center

Loveland, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

North Suburban Medical Center

Thornton, Colorado, United States

SCL Health Lutheran Medical Center

Wheat Ridge, Colorado, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

The Hospital of Central Connecticut

New Britain, Connecticut, United States

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, United States

Boca Raton Regional Hospital

Boca Raton, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Atlanta VA Medical Center

Decatur, Georgia, United States

Medical Center of Central Georgia

Macon, Georgia, United States

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

Savannah, Georgia, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Graham Hospital Association

Canton, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Memorial Hospital

Carthage, Illinois, United States

Hematology and Oncology Associates

Chicago, Illinois, United States

Northwestern University

Chicago, Illinois, United States

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Presence Saint Joseph Hospital-Chicago

Chicago, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Heartland Cancer Research NCORP

Decatur, Illinois, United States

Elmhurst Memorial Hospital

Elmhurst, Illinois, United States

Eureka Hospital

Eureka, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

Illinois CancerCare-Havana

Havana, Illinois, United States

Mason District Hospital

Havana, Illinois, United States

Hematology Oncology Associates of Illinois-Highland Park

Highland Park, Illinois, United States

Hinsdale Hematology Oncology Associates Incorporated

Hinsdale, Illinois, United States

Joliet Oncology-Hematology Associates Limited

Joliet, Illinois, United States

Presence Saint Mary's Hospital

Kankakee, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

NorthShore Hematology Oncology-Libertyville

Libertyville, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Mcdonough District Hospital

Macomb, Illinois, United States

Garneau, Stewart C MD (UIA Investigator)

Moline, Illinois, United States

Porubcin, Michael MD (UIA Investigator)

Moline, Illinois, United States

Sharis, Christine M MD (UIA Investigator)

Moline, Illinois, United States

Spector, David MD (UIA Investigator)

Moline, Illinois, United States

Stoffel, Thomas J MD (UIA Investigator)

Moline, Illinois, United States

Trinity Medical Center

Moline, Illinois, United States

Holy Family Medical Center

Monmouth, Illinois, United States

Illinois CancerCare-Monmouth

Monmouth, Illinois, United States

Illinois Cancer Specialists-Niles

Niles, Illinois, United States

Bromenn Regional Medical Center

Normal, Illinois, United States

Community Cancer Center Foundation

Normal, Illinois, United States

Illinois CancerCare-Community Cancer Center

Normal, Illinois, United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, United States

Illinois CancerCare-Pekin

Pekin, Illinois, United States

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

Pekin, Illinois, United States

Pekin Hospital

Pekin, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Proctor Hospital

Peoria, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Illinois CancerCare-Peru

Peru, Illinois, United States

Illinois Valley Hospital

Peru, Illinois, United States

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Perry Memorial Hospital

Princeton, Illinois, United States

Swedish American Hospital

Rockford, Illinois, United States

SwedishAmerican Regional Cancer Center/ACT

Rockford, Illinois, United States

Hematology Oncology Associates of Illinois - Skokie

Skokie, Illinois, United States

Illinois CancerCare-Spring Valley

Spring Valley, Illinois, United States

Saint Margaret's Hospital

Spring Valley, Illinois, United States

Memorial Medical Center

Springfield, Illinois, United States

McFarland Clinic PC-William R Bliss Cancer Center

Ames, Iowa, United States

Constantinou, Costas L MD (UIA Investigator)

Bettendorf, Iowa, United States

Medical Oncology and Hematology Associates-West Des Moines

Clive, Iowa, United States

Mercy Capitol

Des Moines, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Iowa-Wide Oncology Research Coalition NCORP

Des Moines, Iowa, United States

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, United States

Medical Oncology and Hematology Associates-Laurel

Des Moines, Iowa, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Iowa Lutheran Hospital

Des Moines, Iowa, United States

Mercy Medical Center - North Iowa

Mason City, Iowa, United States

Ottumwa Regional Health Center

Ottumwa, Iowa, United States

And 201 more locations on ClinicalTrials.gov