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Cisplatin and Etoposide With or Without Vismodegib or Cixutumumab in Treating Patients With Extensive-Stage Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00887159
First received: April 22, 2009
Last updated: October 1, 2014
Last verified: June 2014
  Purpose

This randomized phase II trial studies cisplatin and etoposide to see how well they work when given with or without vismodegib or 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 or by stopping them from dividing. 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, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. 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.


Condition Intervention Phase
Extensive Stage Small Cell Lung Cancer
Recurrent Small Cell Lung Cancer
Biological: cixutumumab
Drug: vismodegib
Drug: cisplatin
Drug: etoposide
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Time from randomization to death or disease progression, whichever occurs first, assessed up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: From randomization to death or last known follow-up, assessed up to 3 years ] [ Designated as safety issue: No ]
    Kaplan-Meier curves will be used to compare overall survival in each arm.

  • Overall response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Overall response will be compared between each investigational treatment arm and the control arm.

  • Toxicity as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    For each arm, a 1-sided 0.10-level exact binomial test will be used to compare the grade 4-5 toxicity rate to an assumed control rate of 10%.


Enrollment: 169
Study Start Date: July 2009
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (cisplatin, etoposide)
Patients receive cisplatin IV over 1-2 hours on day 1 and etoposide IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm II (cisplatin, etoposide, vismodegib)
Patients receive cisplatin and etoposide as in Arm I and vismodegib PO QD on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
Drug: vismodegib
Given PO
Other Names:
  • Erivedge
  • GDC-0449
  • Hedgehog antagonist GDC-0449
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm III (cisplatin, etoposide, cixutumumab)
Patients receive cisplatin and etoposide as in Arm I and cixutumumab IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
Biological: cixutumumab
Given IV
Other Names:
  • anti-IGF-1R recombinant monoclonal antibody IMC-A12
  • IMC-A12
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the progression-free survival of patients with extensive stage small cell lung cancer (SCLC-ED) treated with cisplatin and etoposide (CE), CE with hedgehog (HH) inhibitor GDC-0449 (vismodegib), and CE with Insulin-like Growth Factor-I Receptor (IGF-1R) Monoclonal Antibody (IMC-A12) (cixutumumab).

SECONDARY OBJECTIVES:

I. To evaluate response rate, overall survival, and toxicity of patients with SCLC-ED treated with CE, CE with GDC-0449, and CE with IMC-A12.

II. To explore putative correlates of clinical benefit from combination therapy in tumor and circulating tumor cells in patients treated on this protocol.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive cisplatin intravenously (IV) over 1-2 hours on day 1 and etoposide IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive cisplatin and etoposide as in Arm I and vismodegib orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.

ARM III: Patients receive cisplatin and etoposide as in Arm I and cixutumumab IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly 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 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed small cell lung cancer
  • Patients must have extensive stage SCLC
  • Patients must have measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelets >= 100,000/mm^3
  • Total bilirubin =< 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase)/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase) =< 3 X institutional upper limit of normal (ULN) (=< 5 X ULN if liver function test [LFT] elevations are due to liver metastases)
  • Creatinine =< 1.5 X institutional upper limit of normal (ULN) OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 x institutional upper limit of normal (ULN)
  • Leukocytes >= 3,000/mm^3
  • Hemoglobin >= 9 g/dL
  • Fasting serum glucose < 120 mg/dL or below institutional upper limit of normal =< 7 days prior to protocol randomization
  • Patients with central nervous system (CNS) metastases will be eligible if they have completed a course of CNS radiotherapy and have stable neurologic function for a minimum of 28 days prior to study randomization; radiotherapy must have been completed a minimum of 28 days prior to randomization, and patients must have recovered from any adverse events related to the radiotherapy (except alopecia and grade 1 neuropathy) and have stable neurologic function for a minimum of 28 days prior to study randomization
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation

    • Women of childbearing potential (WCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse; the two methods of reliable contraception must include one highly effective method (i.e., intrauterine device [IUD], hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e., latex condom, diaphragm, cervical cap); WCBP must be referred to a qualified provider of contraceptive methods if needed

      • NOTE: The WCBP randomized to Arm B must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following two additional time periods related to this study: 1) while participating in the study; and 2) for at least 12 months after discontinuation from the study
    • Before starting the study drugs, all WCBP must have a negative pregnancy test (sensitivity of at least 50 mIU/mL); the pregnancy test must be performed within 10-14 days prior to randomization

      • NOTE: The WCBP randomized to Arm B must have a second pregnancy test performed within the 24 hours prior to the start of the GDC-0449; the subject may not receive GDC-0449 until the investigator has verified that the results of these pregnancy tests are negative
    • The WCBP randomized to Arm B will be warned that sharing the study drug is prohibited and will be counseled about pregnancy precautions and potential risks or fetal exposure; she must also agree to abstain from donating blood during study participation and at least 12 months after discontinuation from the study drug

      • NOTE: Male subjects randomized to Arm B must agree to use a latex condom during sexual contact with women of childbearing potential while participating in the study and for at least 12 months following discontinuation from the study even if he has undergone a successful vasectomy
    • Male subjects randomized to Arm B will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure; male subjects must agree to abstain from donating blood, semen, or sperm during study participation and for at least 3 months after discontinuation from the study drug
  • Women must not be pregnant or breastfeeding; all females of childbearing potential must have a blood test within 10-14 days prior to randomization to rule out pregnancy
  • Patients cannot have had prior chemotherapy or biologic therapy for SCLC; patients with prior radiation may be eligible or after palliative radiotherapy for other sites of disease; patients receiving prior radiation cannot start therapy within 14 days after completion of radiation, and must have recovered from adverse events attributed to radiation; no previous irradiation to the only site of measurable or evaluable disease, unless that site had subsequent evidence of progression
  • Patients may not be receiving any other investigational agents
  • Patients must NOT have history of allergic reactions attributed to compounds of similar chemical or biological composition to GDC-0449 and IMC-A12 or other agents used in the study
  • Patients must NOT have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
  • Patient must not have poorly controlled diabetes mellitus; patients with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range (fasting < 120 mg/dL or below institutional upper limit of normal) and that they are on a stable dietary or therapeutic regimen for this condition
  • Patients who have had major surgery, hormonal therapy (other than replacement), within 4 weeks prior to entering the study or those who have not recovered from adverse events are not eligible
  • The patient must not have a history of treatment with other agents targeting the IGFR or the Hedgehog signaling pathway
  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: NCT00887159

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, California
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
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
Rose Medical Center
Denver, Colorado, United States, 80220
Exempla Saint Joseph Hospital
Denver, Colorado, United States, 80218
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Colorado Cancer Research Program CCOP
Denver, Colorado, United States, 80224-2522
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
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
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
United States, Florida
Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
United States, Georgia
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Illinois
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61701
Graham Hospital Association
Canton, Illinois, United States, 61520
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Memorial Hospital
Carthage, Illinois, United States, 62321
Rush University Medical Center
Chicago, Illinois, United States, 60612
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States, 60612-3785
Northwestern University
Chicago, Illinois, United States, 60611
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Elmhurst Memorial Hospital
Elmhurst, Illinois, United States, 60126
Eureka Hospital
Eureka, Illinois, United States, 61530
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Illinois CancerCare Galesburg
Galesburg, Illinois, United States, 61401
Illinois CancerCare-Havana
Havana, Illinois, United States, 62644
Mason District Hospital
Havana, Illinois, United States, 62644
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, United States, 60035
Presence Saint Mary's Hospital
Kankakee, Illinois, United States, 60901
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
North Shore Hematology Oncology
Libertyville, Illinois, United States, 60048
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Mcdonough District Hospital
Macomb, Illinois, United States, 61455
Trinity Medical Center
Moline, Illinois, United States, 61265
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, United States, 61265
Sharis, Christine M MD (UIA Investigator)
Moline, Illinois, United States, 61265
Spector, David MD (UIA Investigator)
Moline, Illinois, United States, 61265
Stoffel, Thomas J MD (UIA Investigator)
Moline, Illinois, United States, 61265
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, United States, 61265
Holy Family Medical Center
Monmouth, Illinois, United States, 61462
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States, 61462
Illinois Cancer Specialists-Niles
Niles, Illinois, United States, 60714
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Bromenn Regional Medical Center
Normal, Illinois, United States, 61761
Illinois CancerCare-Community Cancer Center
Normal, Illinois, United States, 61761
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States, 61350
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61554
Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Pekin Hospital
Pekin, Illinois, United States, 61554
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Illinois Oncology Research Association CCOP
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Proctor Hospital
Peoria, Illinois, United States, 61614
Illinois Valley Hospital
Peru, Illinois, United States, 61354
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois, United States, 61107
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, United States, 60076
Saint Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, United States, 61362
Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, United States, 52722
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Iowa Oncology Research Association CCOP
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 Capitol
Des Moines, Iowa, United States, 50307
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
Ottumwa Regional Health Center
Ottumwa, Iowa, United States, 52501
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
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 - 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
Wichita CCOP
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Kentucky
Doctors Carrol, Sheth, Raghavan
Louisville, Kentucky, United States, 40215
United States, Maryland
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
United States, Michigan
Bixby Medical Center
Adrian, Michigan, United States, 49221
Hickman Cancer Center
Adrian, Michigan, United States, 49221
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Hurley Medical Center
Flint, Michigan, United States, 48502
Allegiance Health
Jackson, Michigan, United States, 49201
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Mercy Memorial Hospital
Monroe, Michigan, United States, 48162
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
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
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Essentia Health Duluth Clinic CCOP
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
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, United States, 56537
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
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Metro-Minnesota CCOP
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
Nebraska Cancer Research Center
Lincoln, Nebraska, United States, 68510
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
United States, Nevada
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Hunterdon Medical Center
Flemington, New Jersey, United States, 08822
Hackensack University Medical CCOP
Hackensack, New Jersey, United States, 07601
Sparta Cancer Treatment Center
Sparta, New Jersey, United States, 07871
United States, New York
New York Oncology Hematology PC - Albany
Albany, New York, United States, 12206
New York Oncology Hematology PC -Albany Medical Center
Albany, New York, United States, 12208
New York Oncology Hematology PC - Amsterdam
Amsterdam, New York, United States, 12010
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Montefiore Medical Center - Moses Campus
Bronx, New York, United States, 10467-2490
New York Oncology Hematology PC-Hudson
Hudson, New York, United States, 12534
New York Oncology Hematology PC - Latham
Latham, New York, United States, 12110
New York University Langone Medical Center
New York, New York, United States, 10016
New York Oncology Hematology PC - Rexford
Rexford, New York, United States, 12148
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
New York Oncology Hematology PC - Troy
Troy, New York, United States, 12180
Dickstein Cancer Treatment Center
White Plains, New York, United States, 10601
United States, North Dakota
Sanford Clinic North-Fargo
Fargo, North Dakota, United States, 58122
Sanford Medical Center-Fargo
Fargo, North Dakota, United States, 58122
United States, Ohio
Mary Rutan Hospital
Bellefontaine, Ohio, United States, 43311
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States, 43402
Aultman Health Foundation
Canton, Ohio, United States, 44710
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Case Western Reserve University
Cleveland, Ohio, United States, 44106
North Coast Cancer Care-Clyde
Clyde, Ohio, United States, 43410
Columbus CCOP
Columbus, Ohio, United States, 43215
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
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
Hematology Oncology Center Incorporated
Elyria, Ohio, United States, 44035
Mercy Cancer Center-Elyria
Elyria, Ohio, United States, 44035
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Saint Luke's Hospital
Maumee, Ohio, United States, 43537
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States, 43537
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States, 43537
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Fisher-Titus Medical Center
Norwalk, Ohio, United States, 44857
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States, 43616
Saint Charles Hospital
Oregon, Ohio, United States, 43616
North Coast Cancer Care
Sandusky, Ohio, United States, 44870
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Flower Hospital
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
University of Toledo
Toledo, Ohio, United States, 43614
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States, 43606
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States, 43623
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States, 43617
Mercy Saint Anne Hospital
Toledo, Ohio, United States, 43623
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Saint Ann's Hospital
Westerville, Ohio, United States, 43081
Genesis HealthCare System
Zanesville, Ohio, United States, 43701
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
Butler Memorial Hospital
Butler, Pennsylvania, United States, 16001
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Ephrata Cancer Center
Ephrata, Pennsylvania, United States, 17522
Adams Cancer Center
Gettysburg, Pennsylvania, United States, 17325
Cherry Tree Cancer Center
Hanover, Pennsylvania, United States, 17331
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States, 18201
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
Saint Mary Medical and Regional Cancer Center
Langhorne, Pennsylvania, United States, 19047
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, United States, 18840
Scranton Hematology Oncology
Scranton, Pennsylvania, United States, 18510
Hematology and Oncology Associates of North East Pennsylvania
Scranton, Pennsylvania, United States, 18508
Mercy Hospital
Scranton, Pennsylvania, United States, 18501
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18711
WellSpan Health-York Hospital
York, Pennsylvania, United States, 17405
United States, South Dakota
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Wellmont Medical Associates Oncology and Hematology-Bristol
Bristol, Tennessee, United States, 37620
Vanderbilt-Ingram Cancer Center Cool Springs
Franklin, Tennessee, United States, 37067
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States, 22401
United States, West Virginia
West Virginia University Charleston
Charleston, West Virginia, United States, 25304
Wheeling Hospital
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, United States, 54729
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States, 54701
Gundersen Lutheran
La Crosse, Wisconsin, United States, 54601
Dean Hematology and Oncology Clinic
Madison, Wisconsin, United States, 53717
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Medical Consultants Limited
Milwaukee, Wisconsin, United States, 53215
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
Oconomowoc Memorial Hospital-ProHealth Care Inc
Oconomowoc, Wisconsin, United States, 53066-3896
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, United States, 54501
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States, 54868
Marshfield Clinic Cancer Care at Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Waukesha Memorial Hospital - ProHealth Care
Waukesha, Wisconsin, United States, 53188
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494
Sponsors and Collaborators
Investigators
Principal Investigator: Chandra Belani ECOG-ACRIN Cancer Research Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00887159     History of Changes
Other Study ID Numbers: NCI-2011-01917, NCI-2011-01917, ECOG-E1508, CDR0000640898, E1508, E1508, U10CA021115, U10CA180820
Study First Received: April 22, 2009
Last Updated: October 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cisplatin
Etoposide
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014