Cisplatin and Etoposide Phosphate With or Without GDC-0449 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: December 3, 2012
Last verified: December 2012
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Purpose
This randomized phase II trial is studying cisplatin and etoposide phosphate to see how well they work when given with or without GDC-0449 or cixutumumab in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. GDC-0449 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 GDC-0449 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 phosphate |
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 IMCA12 for Patients With Extensive Stage Small Cell Lung Cancer |
Resource links provided by NLM:
Drug Information available for:
Cisplatin
Etoposide
Insulin-like growth factor I
Etoposide phosphate
Mecasermin rinfabate
Vismodegib
U.S. FDA Resources
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 (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 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%.
| Estimated Enrollment: | 170 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | January 2100 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I (cisplatin, etoposide phosphate)
Patients receive cisplatin IV over 1-2 hours on day 1 and etoposide phosphate 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:
Drug: etoposide phosphate
Given IV
Other Names:
|
|
Experimental: Arm II (cisplatin, etoposide phosphate, vismodegib)
Patients receive cisplatin and etoposide phosphate as in arm I and oral Hedgehog antagonist GDC-0449 once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive Hedgehog antagonist GDC-0449 alone once daily in the absence of disease progression or unacceptable toxicity.
|
Drug: vismodegib
Given orally
Other Names:
Drug: cisplatin
Given IV
Other Names:
Drug: etoposide phosphate
Given IV
Other Names:
|
|
Experimental: Arm III (cisplatin, etoposide phosphate, cixutumumab)
Patients receive cisplatin and etoposide phosphate 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:
Drug: cisplatin
Given IV
Other Names:
Drug: etoposide phosphate
Given IV
Other Names:
|
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate the progression-free survival of patients with extensive stage small cell lung cancer treated with cisplatin and etoposide with or without Hedgehog antagonist GDC-0449 or cixutumumab.
SECONDARY OBJECTIVES:
I. To evaluate the response rate in patients treated with these regimens. II. To evaluate the overall survival of patients treated with these regimens. III. To evaluate the toxicity of these regimens in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to gender. Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients receive cisplatin IV over 1-2 hours on day 1 and etoposide phosphate 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 phosphate as in arm I and oral Hedgehog antagonist GDC-0449 once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive Hedgehog antagonist GDC-0449 alone once daily in the absence of disease progression or unacceptable toxicity.
ARM III: Patients receive cisplatin and etoposide phosphate 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:
Histologically or cytologically confirmed small cell lung cancer (SCLC)
Extensive stage disease, as defined by any of the following criteria:
- Extrathoracic metastatic disease
- Malignant pleural effusion
- Bilateral or contralateral supraclavicular adenopathy
- Measurable disease based on RECIST criteria
CNS metastases allowed provided the patient has completed a course of CNS radiotherapy and has stable neurologic function for ≥ 28 days prior to randomization
- Prophylactic cranial irradiation allowed in those who have a response (in the absence of progressive disease)
- ECOG performance status 0-1
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Leukocyte count ≥ 3,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST/ALT ≤ 3 times ULN (≤ 5 times ULN if elevations are due to liver metastases)
- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
- Fasting serum glucose < 120 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method contraception for ≥ 28 days before, during, and for ≥ 12 months after completion of study treatment
No concurrent uncontrolled illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Uncontrolled cardiac arrhythmia
- Psychiatric illness or social situation that would limit compliance with study requirements
No poorly controlled diabetes mellitus
- History of diabetes mellitus allowed provided blood glucose is normal and the patient is on a stable dietary or therapeutic regimen
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to Hedgehog antagonist GDC-0449, cixutumumab, or other study agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No prior chemotherapy or biologic therapy for SCLC
- No prior therapy with other agents targeting the IGFR or the Hedgehog signaling pathway
No prior irradiation to the only site of measurable or evaluable disease unless that site had subsequent evidence of progression
- Prior palliative radiotherapy to other sites of disease allowed
- More than 14 days since prior radiotherapy (28 days for radiotherapy to the CNS) and recovered
- More than 4 weeks since prior major surgery or hormonal therapy (other than replacement therapy) and recovered
- No other concurrent investigational or anticancer agents
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887159
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| United States, Arizona | |
| Mayo Clinic in Arizona | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, California | |
| Stanford University | |
| 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 | |
| Saint Anthony Central Hospital | |
| Denver, Colorado, United States, 80204 | |
| Porter Adventist Hospital | |
| Denver, Colorado, United States, 80210 | |
| Colorado Cancer Research Program CCOP | |
| Denver, Colorado, United States, 80224-2522 | |
| Presbyterian - Saint Lukes Medical Center - Health One | |
| Denver, Colorado, United States, 80218 | |
| Exempla Saint Joseph Hospital | |
| Denver, Colorado, United States, 80218 | |
| Swedish Medical Center | |
| Englewood, Colorado, United States, 80110 | |
| Saint Mary's Hospital and Regional Medical Center | |
| Grand Junction, Colorado, United States, 81502 | |
| North Colorado Medical Center | |
| Greeley, Colorado, United States, 80631 | |
| 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 | |
| Atlanta, Georgia, United States, 30322 | |
| Veterans Administration Medical Center | |
| Decatur, Georgia, United States, 30033 | |
| Saint Joseph's-Candler Health System | |
| Savannah, Georgia, United States, 31405 | |
| United States, Illinois | |
| Illinois CancerCare-Bloomington | |
| Bloomington%, Illinois, United States, 61701 | |
| Illinois CancerCare-Canton | |
| Canton, Illinois, United States, 61520 | |
| Graham Hospital Association | |
| Canton, Illinois, United States, 61520 | |
| Illinois CancerCare-Carthage | |
| Carthage, Illinois, United States, 62321 | |
| Memorial Hospital | |
| Carthage, Illinois, United States, 62321 | |
| John H Stroger Jr Hospital of Cook County | |
| Chicago, Illinois, United States, 60612-3785 | |
| Hematology and Oncology Associates | |
| Chicago, Illinois, United States, 60611 | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| 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 | |
| Evanston CCOP-NorthShore University HealthSystem | |
| Evanston, Illinois, United States, 60201 | |
| Galesburg Clinic | |
| Galesburg, Illinois, United States, 61401 | |
| Galesburg Cottage Hospital | |
| 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 | |
| Provena 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 | |
| Spector, David MD (UIA Investigator) | |
| Moline, Illinois, United States, 61265 | |
| Stoffel, Thomas J MD (UIA Investigator) | |
| Moline, Illinois, United States, 61265 | |
| Sharis, Christine M MD (UIA Investigator) | |
| Moline, Illinois, United States, 61265 | |
| Garneau, Stewart C MD (UIA Investigator) | |
| Moline, Illinois, United States, 61265 | |
| Illinois CancerCare-Monmouth | |
| Monmouth, Illinois, United States, 61462 | |
| Holy Family Medical Center | |
| Monmouth, Illinois, United States, 61462 | |
| Illinois Cancer Specialists-Niles | |
| Niles, Illinois, United States, 60714 | |
| Illinois CancerCare-Community Cancer Center | |
| Normal, Illinois, United States, 61761 | |
| Bromenn Regional Medical Center | |
| Normal, Illinois, United States, 61761 | |
| Community Cancer Center Foundation | |
| 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, 61603 | |
| Pekin Cancer Treatment Center | |
| Pekin, Illinois, United States, 61554 | |
| Pekin Hospital | |
| Pekin, Illinois, United States, 61554 | |
| Illinois Oncology Research Association CCOP | |
| Peoria, Illinois, United States, 61615 | |
| Proctor Hospital | |
| Peoria, Illinois, United States, 61614 | |
| Illinois CancerCare-Peoria | |
| Peoria, Illinois, United States, 61615 | |
| Methodist Medical Center of Illinois | |
| Peoria, Illinois, United States, 61603 | |
| Illinois CancerCare-Peru | |
| Peru, Illinois, United States, 61354 | |
| Illinois Valley Hospital | |
| Peru, Illinois, United States, 61354 | |
| Illinois CancerCare-Princeton | |
| Princeton, Illinois, United States, 61356 | |
| Perry Memorial Hospital | |
| Princeton, Illinois, United States, 61356 | |
| Hematology Oncology Associates of Illinois - Skokie | |
| Skokie, Illinois, United States, 60076 | |
| Illinois CancerCare-Spring Valley | |
| Spring Valley, Illinois, United States, 61362 | |
| Saint Margaret's Hospital | |
| Spring Valley, Illinois, United States, 61362 | |
| Memorial Medical Center | |
| Springfield, Illinois, United States, 62781-0001 | |
| United States, Iowa | |
| McFarland Clinic | |
| 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 | |
| Mercy Medical Center - Des Moines | |
| Des Moines, Iowa, United States, 50314 | |
| Medical Oncology and Hematology Associates-Des Moines | |
| Des Moines, Iowa, United States, 50309 | |
| Iowa Oncology Research Association CCOP | |
| Des Moines, Iowa, United States, 50309 | |
| Medical Oncology and Hematology Associates | |
| Des Moines, Iowa, United States, 50314 | |
| Iowa Methodist Medical Center | |
| Des Moines, Iowa, United States, 50309 | |
| Mercy Capitol | |
| Des Moines, Iowa, United States, 50307 | |
| Iowa Lutheran Hospital | |
| Des Moines, Iowa, United States, 50316 | |
| Mercy Medical Center - North Iowa | |
| Mason City, Iowa, United States, 50401 | |
| Ottumwa Regional Health Center | |
| Ottumwa, Iowa, United States, 52501 | |
| Saint Luke's Regional Medical Center | |
| Sioux City, Iowa, United States, 51104 | |
| Mercy Medical Center-Sioux City | |
| 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 | |
| Associates In Womens Health | |
| Wichita, Kansas, United States, 67208 | |
| Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas - Main Office | |
| Wichita, Kansas, United States, 67214 | |
| Wichita CCOP | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas-Wichita Medical Arts Tower | |
| 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 | |
| Baltimore, Maryland, United States, 21287-8936 | |
| 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 | |
| Dearborn, Michigan, United States, 48123 | |
| Saint John Hospital and Medical Center | |
| Detroit, Michigan, United States, 48236 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48502 | |
| Genesys Regional Medical Center-West Flint Campus | |
| Flint, Michigan, United States, 48532 | |
| Allegiance Health | |
| Jackson, Michigan, United States, 49201 | |
| Bronson Methodist Hospital | |
| Kalamazoo, Michigan, United States, 49007 | |
| Borgess Medical Center | |
| Kalamazoo, Michigan, United States, 49001 | |
| 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 | |
| Mercy Memorial Hospital | |
| Monroe, Michigan, United States, 48162 | |
| Community Cancer Center of Monroe | |
| 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 | |
| Merit Care Clinic Bemidji | |
| Bemidji, Minnesota, United States, 56601 | |
| Fairview Ridges Hospital | |
| Burnsville, Minnesota, United States, 55337 | |
| Mercy Hospital | |
| Coon Rapids, Minnesota, United States, 55433 | |
| Saint Mary's Medical Center | |
| Duluth, Minnesota, United States, 55805 | |
| Miller-Dwan Hospital | |
| Duluth, Minnesota, United States, 55805 | |
| Essentia Health Duluth Clinic CCOP | |
| 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 | |
| Saint John's Hospital - Healtheast | |
| Maplewood, Minnesota, United States, 55109 | |
| Minnesota Oncology Hematology PA-Maplewood | |
| Maplewood, Minnesota, United States, 55109 | |
| Hennepin County Medical Center | |
| Minneapolis, Minnesota, United States, 55415 | |
| Abbott-Northwestern Hospital | |
| Minneapolis, Minnesota, United States, 55407 | |
| North Memorial Medical Health Center | |
| Robbinsdale, Minnesota, United States, 55422 | |
| Park Nicollet Clinic - Saint Louis Park | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Metro-Minnesota CCOP | |
| 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 | |
| Lincoln Medical Education Foundation Cancer Resource Center | |
| Lincoln, Nebraska, United States, 68510 | |
| Alegent Health Immanuel Medical Center | |
| Omaha, Nebraska, United States, 68122 | |
| Alegent Health Bergan Mercy Medical Center | |
| Omaha, Nebraska, United States, 68124 | |
| Creighton University Medical Center | |
| Omaha, Nebraska, United States, 68131 | |
| Missouri Valley Cancer Consortium CCOP | |
| 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 Medical Center | |
| Albany, New York, United States, 12208 | |
| New York Oncology Hematology PC - Albany | |
| Albany, New York, United States, 12206 | |
| New York Oncology Hematology PC - Amsterdam | |
| Amsterdam, New York, United States, 12010 | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10467-2490 | |
| Albert Einstein College of Medicine | |
| Bronx, New York, United States, 10461 | |
| 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 | |
| MeritCare Medical Group | |
| Fargo, North Dakota, United States, 58122 | |
| Meritcare Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| Mary Rutan Hospital | |
| Bellefontaine, Ohio, United States, 43311 | |
| Wood County Oncology Center | |
| 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 | |
| Riverside Methodist Hospital | |
| Columbus, Ohio, United States, 43214 | |
| Doctors Hospital | |
| Columbus, Ohio, United States, 43228 | |
| Grant Medical Center | |
| Columbus, Ohio, United States, 43215 | |
| Columbus CCOP | |
| Columbus, Ohio, United States, 43215 | |
| Mount Carmel Health Center West | |
| Columbus, Ohio, United States, 43222 | |
| Grady Memorial Hospital | |
| Delaware, Ohio, United States, 43015 | |
| Community Health Partners Regional Medical Center | |
| Elyria, Ohio, United States, 44035 | |
| Hematology Oncology Center Incorporated | |
| 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 | |
| Northwest Ohio Oncology Center | |
| Maumee, Ohio, United States, 43537-1839 | |
| 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 | |
| Saint Charles Hospital | |
| Oregon, Ohio, United States, 43616 | |
| Toledo Clinic Cancer Centers-Oregon | |
| 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 | |
| The Toledo Hospital | |
| Toledo, Ohio, United States, 43606 | |
| Mercy Cancer Center at Saint Anne Mercy Hospital | |
| Toledo, Ohio, United States, 43623 | |
| University of Toledo | |
| Toledo, Ohio, United States, 43614 | |
| Toledo Clinic | |
| Toledo, Ohio, United States, 43623 | |
| Toledo Community Hospital Oncology Program CCOP | |
| Toledo, Ohio, United States, 43617 | |
| Saint Vincent Mercy Medical Center | |
| Toledo, Ohio, United States, 43608 | |
| 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 Hazelton | |
| 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 | |
| Abramson Cancer Center of The University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Albert Einstein Medical Center | |
| Philadelphia, Pennsylvania, United States, 19141 | |
| Thomas Jefferson University Hospital | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Guthrie Clinic-Robert Packer Hospital | |
| Sayre, Pennsylvania, United States, 18840 | |
| Hematology and Oncology Associates of North East Pennsylvania | |
| Scranton, Pennsylvania, United States, 18508 | |
| Scranton Hematology Oncology | |
| Scranton, Pennsylvania, United States, 18510 | |
| Mercy Hospital | |
| Scranton, Pennsylvania, United States, 18501 | |
| Mount Nittany Medical Center | |
| State College, Pennsylvania, United States, 16803 | |
| Geisinger Medical Group | |
| State College, Pennsylvania, United States, 16801 | |
| Geisinger Wyoming Valley | |
| Wilkes-Barre, Pennsylvania, United States, 18711 | |
| York Hospital | |
| York, Pennsylvania, United States, 17405 | |
| United States, South Dakota | |
| Medical X-Ray Center | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Sanford University of South Dakota Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5134 | |
| Sanford Cancer Center-Oncology Clinic | |
| Sioux Falls, South Dakota, United States, 57104 | |
| 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, Tennessee | |
| Blue Ridge Medical Specialists PC | |
| Bristol, Tennessee, United States, 37620 | |
| Vanderbilt-Ingram Cancer Center Cool Springs | |
| Franklin, Tennessee, United States, 37067 | |
| Vanderbilt University | |
| 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 Care at Regional Cancer Center | |
| 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 | |
| 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 | Eastern Cooperative Oncology 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, ECOG-E1508, U10CA021115, CDR0000640898 |
| Study First Received: | April 22, 2009 |
| Last Updated: | December 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Antibodies, Monoclonal |
Etoposide phosphate Cisplatin Etoposide Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 21, 2013