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

NCT ID: NCT00887159

Last Updated: 2021-01-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-16

Study Completion Date

2016-11-15

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVES:

I. To evaluate the progression-free survival (PFS) 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-1 receptor (IGF-1R) monoclonal antibody (IMC-A12) (cixutumumab).

SECONDARY OBJECTIVES:

I. To evaluate response rate, overall survival, and toxicity for each arm. 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 A (CE): Patients receive cisplatin (75 mg/m\^2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m\^2) 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 B (CE +GDC-0449): Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) 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 C (CE + IMC-A12): Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) 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.

Conditions

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Extensive Stage Small Cell Lung Carcinoma Recurrent Small Cell Lung Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A (CE)

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.

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

Given IV

Etoposide

Intervention Type DRUG

Given IV

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Arm B (CE + GDC-0449)

Patients receive cisplatin and etoposide as in Arm A 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.

Group Type EXPERIMENTAL

Cisplatin

Intervention Type DRUG

Given IV

Etoposide

Intervention Type DRUG

Given IV

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Vismodegib

Intervention Type DRUG

Given PO

Arm C (CE + IMC-A12)

Patients receive cisplatin and etoposide as in Arm A 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.

Group Type EXPERIMENTAL

Cisplatin

Intervention Type DRUG

Given IV

Cixutumumab

Intervention Type BIOLOGICAL

Given IV

Etoposide

Intervention Type DRUG

Given IV

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

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Cisplatin

Given IV

Intervention Type DRUG

Cixutumumab

Given IV

Intervention Type BIOLOGICAL

Etoposide

Given IV

Intervention Type DRUG

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Vismodegib

Given PO

Intervention Type DRUG

Other Intervention Names

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Abiplatin Blastolem Briplatin CDDP Cis-diammine-dichloroplatinum Cis-diamminedichloridoplatinum Cis-diamminedichloro Platinum (II) Cis-diamminedichloroplatinum Cis-dichloroammine Platinum (II) Cis-platinous Diamine Dichloride Cis-platinum Cis-platinum II Cis-platinum II Diamine Dichloride Cismaplat Cisplatina Cisplatinum Cisplatyl Citoplatino Citosin Cysplatyna DDP Lederplatin Metaplatin Neoplatin Peyrone's Chloride Peyrone's Salt Placis Plastistil Platamine Platiblastin Platiblastin-S Platinex Platinol Platinol- AQ Platinol-AQ Platinol-AQ VHA Plus Platinoxan Platinum Platinum Diamminodichloride Platiran Platistin Platosin Anti-IGF-1R Recombinant Monoclonal Antibody IMC-A12 IMC-A12 Demethyl Epipodophyllotoxin Ethylidine Glucoside EPEG Lastet Toposar Vepesid VP 16-213 VP-16 VP-16-213 Erivedge GDC-0449 Hedgehog Antagonist GDC-0449

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed small cell lung cancer (SCLC)
* Extensive stage SCLC

* Extensive stage disease: the extensive disease classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive disease patients are defined as those patients with extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy
* Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST); baseline measurements and evaluations of all sites of disease must be obtained =\< 4 weeks prior to randomization
* 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 institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase)/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase) =\< 3 x institutional ULN (=\< 5 x ULN if liver function test \[LFT\] elevations are due to liver metastases)
* Creatinine =\< 1.5 x institutional ULN OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels \> 1.5 x institutional ULN
* Leukocytes \>= 3,000/mm\^3
* Hemoglobin \>= 9 g/dL
* Fasting serum glucose \< 120 mg/dL or below institutional ULN =\< 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

* NOTE: the use of prophylactic cranial irradiation (recommended dose 25 Gy) in those who completed protocol chemotherapy and have a response (in the absence of progressive disease \[PD\]) is allowed; for patients on Arms B and C, GDC-0449 and IMC-A12 will be held while patient is receiving prophylactic cranial irradiation (PCI); these agents can be reinstituted after PCI is completed
* Women of child-bearing potential (WCBP) 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

* 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 WCBP 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

Exclusion Criteria

* Pregnant or breastfeeding; all WCBP must have a blood test within 10-14 days prior to randomization to rule out pregnancy
* 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
* Receiving any other investigational agents
* 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
* 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
* 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 with major surgery, hormonal therapy (other than replacement), within 4 weeks prior to entering the study or those who have not recovered from adverse events
* Prior treatment with other agents targeting the IGFR or the Hedgehog signaling pathway
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chandra Belani

Role: PRINCIPAL_INVESTIGATOR

ECOG-ACRIN Cancer Research Group

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Site Status

The Medical Center of Aurora

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Site Status

SCL Health Saint Joseph Hospital

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

Colorado Cancer Research Program NCORP

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Saint Anthony Hospital

Lakewood, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

Longmont United Hospital

Longmont, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Site Status

North Suburban Medical Center

Thornton, Colorado, United States

Site Status

SCL Health Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

Site Status

The Hospital of Central Connecticut

New Britain, Connecticut, United States

Site Status

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, United States

Site Status

Boca Raton Regional Hospital

Boca Raton, Florida, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status

Atlanta VA Medical Center

Decatur, Georgia, United States

Site Status

Medical Center of Central Georgia

Macon, Georgia, United States

Site Status

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

Savannah, Georgia, United States

Site Status

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Site Status

Graham Hospital Association

Canton, Illinois, United States

Site Status

Illinois CancerCare-Canton

Canton, Illinois, United States

Site Status

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Hematology and Oncology Associates

Chicago, Illinois, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Presence Saint Joseph Hospital-Chicago

Chicago, Illinois, United States

Site Status

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status

Heartland Cancer Research NCORP

Decatur, Illinois, United States

Site Status

Elmhurst Memorial Hospital

Elmhurst, Illinois, United States

Site Status

Eureka Hospital

Eureka, Illinois, United States

Site Status

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Site Status

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Site Status

Ingalls Memorial Hospital

Harvey, Illinois, United States

Site Status

Illinois CancerCare-Havana

Havana, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hematology Oncology Associates of Illinois-Highland Park

Highland Park, Illinois, United States

Site Status

Hinsdale Hematology Oncology Associates Incorporated

Hinsdale, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates Limited

Joliet, Illinois, United States

Site Status

Presence Saint Mary's Hospital

Kankakee, Illinois, United States

Site Status

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Site Status

NorthShore Hematology Oncology-Libertyville

Libertyville, Illinois, United States

Site Status

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Site Status

Mcdonough District Hospital

Macomb, Illinois, United States

Site Status

Garneau, Stewart C MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Porubcin, Michael MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Sharis, Christine M MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Spector, David MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Stoffel, Thomas J MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Trinity Medical Center

Moline, Illinois, United States

Site Status

Holy Family Medical Center

Monmouth, Illinois, United States

Site Status

Illinois CancerCare-Monmouth

Monmouth, Illinois, United States

Site Status

Illinois Cancer Specialists-Niles

Niles, Illinois, United States

Site Status

Bromenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center Foundation

Normal, Illinois, United States

Site Status

Illinois CancerCare-Community Cancer Center

Normal, Illinois, United States

Site Status

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status

Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, United States

Site Status

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Site Status

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

Pekin, Illinois, United States

Site Status

Pekin Hospital

Pekin, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status

Illinois CancerCare-Peru

Peru, Illinois, United States

Site Status

Illinois Valley Hospital

Peru, Illinois, United States

Site Status

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

Swedish American Hospital

Rockford, Illinois, United States

Site Status

SwedishAmerican Regional Cancer Center/ACT

Rockford, Illinois, United States

Site Status

Hematology Oncology Associates of Illinois - Skokie

Skokie, Illinois, United States

Site Status

Illinois CancerCare-Spring Valley

Spring Valley, Illinois, United States

Site Status

Saint Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Memorial Medical Center

Springfield, Illinois, United States

Site Status

McFarland Clinic PC-William R Bliss Cancer Center

Ames, Iowa, United States

Site Status

Constantinou, Costas L MD (UIA Investigator)

Bettendorf, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-West Des Moines

Clive, Iowa, United States

Site Status

Mercy Capitol

Des Moines, Iowa, United States

Site Status

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Site Status

Iowa-Wide Oncology Research Coalition NCORP

Des Moines, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-Laurel

Des Moines, Iowa, United States

Site Status

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Site Status

Iowa Lutheran Hospital

Des Moines, Iowa, United States

Site Status

Mercy Medical Center - North Iowa

Mason City, Iowa, United States

Site Status

Ottumwa Regional Health Center

Ottumwa, Iowa, United States

Site Status

Siouxland Regional Cancer Center

Sioux City, Iowa, United States

Site Status

Mercy Medical Center-Sioux City

Sioux City, Iowa, United States

Site Status

Saint Luke's Regional Medical Center

Sioux City, Iowa, United States

Site Status

Cancer Center of Kansas - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, United States

Site Status

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

Site Status

Cancer Center of Kansas-Independence

Independence, Kansas, United States

Site Status

Cancer Center of Kansas-Kingman

Kingman, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

Southwest Medical Center

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas-Liberal

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas - Newton

Newton, Kansas, United States

Site Status

Cancer Center of Kansas - Parsons

Parsons, Kansas, United States

Site Status

Cancer Center of Kansas - Pratt

Pratt, Kansas, United States

Site Status

Cancer Center of Kansas - Salina

Salina, Kansas, United States

Site Status

Cancer Center of Kansas - Wellington

Wellington, Kansas, United States

Site Status

Associates In Womens Health

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas - Wichita

Wichita, Kansas, United States

Site Status

Via Christi Regional Medical Center

Wichita, Kansas, United States

Site Status

Wichita NCI Community Oncology Research Program

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas - Winfield

Winfield, Kansas, United States

Site Status

Doctors Carrol, Sheth, Raghavan

Louisville, Kentucky, United States

Site Status

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Site Status

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Site Status

The Memorial Hospital at Easton

Easton, Maryland, United States

Site Status

Frederick Memorial Hospital

Frederick, Maryland, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Bixby Medical Center

Adrian, Michigan, United States

Site Status

Hickman Cancer Center

Adrian, Michigan, United States

Site Status

Michigan Cancer Research Consortium NCORP

Ann Arbor, Michigan, United States

Site Status

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Site Status

Beaumont Hospital-Dearborn

Dearborn, Michigan, United States

Site Status

Saint John Hospital and Medical Center

Detroit, Michigan, United States

Site Status

Hurley Medical Center

Flint, Michigan, United States

Site Status

Genesys Regional Medical Center-West Flint Campus

Flint, Michigan, United States

Site Status

Allegiance Health

Jackson, Michigan, United States

Site Status

Borgess Medical Center

Kalamazoo, Michigan, United States

Site Status

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

Sparrow Hospital

Lansing, Michigan, United States

Site Status

Saint Mary Mercy Hospital

Livonia, Michigan, United States

Site Status

Mercy Memorial Hospital

Monroe, Michigan, United States

Site Status

Toledo Clinic Cancer Centers-Monroe

Monroe, Michigan, United States

Site Status

Saint Joseph Mercy Oakland

Pontiac, Michigan, United States

Site Status

Lake Huron Medical Center

Port Huron, Michigan, United States

Site Status

Saint Mary's of Michigan

Saginaw, Michigan, United States

Site Status

Saint John Macomb-Oakland Hospital

Warren, Michigan, United States

Site Status

Sanford Clinic North-Bemidgi

Bemidji, Minnesota, United States

Site Status

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Site Status

Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status

Essentia Health Cancer Center

Duluth, Minnesota, United States

Site Status

Essentia Health Saint Mary's Medical Center

Duluth, Minnesota, United States

Site Status

Miller-Dwan Hospital

Duluth, Minnesota, United States

Site Status

Fairview-Southdale Hospital

Edina, Minnesota, United States

Site Status

Lake Region Healthcare Corporation-Cancer Care

Fergus Falls, Minnesota, United States

Site Status

Unity Hospital

Fridley, Minnesota, United States

Site Status

Hutchinson Area Health Care

Hutchinson, Minnesota, United States

Site Status

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Site Status

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Site Status

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Site Status

Metro Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, United States

Site Status

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Site Status

Regions Hospital

Saint Paul, Minnesota, United States

Site Status

United Hospital

Saint Paul, Minnesota, United States

Site Status

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Site Status

Lakeview Hospital

Stillwater, Minnesota, United States

Site Status

Ridgeview Medical Center

Waconia, Minnesota, United States

Site Status

Rice Memorial Hospital

Willmar, Minnesota, United States

Site Status

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Site Status

Nebraska Cancer Research Center

Lincoln, Nebraska, United States

Site Status

Missouri Valley Cancer Consortium

Omaha, Nebraska, United States

Site Status

Alegent Health Immanuel Medical Center

Omaha, Nebraska, United States

Site Status

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, United States

Site Status

Creighton University Medical Center

Omaha, Nebraska, United States

Site Status

Nevada Cancer Research Foundation CCOP

Las Vegas, Nevada, United States

Site Status

Veterans Adminstration New Jersey Health Care System

East Orange, New Jersey, United States

Site Status

Hunterdon Medical Center

Flemington, New Jersey, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Sparta Cancer Treatment Center

Sparta, New Jersey, United States

Site Status

Lovelace Medical Center-Saint Joseph Square

Albuquerque, New Mexico, United States

Site Status

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status

Presbyterian Kaseman Hospital

Albuquerque, New Mexico, United States

Site Status

New York Oncology Hematology PC - Albany

Albany, New York, United States

Site Status

New York Oncology Hematology PC -Albany Medical Center

Albany, New York, United States

Site Status

New York Oncology Hematology PC - Amsterdam

Amsterdam, New York, United States

Site Status

New York Oncology Hematology PC - Clifton Park

Clifton Park, New York, United States

Site Status

New York Oncology Hematology PC-Hudson

Hudson, New York, United States

Site Status

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Site Status

New York Oncology Hematology PC - Rexford

Rexford, New York, United States

Site Status

Stony Brook University Medical Center

Stony Brook, New York, United States

Site Status

Montefiore Medical Center-Weiler Hospital

The Bronx, New York, United States

Site Status

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Site Status

New York Oncology Hematology PC - Troy

Troy, New York, United States

Site Status

Dickstein Cancer Treatment Center

White Plains, New York, United States

Site Status

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Site Status

Sanford Clinic North-Fargo

Fargo, North Dakota, United States

Site Status

Summa Akron City Hospital/Cooper Cancer Center

Akron, Ohio, United States

Site Status

Summa Barberton Hospital

Barberton, Ohio, United States

Site Status

Mary Rutan Hospital

Bellefontaine, Ohio, United States

Site Status

Toledo Clinic Cancer Centers-Bowling Green

Bowling Green, Ohio, United States

Site Status

Mercy Medical Center

Canton, Ohio, United States

Site Status

Aultman Health Foundation

Canton, Ohio, United States

Site Status

Adena Regional Medical Center

Chillicothe, Ohio, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

North Coast Cancer Care-Clyde

Clyde, Ohio, United States

Site Status

Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status

Columbus NCI Community Oncology Research Program

Columbus, Ohio, United States

Site Status

Grant Medical Center

Columbus, Ohio, United States

Site Status

Mount Carmel Health Center West

Columbus, Ohio, United States

Site Status

Doctors Hospital

Columbus, Ohio, United States

Site Status

Grady Memorial Hospital

Delaware, Ohio, United States

Site Status

Hematology Oncology Center Incorporated

Elyria, Ohio, United States

Site Status

Mercy Cancer Center-Elyria

Elyria, Ohio, United States

Site Status

Fairfield Medical Center

Lancaster, Ohio, United States

Site Status

Saint Rita's Medical Center

Lima, Ohio, United States

Site Status

Lima Memorial Hospital

Lima, Ohio, United States

Site Status

Marietta Memorial Hospital

Marietta, Ohio, United States

Site Status

Saint Luke's Hospital

Maumee, Ohio, United States

Site Status

Toledo Clinic Cancer Centers-Maumee

Maumee, Ohio, United States

Site Status

Toledo Radiation Oncology at Northwest Ohio Onocolgy Center

Maumee, Ohio, United States

Site Status

Knox Community Hospital

Mount Vernon, Ohio, United States

Site Status

Licking Memorial Hospital

Newark, Ohio, United States

Site Status

Fisher-Titus Medical Center

Norwalk, Ohio, United States

Site Status

Saint Charles Hospital

Oregon, Ohio, United States

Site Status

Toledo Clinic Cancer Centers-Oregon

Oregon, Ohio, United States

Site Status

North Coast Cancer Care

Sandusky, Ohio, United States

Site Status

Springfield Regional Medical Center

Springfield, Ohio, United States

Site Status

Flower Hospital

Sylvania, Ohio, United States

Site Status

Mercy Hospital of Tiffin

Tiffin, Ohio, United States

Site Status

The Toledo Hospital/Toledo Children's Hospital

Toledo, Ohio, United States

Site Status

Saint Vincent Mercy Medical Center

Toledo, Ohio, United States

Site Status

University of Toledo

Toledo, Ohio, United States

Site Status

Toledo Community Hospital Oncology Program CCOP

Toledo, Ohio, United States

Site Status

Mercy Saint Anne Hospital

Toledo, Ohio, United States

Site Status

Toledo Clinic Cancer Centers-Toledo

Toledo, Ohio, United States

Site Status

Fulton County Health Center

Wauseon, Ohio, United States

Site Status

Saint Ann's Hospital

Westerville, Ohio, United States

Site Status

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, United States

Site Status

Natalie Warren Bryant Cancer Center at Saint Francis

Tulsa, Oklahoma, United States

Site Status

Abington Memorial Hospital

Abington, Pennsylvania, United States

Site Status

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States

Site Status

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

Site Status

Butler Memorial Hospital

Butler, Pennsylvania, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Ephrata Cancer Center

Ephrata, Pennsylvania, United States

Site Status

Adams Cancer Center

Gettysburg, Pennsylvania, United States

Site Status

Cherry Tree Cancer Center

Hanover, Pennsylvania, United States

Site Status

Geisinger Medical Center-Cancer Center Hazleton

Hazleton, Pennsylvania, United States

Site Status

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Site Status

Saint Mary Medical and Regional Cancer Center

Langhorne, Pennsylvania, United States

Site Status

Lewistown Hospital

Lewistown, Pennsylvania, United States

Site Status

Paoli Memorial Hospital

Paoli, Pennsylvania, United States

Site Status

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Einstein Medical Center Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Guthrie Medical Group PC-Robert Packer Hospital

Sayre, Pennsylvania, United States

Site Status

Mercy Hospital

Scranton, Pennsylvania, United States

Site Status

Hematology and Oncology Associates of North East Pennsylvania

Scranton, Pennsylvania, United States

Site Status

Scranton Hematology Oncology

Scranton, Pennsylvania, United States

Site Status

Geisinger Medical Group

State College, Pennsylvania, United States

Site Status

Mount Nittany Medical Center

State College, Pennsylvania, United States

Site Status

Reading Hospital

West Reading, Pennsylvania, United States

Site Status

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Site Status

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Site Status

WellSpan Health-York Hospital

York, Pennsylvania, United States

Site Status

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

Site Status

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status

Avera McKennan Hospital and University Health Center

Sioux Falls, South Dakota, United States

Site Status

Medical X-Ray Center

Sioux Falls, South Dakota, United States

Site Status

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Site Status

Wellmont Medical Associates Oncology and Hematology-Bristol

Bristol, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Center Cool Springs

Franklin, Tennessee, United States

Site Status

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Dallas VA Medical Center

Dallas, Texas, United States

Site Status

Parkland Memorial Hospital

Dallas, Texas, United States

Site Status

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Site Status

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Site Status

Fredericksburg Oncology Inc

Fredericksburg, Virginia, United States

Site Status

West Virginia University Charleston

Charleston, West Virginia, United States

Site Status

West Virginia University Healthcare

Morgantown, West Virginia, United States

Site Status

Wheeling Hospital/Schiffler Cancer Center

Wheeling, West Virginia, United States

Site Status

Marshfield Clinic-Chippewa Center

Chippewa Falls, Wisconsin, United States

Site Status

Marshfield Clinic Cancer Center at Sacred Heart

Eau Claire, Wisconsin, United States

Site Status

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status

Dean Hematology and Oncology Clinic

Madison, Wisconsin, United States

Site Status

Marshfield Clinic

Marshfield, Wisconsin, United States

Site Status

Columbia Saint Mary's Water Tower Medical Commons

Milwaukee, Wisconsin, United States

Site Status

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, United States

Site Status

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States

Site Status

Ascension Saint Mary's Hospital

Rhinelander, Wisconsin, United States

Site Status

Marshfield Clinic-Rice Lake Center

Rice Lake, Wisconsin, United States

Site Status

Ascension Saint Michael's Hospital

Stevens Point, Wisconsin, United States

Site Status

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, United States

Site Status

Marshfield Clinic - Weston Center

Weston, Wisconsin, United States

Site Status

Marshfield Clinic - Wisconsin Rapids Center

Wisconsin Rapids, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

https://nctn-data-archive.nci.nih.gov/

Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2011-01917

Identifier Type: REGISTRY

Identifier Source: secondary_id

09-0679

Identifier Type: -

Identifier Source: secondary_id

ECOG-E1508

Identifier Type: -

Identifier Source: secondary_id

CDR0000640898

Identifier Type: -

Identifier Source: secondary_id

E1508

Identifier Type: OTHER

Identifier Source: secondary_id

E1508

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180820

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10CA021115

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2011-01917

Identifier Type: -

Identifier Source: org_study_id

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