Pemetrexed Disodium or Erlotinib Hydrochloride as Second-Line Therapy in Treating Patients With Advanced Non-small Cell Lung Cancer

NCT ID: NCT00738881

Last Updated: 2015-10-29

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2014-12-31

Brief Summary

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This randomized phase III trial studies pemetrexed disodium to see how well it works compared with erlotinib hydrochloride as second-line therapy in treating patients with non-small cell lung cancer that has spread to other places in the body. Pemetrexed disodium and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pemetrexed disodium is more effective than erlotinib hydrochloride in treating advanced non-small cell lung cancer.

Detailed Description

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PRIMARY OBJECTIVES:

I. To evaluate whether there are differences in progression-free survival due to treatment with erlotinib (erlotinib hydrochloride) compared to pemetrexed (pemetrexed disodium) for subsets of previously treated non-small cell lung cancer (NSCLC) patients defined by epidermal growth factor receptor (EGFR)-fluorescent in situ hybridization (FISH) positive versus negativity.

SECONDARY OBJECTIVES:

I. Ascertain the presence or absence of true differences due to treatment in the objective clinical endpoints of overall survival, confirmed response rate, and adverse event profile for subsets of patients defined on the basis of the epidermal growth factor receptor (EGFR)-FISH positivity versus negativity.

II. Ascertain the presence or absence of true differences due to treatment in objective clinical endpoints (i.e., progression free survival, overall survival, confirmed response rate, and adverse event profile) for subsets of patients defined on the basis of the epidermal growth factor receptor (EGFR) expression as measured by immunohistochemistry (IHC).

III. Ascertain the presence or absence of true differences due to treatment in objective clinical endpoints (i.e., progression free survival, overall survival, confirmed response rate, and adverse event profile) for subsets of patients defined on the basis of the epidermal growth factor receptor (EGFR) gene mutation status (MUT).

IV. To evaluate the prognostic effect of EGFR copy number as measured by FISH separately by treatment arm, i.e., is there a difference in outcome for FISH(+) patients receiving erlotinib compared to FISH (-) patients receiving erlotinib, and similarly is there a difference in outcome for FISH(+) patients receiving pemetrexed compared to FISH (-) patients receiving pemetrexed.

V. To evaluate the prognostic effect of EGFR expression as measured by IHC separately by treatment arm, i.e., is there a difference in outcome for IHC(+) patients receiving erlotinib compared to IHC (-) patients receiving erlotinib, and similarly is there a difference in outcome for IHC(+) patients receiving pemetrexed compared to IHC (-)patients receiving pemetrexed.

VI. To evaluate the prognostic effect of EGFR mutation status separately by treatment arm, i.e., is there a difference in outcome for MUT(+) patients receiving erlotinib compared to MUT(-) patients receiving erlotinib, and similarly is there a difference in outcome for MUT(+) patients receiving pemetrexed compared to MUT(-) patients receiving pemetrexed.

VII. To prospectively test the hypothesis that functionally relevant polymorphisms in the genes encoding for pemetrexed targets, as well as genes encoding for one or more of the key enzymes involved in the transport, activation, and inactivation of pemetrexed, either singly or in combination, play a role in the efficacy and/or toxicity of pemetrexed.

VIII. To prospectively test the hypothesis that functionally relevant polymorphisms in the EGFR gene as well as genes encoding for one or more of the key enzymes involved in the metabolism of erlotinib, either singly or in combination, play a role in the efficacy and/or toxicity of erlotinib.

IX. Evaluate proteomic signatures in blood samples as predictors of survival and response to treatment with erlotinib.

X. To evaluate expression of thymidylate synthase, dihydrofolate reductase, phosphoribosylglycineamide (GAR) formyltransferase, and methylthioadenosine phosphorylase gene expression in tumor samples, as measured by IHC or quantitative polymerase chain reaction, as predictors of survival and response to treatment with pemetrexed.

XI. To evaluate proteomic signatures in blood samples of patients as predictors of response and survival to treatment with erlotinib.

XII. To evaluate the following variables measured in tumor samples, as predictors of response and survival to treatment with pemetrexed: Expression of thymidylate synthase, dihydrofolate reductase and GAR formyltransferase genes methylthioadenosine phosphorylase expression by IHC or quantitative polymerase chain reaction (PCR).

XIII. To evaluate the following variables measured in tumor samples, as predictors of response and survival to treatment with erlotinib: Rat sarcoma (Ras) mutational status, EGFR mutational status and, epithelial to mesenchymal transition (EMT) status (measured by E-cadherin expression and vimentin expression) by IHC.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive pemetrexed disodium intravenously (IV) over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.

Conditions

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Recurrent Non-Small Cell Lung Carcinoma Stage IIIA Non-Small Cell Lung Cancer Stage IIIB Non-Small Cell Lung Cancer Stage IV Non-Small Cell Lung Cancer

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 I (erlotinib hydrochloride)

Patients receive erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

Erlotinib Hydrochloride

Intervention Type DRUG

Given PO

Arm II (pemetrexed disodium)

Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

Pemetrexed Disodium

Intervention Type DRUG

Given IV

Interventions

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Erlotinib Hydrochloride

Given PO

Intervention Type DRUG

Pemetrexed Disodium

Given IV

Intervention Type DRUG

Other Intervention Names

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Cp-358,774 OSI-774 Tarceva Alimta LY231514 N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt

Eligibility Criteria

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Inclusion Criteria

* Documented recurrence or disease progression of NSCLC

* NSCLC must be confirmed by pathologic examination, either on initial diagnosis or disease recurrence/progression; mixed histology allowed if all components consistent with NSCLC
* Measurable disease, defined as at least one lesion whose longest diameter can be accurately measured as \>= 2.0 cm by conventional techniques or as \>= 1.0 cm by spiral computed tomography (CT); if spiral CT is used, it must be used for both pre- and post- treatment tumor assessments
* Prior radiation therapy is permitted as long as:

* Recovered from the toxic effects of radiation treatment before study entry, except for alopecia
* =\< 25% of bone marrow radiated
* Presence of measurable disease whether in-field disease progression/recurrence or disease outside the treatment fields of radiation port
* Absolute neutrophil count (ANC) \>= 1,500 uL
* Platelet (PLT) \>= 100,000 uL
* Hemoglobin (Hgb) \>= 10 g/dL
* Total bilirubin: within normal institutional limits (WNL) OR direct bilirubin =\< upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
* International normalized ratio (INR) =\< 1.5
* Calculated creatinine clearance \>= 45 mL/min using the Cockcroft-Gault formula
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
* Negative pregnancy test done =\< 7 days prior to pre-registration, for women of childbearing potential only
* Ability to provide informed consent
* Life expectancy \>= 12 weeks
* Tissue available and willing to submit tissue for central pathology review and EGFR evaluation; performed on original diagnostic/recurrent tissue (preferably paraffin-embedded tissue blocks); if institution unable to release tissue blocks, willing to submit 25 unstained slides (15 sections cut at 5 microns mounted on charged slides and 10 sections cut at 10 microns mounted on uncharged slides)
* Must be previously treated for advanced disease with only 1 chemotherapy regimen which must contain cytotoxic agent(s); adjuvant/neoadjuvant treatment with cytotoxic agent(s) administered \< 12 months (from date chemotherapy was started) prior to pre-registration will be considered as one prior treatment; NOTE: adjuvant/neoadjuvant treatment administered \>= 12 months, use of targeted agents such as monoclonal antibodies prior to pre-registration will NOT be counted as one prior treatment; patient could have had adjuvant/neoadjuvant chemotherapy \>= 12 months and 1 systemic chemotherapy regimen for metastatic or recurrent disease
* Able to take folic acid, vitamin B12 supplementation, and dexamethasone
* Able to permanently discontinue aspirin dose of \>= 1.3 grams/day \>= 10 days before and after pemetrexed treatment
* Fertile patients must use effective contraception
* Able to take folic acid, vitamin B\_12 supplementation, and dexamethasone
* Stable brain metastasis that have been treated with either whole brain radiation therapy or gamma knife surgery and are off steroid treatment for \> 14 days prior to pre-registration, if applicable
* Willingness to return to enrolling institution for treatment and follow-up

Exclusion Criteria

* Any of the following:

* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
* Any clinically significant infection, at the treating physician's discretion
* Known human immunodeficiency virus (HIV) positive patients
* Impairment of gastrointestinal (GI) function, inability to swallow pills in the absence of a feeding tube, or GI disease that may significantly alter absorption of oral medications (e.g. ulcerative disease, uncontrolled nausea and vomiting, malabsorption syndromes, bowel obstruction, etc)
* Serious condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study or increase the risk for serious adverse events
* Any of the following prior therapies:

* Prior radiation to \> 25% of bone marrow
* EGFR tyrosine kinase inhibitors
* Pemetrexed
* Chemotherapy =\< 3 weeks prior to pre-registration
* Mitomycin C/nitrosoureas =\< 6 weeks prior to pre-registration
* Immunotherapy =\< 2 weeks prior to pre-registration
* Biologic therapy =\< 2 weeks prior to pre-registration
* Gene therapy =\< 2 weeks prior to pre-registration
* Full field radiation therapy =\< 4 weeks prior to pre-registration
* Limited field radiation therapy =\< 2 weeks prior to pre-registration
* Major surgery (i.e., laparotomy), open biopsy, or significant traumatic injury =\< 4 weeks prior to pre-registration or anticipation of need for major surgical procedure during the course of the study; minor surgery =\< 2 weeks prior to pre-registration; insertion of a vascular access device is not considered major or minor surgery in this regard
* Other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\]-approved indication and in the context of a research investigation) =\< 4 weeks prior to pre-registration
* Steroid therapy for brain metastasis =\< 14 days prior to pre-registration
* Symptomatic serosal effusion (\>= Common Terminology Criteria for Adverse Events \[CTCAE\] v3.0 grade 2 dyspnea) that is not amenable to drainage prior to pre-registration
* Other invasive solid or hematologic malignancy; exceptions: prior malignancy was diagnosed and definitively treated \>= 5 years previously with no subsequent evidence of recurrence; patients with a history of low-grade (Gleason score =\< 6) localized prostate cancer will be eligible even if diagnosed \< 3 years prior to pre-registration; these patients may continue on medications concomitantly to maintain their disease remission as necessary; patients with carcinoma in situ, regardless of organ involvement, or non-melanoma cutaneous carcinomas are eligible if these were definitively treated \>= 3 years previously with no subsequent evidence of recurrence; Note: patients with breast cancer that was definitively treated \> 5 years earlier but continue to receive aromatase inhibitors are NOT eligible
* Only non-measurable disease, defined as all other lesions, including small lesions whose longest diameter measures \< 2 cm with conventional techniques or \< 1.0 cm with spiral CT, and truly non-measurable lesions, which include the following as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria dated June 1999:

* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Inflammatory breast disease
* Lymphangitis cutis/pulmonis
* Abdominal masses that are not confirmed and followed by imaging techniques
* Cystic lesions
* Single disease site in prior radiation field
* Any of the following concurrent severe and/or uncontrolled medical conditions:

* Angina pectoris
* History of congestive heart failure =\< 3 months prior to pre-registration, unless ejection fraction \> 40%
* Myocardial infarction =\< 6 months prior to pre-registration
* Cardiac arrhythmia
* Diabetes mellitus
* Hypertension
* Any other severe underlying diseases which are, in the judgment of the investigator, inappropriate for entry into this study
* Respiratory symptoms \> CTCAE grade 1
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer and Leukemia Group B

NETWORK

Sponsor Role collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role collaborator

NCIC Clinical Trials Group

NETWORK

Sponsor Role collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alex Adjei

Role: PRINCIPAL_INVESTIGATOR

Alliance for Clinical Trials in Oncology

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Sparks Regional Medical Center

Fort Smith, Arkansas, United States

Site Status

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

Site Status

Kaiser Permanente-Fremont

Fremont, California, United States

Site Status

Fremont - Rideout Cancer Center

Marysville, California, United States

Site Status

Kaiser Permanente-Oakland

Oakland, California, United States

Site Status

Valley Care Health System - Pleasanton

Pleasanton, California, United States

Site Status

Kaiser Permanente-Redwood City

Redwood City, California, United States

Site Status

Kaiser Permanente-Richmond

Richmond, California, United States

Site Status

Kaiser Permanente-Roseville

Roseville, California, United States

Site Status

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status

Kaiser Permanente-South Sacramento

Sacramento, California, United States

Site Status

Kaiser Permanente - Sacramento

Sacramento, California, United States

Site Status

Kaiser Permanente-San Francisco

San Francisco, California, United States

Site Status

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Site Status

Kaiser Permanente San Leandro

San Leandro, California, United States

Site Status

Kaiser Permanente-San Rafael

San Rafael, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Site Status

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Site Status

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Site Status

Kaiser Permanente-Stockton

Stockton, California, United States

Site Status

Tahoe Forest Cancer Center

Truckee, California, United States

Site Status

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Site Status

Kaiser Permanente-Vallejo

Vallejo, California, United States

Site Status

Kaiser Permanente-Walnut Creek

Walnut Creek, 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

Exempla Saint Joseph Hospital

Denver, Colorado, United States

Site Status

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

Colorado Cancer Research Program CCOP

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

Bristol Hospital

Bristol, Connecticut, United States

Site Status

Middlesex Hospital

Middletown, Connecticut, United States

Site Status

Lynn Regional Cancer Center - West

Boca Raton, Florida, United States

Site Status

Boca Raton Comprehensive Cancer Center

Boca Raton, Florida, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

MacNeal Hospital and Cancer Center

Berwyn, Illinois, United States

Site Status

Saint Joseph Medical Center

Bloomington, Illinois, 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

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status

Eureka Hospital

Eureka, Illinois, United States

Site Status

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Illinois CancerCare Galesburg

Galesburg, Illinois, United States

Site Status

Illinois CancerCare-Cottage

Galesburg, 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

Hopedale Medical Complex - Hospital

Hopedale, Illinois, United States

Site Status

Midwest Center for Hematology Oncology

Joliet, 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

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Holy Family Medical Center

Monmouth, Illinois, United States

Site Status

Illinois CancerCare-Monmouth

Monmouth, Illinois, United States

Site Status

DuPage Medical Group-Ogden

Naperville, 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

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

OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC

Peoria, Illinois, United States

Site Status

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status

Illinois Oncology Research Association CCOP

Peoria, Illinois, United States

Site Status

OSF Saint Francis Medical Center

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

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

Franciscan St. Francis Health-Beech Grove

Beech Grove, Indiana, United States

Site Status

Reid Hospital and Health Care Services

Richmond, Indiana, United States

Site Status

McFarland Clinic PC-William R Bliss Cancer Center

Ames, Iowa, United States

Site Status

Hematology Oncology Associates-Quad Cities

Bettendorf, Iowa, United States

Site Status

Cedar Rapids Oncology Association

Cedar Rapids, Iowa, United States

Site Status

Mercy Hospital

Cedar Rapids, Iowa, United States

Site Status

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-West Des Moines

Clive, Iowa, United States

Site Status

Genesis Medical Center - East Campus

Davenport, Iowa, United States

Site Status

Genesis Medical Center - West Campus

Davenport, 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 Oncology Research Association CCOP

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

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

Covenant Medical Center

Waterloo, Iowa, United States

Site Status

Hospital District Sixth of Harper County

Anthony, Kansas, United States

Site Status

Menorah Medical Center

Overland Park, Kansas, United States

Site Status

Saint Luke's South Hospital

Overland Park, Kansas, United States

Site Status

Shawnee Mission Medical Center-KCCC

Shawnee Mission, Kansas, United States

Site Status

Stormont-Vail Regional Health Center

Topeka, Kansas, United States

Site Status

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Site Status

The Memorial Hospital at Easton

Easton, Maryland, United States

Site Status

Cancer Trials Support Unit

Rockville, Maryland, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Steward Saint Elizabeth's Medical Center

Brighton, Massachusetts, United States

Site Status

Cape Cod Hospital

Hyannis, Massachusetts, United States

Site Status

Bixby Medical Center

Adrian, Michigan, United States

Site Status

Hickman Cancer Center

Adrian, Michigan, United States

Site Status

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Site Status

Michigan Cancer Research Consortium CCOP

Ann Arbor, Michigan, United States

Site Status

Bronson Battle Creek

Battle Creek, Michigan, United States

Site Status

Spectrum Health Big Rapids Hospital

Big Rapids, Michigan, United States

Site Status

Oakwood Hospital and Medical Center

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

Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, United States

Site Status

Mercy Health Saint Mary's

Grand Rapids, Michigan, United States

Site Status

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, United States

Site Status

Allegiance Health

Jackson, 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

Mercy Health Mercy Campus

Muskegon, Michigan, United States

Site Status

Saint Joseph Mercy Oakland

Pontiac, Michigan, United States

Site Status

Saint Joseph Mercy Port Huron

Port Huron, Michigan, United States

Site Status

Saint Mary's of Michigan

Saginaw, Michigan, United States

Site Status

Munson Medical Center

Traverse City, Michigan, United States

Site Status

Saint John Macomb-Oakland Hospital

Warren, Michigan, United States

Site Status

Metro Health Hospital

Wyoming, Michigan, 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

Hutchinson Area Health Care

Hutchinson, Minnesota, United States

Site Status

Meeker County Memorial Hospital

Litchfield, Minnesota, United States

Site Status

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Site Status

Minnesota Cooperative Group Outreach Program

Minneapolis, Minnesota, United States

Site Status

Virginia Piper Cancer Institute

Minneapolis, Minnesota, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Regions Hospital

Saint Paul, Minnesota, United States

Site Status

Rice Memorial Hospital

Willmar, Minnesota, United States

Site Status

Truman Medical Center

Kansas City, Missouri, United States

Site Status

Saint Luke's Cancer Institute

Kansas City, Missouri, United States

Site Status

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Site Status

Saint Joseph Health Center

Kansas City, Missouri, United States

Site Status

North Kansas City Hospital

Kansas City, Missouri, United States

Site Status

Research Medical Center

Kansas City, Missouri, United States

Site Status

Saint Luke's East - Lee's Summit

Lee's Summit, Missouri, United States

Site Status

Liberty Hospital

Liberty, Missouri, United States

Site Status

Liberty Radiation Oncology Center

Liberty, Missouri, United States

Site Status

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Site Status

Saint Louis University Hospital

St Louis, Missouri, United States

Site Status

Missouri Baptist Medical Center

St Louis, Missouri, United States

Site Status

Center for Cancer Care and Research

St Louis, Missouri, United States

Site Status

Montana Cancer Consortium NCORP

Billings, Montana, United States

Site Status

Northern Rockies Radiation Oncology Center

Billings, Montana, United States

Site Status

Saint Vincent Healthcare

Billings, Montana, United States

Site Status

Frontier Cancer Center and Blood Institute-Billings

Billings, Montana, United States

Site Status

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status

Bozeman Deaconess Cancer Center

Bozeman, Montana, United States

Site Status

Bozeman Deaconess Hospital

Bozeman, Montana, United States

Site Status

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, United States

Site Status

Berdeaux, Donald MD (UIA Investigator)

Great Falls, Montana, United States

Site Status

Great Falls Clinic

Great Falls, Montana, United States

Site Status

Northern Montana Hospital

Havre, Montana, United States

Site Status

Saint Peter's Community Hospital

Helena, Montana, United States

Site Status

Glacier Oncology PLLC

Kalispell, Montana, United States

Site Status

Kalispell Medical Oncology

Kalispell, Montana, United States

Site Status

Kalispell Regional Medical Center

Kalispell, Montana, United States

Site Status

Community Medical Hospital

Missoula, Montana, United States

Site Status

Montana Cancer Specialists

Missoula, Montana, United States

Site Status

Saint Patrick Hospital - Community Hospital

Missoula, Montana, United States

Site Status

Guardian Oncology and Center for Wellness

Missoula, Montana, United States

Site Status

CHI Health Good Samaritan

Kearney, Nebraska, 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

Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County

Mount Holly, New Jersey, United States

Site Status

Riverview Medical Center/Booker Cancer Center

Red Bank, New Jersey, United States

Site Status

Virtua West Jersey Hospital Voorhees

Voorhees Township, New Jersey, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

State University of New York Upstate Medical University

Syracuse, New York, United States

Site Status

Syracuse Veterans Administration Medical Center

Syracuse, New York, United States

Site Status

Wayne Memorial Hospital

Goldsboro, North Carolina, United States

Site Status

Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, United States

Site Status

Rutherford Hospital

Rutherfordton, North Carolina, United States

Site Status

Southeast Cancer Consortium-Upstate NCORP

Winston-Salem, North Carolina, United States

Site Status

Mid Dakota Clinic

Bismarck, North Dakota, United States

Site Status

Saint Alexius Medical Center

Bismarck, North Dakota, United States

Site Status

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Site Status

Altru Cancer Center

Grand Forks, North Dakota, United States

Site Status

Toledo Clinic Cancer Centers-Bowling Green

Bowling Green, Ohio, United States

Site Status

North Coast Cancer Care-Clyde

Clyde, Ohio, United States

Site Status

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Grandview Hospital

Dayton, Ohio, United States

Site Status

Good Samaritan Hospital - Dayton

Dayton, Ohio, United States

Site Status

Miami Valley Hospital

Dayton, Ohio, United States

Site Status

Samaritan North Health Center

Dayton, Ohio, United States

Site Status

Dayton CCOP

Dayton, Ohio, United States

Site Status

Hematology Oncology Center Incorporated

Elyria, Ohio, United States

Site Status

Blanchard Valley Hospital

Findlay, Ohio, United States

Site Status

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, United States

Site Status

Wayne Hospital

Greenville, Ohio, United States

Site Status

Kettering Medical Center

Kettering, Ohio, United States

Site Status

Lima Memorial Hospital

Lima, 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

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

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

Upper Valley Medical Center

Troy, Ohio, United States

Site Status

Fulton County Health Center

Wauseon, Ohio, United States

Site Status

Clinton Memorial Hospital

Wilmington, Ohio, United States

Site Status

Greene Memorial Hospital

Xenia, Ohio, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Geisinger Medical Center-Cancer Center Hazleton

Hazleton, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Mercy Hospital

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

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Site Status

AnMed Health Hospital

Anderson, South Carolina, United States

Site Status

Spartanburg Medical Center

Spartanburg, South Carolina, United States

Site Status

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Site Status

Danville Regional Medical Center

Danville, Virginia, United States

Site Status

Fredericksburg Oncology Inc

Fredericksburg, Virginia, United States

Site Status

Memorial Hospital Of Martinsville

Martinsville, Virginia, United States

Site Status

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

Site Status

Rocky Mountain Oncology

Casper, Wyoming, United States

Site Status

Welch Cancer Center

Sheridan, Wyoming, United States

Site Status

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Site Status

Countries

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

United States Canada

Other Identifiers

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

NCI-2009-00663

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000612010

Identifier Type: -

Identifier Source: secondary_id

NCCTG-N0723

Identifier Type: -

Identifier Source: secondary_id

CALGB-30802

Identifier Type: -

Identifier Source: secondary_id

CAN-NCIC-BRC4

Identifier Type: -

Identifier Source: secondary_id

N0723

Identifier Type: OTHER

Identifier Source: secondary_id

N0723

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180821

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10CA025224

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00663

Identifier Type: -

Identifier Source: org_study_id

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