Pancreas or Gastrointestinal Tract Cancer

EA2142



Cisplatin, Carboplatin and Etoposide or Temozolomide and Capecitabine in Treating Patients with Neuroendocrine Carcinoma of the Gastrointestinal Tract or Pancreas That Is Metastatic or Cannot Be Removed by Surgery

STATUS: Closed to Accrual and Intervention


This phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin or carboplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). Drugs used in chemotherapy, such as temozolomide, capecitabine, cisplatin, carboplatin and etoposide, 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. Certain types of neuroendocrine carcinomas may respond better to treatments other than the current standard treatment of cisplatin and etoposide. It is not yet known whether temozolomide and capecitabine may work better than cisplatin or carboplatin and etoposide in treating patients with this type of neuroendocrine carcinoma, called non-small cell neuroendocrine carcinoma.
  • Patients must have a locally advanced and unresectable or metastatic gastroenteropancreatic neuroendocrine carcinoma that is either known or suspected to be of gastrointestinal (GI) origin; primary tumors arising from the lung, gynecologic organs or prostate are not permitted

  • Patients must have pathologically/histologically confirmed tumor of non-small cell histology

  • Patients must have a Ki-67 proliferative index of 20-100% OR at least 10 mitotic figures per 10 high powered fields

  • Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; baseline measurements and evaluations of all sites of disease must be obtained within 4 weeks prior to randomization and must be acquired by multiphasic computed tomography (CT) or contrast magnetic resonance imaging (MRI) * NOTE: positron emission tomography (PET)-CT scans are allowed provided the CT portion of the exam is equivalent to a diagnostic CT scan and includes both oral and IV contrast

  • Patients may not have had any prior systemic treatment (chemotherapy, targeted therapy, peptide receptor radionuclide therapy [PRRT]); prior palliative radiation is permitted but radiated lesions may not be used for measurement

  • Patients may not have received any of the protocol agents within 5 years prior to randomization

  • Any prior surgeries must have been completed at least 4 weeks prior to randomization

  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

  • Patients may not be receiving any other investigational agents while on study treatment

  • Patients may not be receiving Coumadin while on treatment; other anticoagulants are allowed

  • Leukocytes >= 3,000/mm^3 (within less than or equal to 14 days prior to randomization)

  • Absolute neutrophil count >= 1,500/mm^3 (within less than or equal to 14 days prior to randomization)

  • Hemoglobin >= 9 g/dL (within less than or equal to 14 days prior to randomization)

  • Platelets >= 100,000/mm^3 (within less than or equal to 14 days prior to randomization)

  • Total bilirubin =< institutional upper limit of normal (ULN) or =< 1.5 x institutional ULN (if the patient has liver metastases) (within less than or equal to 14 days prior to randomization)

  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN or (=< 5 x institutional ULN if the patient has liver metastases) (within less than or equal to 14 days prior to randomization)

  • Serum creatinine =< 1.5 x institutional ULN and creatinine clearance >= 60 ml/min (within less than or equal to 14 days prior to randomization) * NOTE: creatinine clearance must be calculated using the Cockcroft-Gault equation

  • Patients must have a life expectancy of >= 12 weeks as determined clinically by the treating physician

  • Patients with brain metastases (either remote or current) or presence of carcinomatous meningitis are not eligible

  • Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency will be excluded as the use of capecitabine is contraindicated in these patients

  • Patients must NOT have active or uncontrolled infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia or a serious psychiatric illness/social situation that would limit compliance with study requirements

  • Patients with impaired decision making capacity may participate in the study if a legal authorized representative is available to consent

  • Patients must NOT have a history of allergic reactions attributed to compounds of similar chemical or biochemical composition to cisplatin, carboplatin, etoposide, temozolomide or capecitabine

  • Patients must NOT have absorption issues that would limit the ability to absorb study agents

  • Patients with a history of the following within =< 12 months of study entry are not eligible: * Arterial thromboembolic events * Unstable angina * Myocardial Infarction

  • Patients with symptomatic peripheral vascular disease are not eligible

  • Patients must NOT have previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions: * Non-melanoma skin cancer, in situ cervical cancer, superficial bladder cancer, or breast cancer in situ OR * Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years OR * Prior malignancy cured by non-surgical modalities and patient has been continuously disease free for > 5 years

  • Women must not be pregnant or breast-feeding due to potential harm to the fetus from cisplatin, carboplatin, etoposide, temozolomide and/or capecitabine * All females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy * A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

  • Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study

  • Patients must be able to swallow pills

  • Patients must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for the treatment and the protocol

  • Patients who are known to have human immunodeficiency virus (HIV) or are on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with cisplatin, carboplatin, etoposide, temozolomide, and/or capecitabine; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated

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Randallstown
Northwest Hospital Center
Contact: Site Public Contact
Email: [email protected]

Westminster
William E Kahlert Regional Cancer Center/Sinai Hospital
Contact: Site Public Contact

MI
Ann Arbor
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Contact: Site Public Contact
Email: [email protected]

University of Michigan Rogel Cancer Center
Contact: Site Public Contact

Battle Creek
Bronson Battle Creek
Contact: Site Public Contact
Email: [email protected]

Brighton
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Contact: Site Public Contact
Email: [email protected]

Trinity Health Medical Center - Brighton
Contact: Site Public Contact
Email: [email protected]

Brownstown
Henry Ford Cancer Institute-Downriver
Contact: Site Public Contact
Email: [email protected]

Canton
Trinity Health IHA Medical Group Hematology Oncology - Canton
Contact: Site Public Contact
Email: [email protected]

Trinity Health Medical Center - Canton
Contact: Site Public Contact
Email: [email protected]

Caro
Caro Cancer Center
Contact: Site Public Contact
Email: [email protected]

Chelsea
Chelsea Hospital
Contact: Site Public Contact
Email: [email protected]

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Contact: Site Public Contact
Email: [email protected]

Clarkston
Hematology Oncology Consultants-Clarkston
Contact: Site Public Contact
Email: [email protected]

Newland Medical Associates-Clarkston
Contact: Site Public Contact
Email: [email protected]

Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Contact: Site Public Contact
Email: [email protected]

Dearborn
Henry Ford Medical Center-Fairlane
Contact: Site Public Contact
Email: [email protected]

Detroit
Henry Ford Health Saint John Hospital
Contact: Site Public Contact
Email: [email protected]

Henry Ford Hospital
Contact: Site Public Contact
Email: [email protected]

Wayne State University/Karmanos Cancer Institute
Contact: Site Public Contact
Email: [email protected]

East China
Henry Ford River District Hospital
Contact: Site Public Contact
Email: [email protected]

Farmington Hills
Weisberg Cancer Treatment Center
Contact: Site Public Contact
Email: [email protected]

Flint
Cancer Hematology Centers - Flint
Contact: Site Public Contact
Email: [email protected]

Genesee Hematology Oncology PC
Contact: Site Public Contact
Email: [email protected]

Genesys Hurley Cancer Institute
Contact: Site Public Contact
Email: [email protected]

Hurley Medical Center
Contact: Site Public Contact
Email: [email protected]

Grand Rapids
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Contact: Site Public Contact
Email: [email protected]

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Contact: Site Public Contact
Email: [email protected]

Trinity Health Grand Rapids Hospital
Contact: Site Public Contact
Email: [email protected]

Grosse Pointe Woods
Henry Ford Saint John Hospital - Academic
Contact: Site Public Contact
Email: [email protected]

Henry Ford Saint John Hospital - Breast
Contact: Site Public Contact
Email: [email protected]

Henry Ford Saint John Hospital - Van Elslander
Contact: Site Public Contact
Email: [email protected]

Jackson
Allegiance Health
Contact: Site Public Contact
Email: [email protected]

Kalamazoo
Beacon Kalamazoo
Contact: Site Public Contact
Email: [email protected]

Bronson Methodist Hospital
Contact: Site Public Contact
Email: [email protected]

West Michigan Cancer Center
Contact: Site Public Contact
Email: [email protected]

Lansing
University of Michigan Health - Sparrow Lansing
Contact: Site Public Contact
Email: [email protected]

Livonia
Hope Cancer Clinic
Contact: Site Public Contact
Email: [email protected]

Trinity Health Saint Mary Mercy Livonia Hospital
Contact: Site Public Contact
Email: [email protected]

Macomb Township
Henry Ford Saint John Hospital - Macomb Medical
Contact: Site Public Contact
Email: [email protected]

Henry Ford Warren Hospital - Breast Macomb
Contact: Site Public Contact
Email: [email protected]

Marlette
Saint Mary's Oncology/Hematology Associates of Marlette
Contact: Site Public Contact
Email: [email protected]

Monroe
Monroe Cancer Center
Contact: Site Public Contact
Email: [email protected]

Muskegon
Trinity Health Muskegon Hospital
Contact: Site Public Contact
Email: [email protected]

Niles
Corewell Health Lakeland Hospitals - Niles Hospital
Contact: Site Public Contact

Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
Contact: Site Public Contact
Email: [email protected]

Novi
Henry Ford Medical Center-Columbus
Contact: Site Public Contact
Email: [email protected]

Pontiac
Hope Cancer Center
Contact: Site Public Contact
Email: [email protected]

Michigan Healthcare Professionals Pontiac
Contact: Site Public Contact
Email: [email protected]

Newland Medical Associates-Pontiac
Contact: Site Public Contact
Email: [email protected]

Trinity Health Saint Joseph Mercy Oakland Hospital
Contact: Site Public Contact
Email: [email protected]

Port Huron
Huron Medical Center PC
Contact: Site Public Contact
Email: [email protected]

Lake Huron Medical Center
Contact: Site Public Contact
Email: [email protected]

Reed City
Corewell Health Reed City Hospital
Contact: Site Public Contact
Email: [email protected]

Rochester Hills
Henry Ford Rochester Hospital
Contact: Site Public Contact
Email: [email protected]

Saginaw
MyMichigan Medical Center Saginaw
Contact: Site Public Contact
Email: [email protected]

Oncology Hematology Associates of Saginaw Valley PC
Contact: Site Public Contact
Email: [email protected]

Saint Joseph
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Contact: Site Public Contact
Email: [email protected]

Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Contact: Site Public Contact
Email: [email protected]

Shelby Township
Henry Ford Macomb Health Center - Shelby Township
Contact: Site Public Contact
Email: [email protected]

Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
Contact: Site Public Contact
Email: [email protected]

Tawas City
MyMichigan Medical Center Tawas
Contact: Site Public Contact
Email: [email protected]

Traverse City
Munson Medical Center
Contact: Site Public Contact
Email: [email protected]

Warren
Advanced Breast Care Center PLLC
Contact: Site Public Contact
Email: [email protected]

Henry Ford Health Warren Hospital
Contact: Site Public Contact
Email: [email protected]

Henry Ford Madison Heights Hospital - Breast
Contact: Site Public Contact
Email: [email protected]

Henry Ford Warren Hospital - GLCMS
Contact: Site Public Contact
Email: [email protected]

Macomb Hematology Oncology PC
Contact: Site Public Contact
Email: [email protected]

West Bloomfield
Henry Ford West Bloomfield Hospital
Contact: Site Public Contact
Email: [email protected]

West Branch
Saint Mary's Oncology/Hematology Associates of West Branch
Contact: Site Public Contact
Email: [email protected]

Wyoming
University of Michigan Health - West
Contact: Site Public Contact
Email: [email protected]

Ypsilanti
Huron Gastroenterology PC
Contact: Site Public Contact
Email: [email protected]

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Contact: Site Public Contact
Email: [email protected]

MN
Bemidji
Sanford Joe Lueken Cancer Center
Contact: Site Public Contact
Email: [email protected]

Burnsville
Fairview Ridges Hospital
Contact: Site Public Contact
Email: [email protected]

Minnesota Oncology - Burnsville
Contact: Site Public Contact
Email: [email protected]

Cambridge
Cambridge Medical Center
Contact: Site Public Contact
Email: [email protected]

Coon Rapids
Mercy Hospital
Contact: Site Public Contact
Email: [email protected]

Edina
Fairview Southdale Hospital
Contact: Site Public Contact
Email: [email protected]

Fridley
Unity Hospital
Contact: Site Public Contact
Email: [email protected]

Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Contact: Site Public Contact
Email: [email protected]

Maplewood
Minnesota Oncology Hematology PA-Maplewood
Contact: Site Public Contact
Email: [email protected]

Saint John's Hospital - Healtheast
Contact: Site Public Contact
Email: [email protected]

Minneapolis
Abbott-Northwestern Hospital
Contact: Site Public Contact
Email: [email protected]

Health Partners Inc
Contact: Site Public Contact
Email: [email protected]

Hennepin County Medical Center
Contact: Site Public Contact
Email: [email protected]

Monticello
Monticello Cancer Center
Contact: Site Public Contact
Email: [email protected]

New Ulm
New Ulm Medical Center
Contact: Site Public Contact
Email: [email protected]

Princeton
Fairview Northland Medical Center
Contact: Site Public Contact
Email: [email protected]

Robbinsdale
North Memorial Medical Health Center
Contact: Site Public Contact
Email: [email protected]

Rochester
Mayo Clinic in Rochester
Contact: Site Public Contact

Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Contact: Site Public Contact
Email: [email protected]

Saint Paul
Regions Hospital
Contact: Site Public Contact
Email: [email protected]

United Hospital
Contact: Site Public Contact
Email: [email protected]

Shakopee
Saint Francis Regional Medical Center
Contact: Site Public Contact
Email: [email protected]

Stillwater
Lakeview Hospital
Contact: Site Public Contact
Email: [email protected]

Thief River Falls
Sanford Thief River Falls Medical Center
Contact: Site Public Contact

Waconia
Ridgeview Medical Center
Contact: Site Public Contact
Email: [email protected]

Willmar
Rice Memorial Hospital
Contact: Site Public Contact
Email: [email protected]

Woodbury
Minnesota Oncology Hematology PA-Woodbury
Contact: Site Public Contact
Email: [email protected]

Worthington
Sanford Cancer Center Worthington
Contact: Site Public Contact

Wyoming
Fairview Lakes Medical Center
Contact: Site Public Contact
Email: [email protected]

MO
Ballwin
Mercy Oncology and Hematology - Clayton-Clarkson
Contact: Site Public Contact

Bolivar
Central Care Cancer Center - Bolivar
Contact: Site Public Contact
Email: [email protected]

Bonne Terre
Parkland Health Center-Bonne Terre
Contact: Site Public Contact

Branson
Cox Cancer Center Branson
Contact: Site Public Contact

Cape Girardeau
Mercy Cancer Center - Cape Girardeau
Contact: Site Public Contact

Saint Francis Medical Center
Contact: Site Public Contact
Email: [email protected]

Creve Coeur
Siteman Cancer Center at West County Hospital
Contact: Site Public Contact
Email: [email protected]

Farmington
Parkland Health Center - Farmington
Contact: Site Public Contact

Independence
Centerpoint Medical Center LLC
Contact: Site Public Contact
Email: [email protected]

Jefferson City
MU Health Care Goldschmidt Cancer Center
Contact: Site Public Contact
Email: [email protected]

Joplin
Freeman Health System
Contact: Site Public Contact
Email: [email protected]

Mercy Hospital Joplin
Contact: Site Public Contact
Email: [email protected]

Kansas City
Research Medical Center
Contact: Site Public Contact
Email: [email protected]

University Health Truman Medical Center
Contact: Site Public Contact

University of Kansas Cancer Center - North
Contact: Site Public Contact
Email: [email protected]

Lee's Summit
University of Kansas Cancer Center - Lee's Summit
Contact: Site Public Contact
Email: [email protected]

Rolla
Mercy Clinic-Rolla-Cancer and Hematology
Contact: Site Public Contact

Phelps Health Delbert Day Cancer Institute
Contact: Site Public Contact
Email: [email protected]

Saint Joseph
Heartland Regional Medical Center
Contact: Site Public Contact
Email: [email protected]

Saint Louis
Mercy Hospital Saint Louis
Contact: Site Public Contact

Mercy Hospital South
Contact: Site Public Contact
Email: [email protected]

Mercy Infusion Center - Chippewa
Contact: Site Public Contact

Missouri Baptist Medical Center
Contact: Site Public Contact

Siteman Cancer Center at Christian Hospital
Contact: Site Public Contact
Email: [email protected]

Siteman Cancer Center-South County
Contact: Site Public Contact
Email: [email protected]

Washington University School of Medicine
Contact: Site Public Contact
Email: [email protected]

Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Contact: Site Public Contact
Email: [email protected]

Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Contact: Site Public Contact

Springfield
CoxHealth South Hospital
Contact: Site Public Contact

Mercy Hospital Springfield
Contact: Site Public Contact

Sullivan
Missouri Baptist Sullivan Hospital
Contact: Site Public Contact

Washington
Mercy Hospital Washington
Contact: Site Public Contact

MT
Anaconda
Community Hospital of Anaconda
Contact: Site Public Contact
Email: [email protected]

Billings
Billings Clinic Cancer Center
Contact: Site Public Contact
Email: [email protected]

Saint Vincent Healthcare
Contact: Site Public Contact
Email: [email protected]

Bozeman
Bozeman Health Deaconess Hospital
Contact: Site Public Contact
Email: [email protected]

Butte
Saint James Community Hospital and Cancer Treatment Center
Contact: Site Public Contact

Great Falls
Benefis Sletten Cancer Institute
Contact: Site Public Contact
Email: [email protected]

Great Falls Clinic
Contact: Site Public Contact
Email: [email protected]

Helena
Saint Peter's Community Hospital
Contact: Site Public Contact
Email: [email protected]

Kalispell
Logan Health Medical Center
Contact: Site Public Contact
Email: [email protected]

Missoula
Community Medical Center
Contact: Site Public Contact
Email: [email protected]

Saint Patrick Hospital - Community Hospital
Contact: Site Public Contact
Email: [email protected]

NC
Asheville
AdventHealth Infusion Center Asheville
Contact: Site Public Contact
Email: [email protected]

Cary
Duke Cancer Center Cary
Contact: Site Public Contact

Clinton
Southeastern Medical Oncology Center-Clinton
Contact: Site Public Contact
Email: [email protected]

Clyde
AdventHealth Infusion Center Haywood
Contact: Site Public Contact
Email: [email protected]

Durham
Duke University Medical Center
Contact: Site Public Contact

Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Contact: Site Public Contact
Email: [email protected]

Wayne Memorial Hospital
Contact: Site Public Contact
Email: [email protected]

Hendersonville
AdventHealth Hendersonville
Contact: Site Public Contact
Email: [email protected]

Jacksonville
Onslow Memorial Hospital
Contact: Site Public Contact
Email: [email protected]

Southeastern Medical Oncology Center-Jacksonville
Contact: Site Public Contact
Email: [email protected]

Raleigh
Duke Cancer Center Raleigh
Contact: Site Public Contact

Washington
Marion L Shepard Cancer Center - ECU Health Beaufort Hospital
Contact: Site Public Contact

ND
Bismarck
Sanford Bismarck Medical Center
Contact: Site Public Contact
Email: [email protected]

Fargo
Sanford Broadway Medical Center
Contact: Site Public Contact
Email: [email protected]

Sanford Roger Maris Cancer Center
Contact: Site Public Contact
Email: [email protected]

Sanford South University Medical Center
Contact: Site Public Contact

NE
Grand Island
Nebraska Cancer Specialists/Oncology Hematology West PC
Contact: Site Public Contact
Email: [email protected]

Kearney
CHI Health Good Samaritan
Contact: Site Public Contact
Email: [email protected]

Fred and Pamela Buffett Cancer Center - Kearney
Contact: Site Public Contact
Email: [email protected]

Lincoln
Saint Elizabeth Regional Medical Center
Contact: Site Public Contact
Email: [email protected]

Omaha
Alegent Health Bergan Mercy Medical Center
Contact: Site Public Contact
Email: [email protected]

Alegent Health Immanuel Medical Center
Contact: Site Public Contact
Email: [email protected]

Alegent Health Lakeside Hospital
Contact: Site Public Contact
Email: [email protected]

Hematology and Oncology Consultants PC
Contact: Site Public Contact
Email: [email protected]

Papillion
Midlands Community Hospital
Contact: Site Public Contact
Email: [email protected]

NH
Lebanon
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Contact: Site Public Contact
Email: [email protected]

NJ
Mullica Hill
Inspira Medical Center Mullica Hill
Contact: Site Public Contact
Email: [email protected]

Vineland
Inspira Medical Center Vineland
Contact: Site Public Contact

NM
Albuquerque
University of New Mexico Cancer Center
Contact: Site Public Contact
Email: [email protected]

NV
Carson City
Carson Tahoe Regional Medical Center
Contact: Site Public Contact
Email: [email protected]

Henderson
Cancer and Blood Specialists-Henderson
Contact: Site Public Contact
Email: [email protected]

Comprehensive Cancer Centers of Nevada - Henderson
Contact: Site Public Contact
Email: [email protected]

Comprehensive Cancer Centers of Nevada-Horizon Ridge
Contact: Site Public Contact
Email: [email protected]

Comprehensive Cancer Centers of Nevada-Southeast Henderson
Contact: Site Public Contact
Email: [email protected]

Las Vegas Cancer Center-Henderson
Contact: Site Public Contact
Email: [email protected]

Las Vegas Urology - Green Valley
Contact: Site Public Contact
Email: [email protected]

Las Vegas Urology - Pebble
Contact: Site Public Contact
Email: [email protected]

Oncology Las Vegas - Henderson
Contact: Site Public Contact
Email: [email protected]

Urology Specialists of Nevada - Green Valley
Contact: Site Public Contact
Email: [email protected]

Las Vegas
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Contact: Site Public Contact
Email: [email protected]

Ann M Wierman MD LTD
Contact: Site Public Contact
Email: [email protected]

Cancer Therapy and Integrative Medicine
Contact: Site Public Contact
Email: [email protected]

Cancer and Blood Specialists-Shadow
Contact: Site Public Contact
Email: [email protected]

Cancer and Blood Specialists-Tenaya
Contact: Site Public Contact
Email: [email protected]

Comprehensive Cancer Centers of Nevada
Contact: Site Public Contact
Email: [email protected]

Comprehensive Cancer Centers of Nevada - Central Valley
Contact: Site Public Contact
Email: [email protected]

Comprehensive Cancer Centers of Nevada - Northwest
Contact: Site Public Contact
Email: [email protected]

Comprehensive Cancer Centers of Nevada - Town Center
Contact: Site Public Contact
Email: [email protected]

Comprehensive Cancer Centers of Nevada-Summerlin
Contact: Site Public Contact
Email: [email protected]

Desert West Surgery
Contact: Site Public Contact
Email: [email protected]

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Contact: Site Public Contact
Email: [email protected]

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Contact: Site Public Contact
Email: [email protected]

HealthCare Partners Medical Group Oncology/Hematology-San Martin
Contact: Site Public Contact
Email: [email protected]

HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Contact: Site Public Contact
Email: [email protected]

Hope Cancer Care of Nevada
Contact: Site Public Contact
Email: [email protected]

Las Vegas Cancer Center-Medical Center
Contact: Site Public Contact
Email: [email protected]

Las Vegas Prostate Cancer Center
Contact: Site Public Contact
Email: [email protected]

Las Vegas Urology - Cathedral Rock
Contact: Site Public Contact
Email: [email protected]

Las Vegas Urology - Pecos
Contact: Site Public Contact
Email: [email protected]

Las Vegas Urology - Smoke Ranch
Contact: Site Public Contact
Email: [email protected]

Las Vegas Urology - Sunset
Contact: Site Public Contact
Email: [email protected]

Oncology Las Vegas - Tenaya
Contact: Site Public Contact
Email: [email protected]

OptumCare Cancer Care at Charleston
Contact: Site Public Contact
Email: [email protected]

OptumCare Cancer Care at Fort Apache
Contact: Site Public Contact
Email: [email protected]

OptumCare Cancer Care at MountainView
Contact: Site Public Contact
Email: [email protected]

Radiation Oncology Centers of Nevada Central
Contact: Site Public Contact
Email: [email protected]

Radiation Oncology Centers of Nevada Southeast
Contact: Site Public Contact
Email: [email protected]

Summerlin Hospital Medical Center
Contact: Site Public Contact
Email: [email protected]

Sunrise Hospital and Medical Center
Contact: Site Public Contact
Email: [email protected]

University Cancer Center
Contact: Site Public Contact
Email: [email protected]

University Medical Center of Southern Nevada
Contact: Site Public Contact
Email: [email protected]

Urology Specialists of Nevada - Central
Contact: Site Public Contact
Email: [email protected]

Urology Specialists of Nevada - Northwest
Contact: Site Public Contact
Email: [email protected]

Urology Specialists of Nevada - Southwest
Contact: Site Public Contact
Email: [email protected]

Pahrump
Hope Cancer Care of Nevada-Pahrump
Contact: Site Public Contact
Email: [email protected]

Reno
Radiation Oncology Associates
Contact: Site Public Contact
Email: [email protected]

Renown Regional Medical Center
Contact: Site Public Contact
Email: [email protected]

Saint Mary's Regional Medical Center
Contact: Site Public Contact
Email: [email protected]

NY
Bronx
Montefiore Medical Center - Moses Campus
Contact: Site Public Contact
Email: [email protected]

Montefiore Medical Center-Einstein Campus
Contact: Site Public Contact
Email: [email protected]

Montefiore Medical Center-Weiler Hospital
Contact: Site Public Contact
Email: [email protected]

New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Contact: Site Public Contact
Email: [email protected]

OH
Beachwood
UHHS-Chagrin Highlands Medical Center
Contact: Site Public Contact
Email: [email protected]

Beavercreek
Indu and Raj Soin Medical Center
Contact: Site Public Contact
Email: [email protected]

Belpre
Strecker Cancer Center-Belpre
Contact: Site Public Contact
Email: [email protected]

Boardman
Saint Elizabeth Boardman Hospital
Contact: Site Public Contact
Email: [email protected]

Centerville
Dayton Physicians LLC-Miami Valley South
Contact: Site Public Contact
Email: [email protected]

Miami Valley Hospital South
Contact: Site Public Contact
Email: [email protected]

Chardon
Geauga Hospital
Contact: Site Public Contact
Email: [email protected]

Chillicothe
Adena Regional Medical Center
Contact: Site Public Contact
Email: [email protected]

Cincinnati
Bethesda North Hospital
Contact: Site Public Contact
Email: [email protected]

Good Samaritan Hospital - Cincinnati
Contact: Site Public Contact
Email: [email protected]

Oncology Hematology Care Inc-Anderson
Contact: Site Public Contact
Email: [email protected]

Oncology Hematology Care Inc-Blue Ash
Contact: Site Public Contact
Email: [email protected]

Oncology Hematology Care Inc-Eden Park
Contact: Site Public Contact
Email: [email protected]

Oncology Hematology Care Inc-Kenwood
Contact: Site Public Contact
Email: [email protected]

Oncology Hematology Care Inc-Mercy West
Contact: Site Public Contact
Email: [email protected]

TriHealth Cancer Institute-Anderson
Contact: Site Public Contact
Email: [email protected]

TriHealth Cancer Institute-Westside
Contact: Site Public Contact
Email: [email protected]

University of Cincinnati Cancer Center-UC Medical Center
Contact: Site Public Contact
Email: [email protected]

Cleveland
Case Western Reserve University
Contact: Site Public Contact
Email: [email protected]

Cleveland Clinic Cancer Center/Fairview Hospital
Contact: Site Public Contact
Email: [email protected]

Cleveland Clinic Foundation
Contact: Site Public Contact
Email: [email protected]

MetroHealth Medical Center
Contact: Site Public Contact
Email: [email protected]

Columbus
Columbus Oncology and Hematology Associates Inc
Contact: Site Public Contact
Email: [email protected]

Doctors Hospital
Contact: Site Public Contact
Email: [email protected]

Grant Medical Center
Contact: Site Public Contact
Email: [email protected]

Mount Carmel East Hospital
Contact: Site Public Contact
Email: [email protected]

Mount Carmel Health Center West
Contact: Site Public Contact
Email: [email protected]

Ohio State University Comprehensive Cancer Center
Contact: Site Public Contact
Email: [email protected]

Riverside Methodist Hospital
Contact: Site Public Contact
Email: [email protected]

The Mark H Zangmeister Center
Contact: Site Public Contact
Email: [email protected]

Dayton
Dayton Physician LLC - Englewood
Contact: Site Public Contact
Email: [email protected]

Good Samaritan Hospital - Dayton
Contact: Site Public Contact
Email: [email protected]

Miami Valley Hospital
Contact: Site Public Contact
Email: [email protected]

Miami Valley Hospital North
Contact: Site Public Contact
Email: [email protected]

Delaware
Delaware Health Center-Grady Cancer Center
Contact: Site Public Contact
Email: [email protected]

Delaware Radiation Oncology
Contact: Site Public Contact
Email: [email protected]

Grady Memorial Hospital
Contact: Site Public Contact
Email: [email protected]

Dublin
Dublin Methodist Hospital
Contact: Site Public Contact
Email: [email protected]

Elyria
Mercy Cancer Center-Elyria
Contact: Site Public Contact
Email: [email protected]

Fairfield
Oncology Hematology Care Inc-Healthplex
Contact: Site Public Contact
Email: [email protected]

Findlay
Armes Family Cancer Center
Contact: Site Public Contact
Email: [email protected]

Blanchard Valley Hospital
Contact: Site Public Contact
Email: [email protected]

Orion Cancer Care
Contact: Site Public Contact
Email: [email protected]

Franklin
Atrium Medical Center-Middletown Regional Hospital
Contact: Site Public Contact
Email: [email protected]

Dayton Physicians LLC-Atrium
Contact: Site Public Contact
Email: [email protected]

Greenville
Dayton Physicians LLC-Wayne
Contact: Site Public Contact
Email: [email protected]

Wayne Hospital
Contact: Site Public Contact
Email: [email protected]

Grove City
Mount Carmel Grove City Hospital
Contact: Site Public Contact
Email: [email protected]

Independence
Cleveland Clinic Cancer Center Independence
Contact: Site Public Contact
Email: [email protected]

Kettering
First Dayton Cancer Care
Contact: Site Public Contact
Email: [email protected]

Greater Dayton Cancer Center
Contact: Site Public Contact
Email: [email protected]

Kettering Medical Center
Contact: Site Public Contact
Email: [email protected]

Lancaster
Fairfield Medical Center
Contact: Site Public Contact
Email: [email protected]

Mansfield
OhioHealth Mansfield Hospital
Contact: Site Public Contact
Email: [email protected]

Marietta
Marietta Memorial Hospital
Contact: Site Public Contact
Email: [email protected]

Marion
OhioHealth Marion General Hospital
Contact: Site Public Contact
Email: [email protected]

Mayfield Heights
Hillcrest Hospital Cancer Center
Contact: Site Public Contact
Email: [email protected]

UH Seidman Cancer Center at Landerbrook Health Center
Contact: Site Public Contact
Email: [email protected]

Mentor
UH Seidman Cancer Center at Lake Health Mentor Campus
Contact: Site Public Contact
Email: [email protected]

Middleburg Heights
UH Seidman Cancer Center at Southwest General Hospital
Contact: Site Public Contact
Email: [email protected]

Middletown
Dayton Physicians LLC-Signal Point
Contact: Site Public Contact
Email: [email protected]

Mount Vernon
Knox Community Hospital
Contact: Site Public Contact
Email: [email protected]

Newark
Licking Memorial Hospital
Contact: Site Public Contact
Email: [email protected]

Newark Radiation Oncology
Contact: Site Public Contact
Email: [email protected]

Parma
University Hospitals Parma Medical Center
Contact: Site Public Contact
Email: [email protected]

Portsmouth
Southern Ohio Medical Center
Contact: Site Public Contact
Email: [email protected]

Sandusky
North Coast Cancer Care
Contact: Site Public Contact
Email: [email protected]

UH Seidman Cancer Center at Firelands Regional Medical Center
Contact: Site Public Contact
Email: [email protected]

Sidney
Dayton Physicians LLC-Wilson
Contact: Site Public Contact
Email: [email protected]

Springfield
Springfield Regional Cancer Center
Contact: Site Public Contact
Email: [email protected]

Springfield Regional Medical Center
Contact: Site Public Contact
Email: [email protected]

Strongsville
Cleveland Clinic Cancer Center Strongsville
Contact: Site Public Contact
Email: [email protected]

Sylvania
ProMedica Flower Hospital
Contact: Site Public Contact

Toledo
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Contact: Site Public Contact

Troy
Dayton Physicians LLC - Troy
Contact: Site Public Contact
Email: [email protected]

Upper Valley Medical Center
Contact: Site Public Contact
Email: [email protected]

Wadsworth
University Hospitals Sharon Health Center
Contact: Site Public Contact
Email: [email protected]

Warren
Saint Joseph Warren Hospital
Contact: Site Public Contact
Email: [email protected]

Warrensville Heights
South Pointe Hospital
Contact: Site Public Contact
Email: [email protected]

West Chester
University of Cincinnati Cancer Center-West Chester
Contact: Site Public Contact
Email: [email protected]

Westerville
Saint Ann's Hospital
Contact: Site Public Contact
Email: [email protected]

Westlake
UH Seidman Cancer Center at Saint John Medical Center
Contact: Site Public Contact
Email: [email protected]

UHHS-Westlake Medical Center
Contact: Site Public Contact
Email: [email protected]

Wooster
Cleveland Clinic Wooster Family Health and Surgery Center
Contact: Site Public Contact
Email: [email protected]

Youngstown
Saint Elizabeth Youngstown Hospital
Contact: Site Public Contact
Email: [email protected]

Zanesville
Genesis Healthcare System Cancer Care Center
Contact: Site Public Contact
Email: [email protected]

OK
Lawton
Cancer Centers of Southwest Oklahoma Research
Contact: Site Public Contact

Oklahoma City
Mercy Hospital Oklahoma City
Contact: Site Public Contact

University of Oklahoma Health Sciences Center
Contact: Site Public Contact
Email: [email protected]

OR
Baker City
Saint Alphonsus Cancer Care Center-Baker City
Contact: Site Public Contact
Email: [email protected]

Ontario
Saint Alphonsus Cancer Care Center-Ontario
Contact: Site Public Contact
Email: [email protected]

PA
Allentown
Lehigh Valley Hospital-Cedar Crest
Contact: Site Public Contact
Email: [email protected]

Beaver
UPMC-Heritage Valley Health System Beaver
Contact: Site Public Contact

Bethlehem
Lehigh Valley Hospital - Muhlenberg
Contact: Site Public Contact
Email: [email protected]

Chadds Ford
Christiana Care Health System-Concord Health Center
Contact: Site Public Contact
Email: [email protected]

Danville
Geisinger Medical Center
Contact: Site Public Contact
Email: [email protected]

East Stroudsburg
Pocono Medical Center
Contact: Site Public Contact
Email: [email protected]

Greensburg
UPMC Cancer Centers - Arnold Palmer Pavilion
Contact: Site Public Contact

Hazleton
Geisinger Medical Center-Cancer Center Hazleton
Contact: Site Public Contact
Email: [email protected]

Lehigh Valley Hospital-Hazleton
Contact: Site Public Contact
Email: [email protected]

Hershey
Penn State Milton S Hershey Medical Center
Contact: Site Public Contact
Email: [email protected]

Johnstown
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Contact: Site Public Contact

Lewisburg
Geisinger Medical Oncology-Lewisburg
Contact: Site Public Contact
Email: [email protected]

Lewistown
Lewistown Hospital
Contact: Site Public Contact
Email: [email protected]

McKeesport
UPMC Cancer Center at UPMC McKeesport
Contact: Site Public Contact

Moon Township
UPMC Hillman Cancer Center in Coraopolis
Contact: Site Public Contact

Philadelphia
Fox Chase Cancer Center
Contact: Site Public Contact

University of Pennsylvania/Abramson Cancer Center
Contact: Site Public Contact

Pittsburgh
UPMC Hillman Cancer Center
Contact: Site Public Contact

UPMC Jefferson Regional Radiation Oncology
Contact: Site Public Contact

UPMC-Magee Womens Hospital
Contact: Site Public Contact

UPMC-Passavant Hospital
Contact: Site Public Contact

UPMC-Presbyterian Hospital
Contact: Site Public Contact

UPMC-Saint Clair Hospital Cancer Center
Contact: Site Public Contact

UPMC-Saint Margaret
Contact: Site Public Contact

UPMC-Shadyside Hospital
Contact: Site Public Contact

Pottsville
Geisinger Cancer Services-Pottsville
Contact: Site Public Contact
Email: [email protected]

Scranton
Community Medical Center
Contact: Site Public Contact
Email: [email protected]

Selinsgrove
Geisinger Medical Oncology-Selinsgrove
Contact: Site Public Contact
Email: [email protected]

Seneca
UPMC Cancer Center at UPMC Northwest
Contact: Site Public Contact

State College
Geisinger Medical Group
Contact: Site Public Contact
Email: [email protected]

Uniontown
UPMC Uniontown Hospital Radiation Oncology
Contact: Site Public Contact

Washington
UPMC Washington Hospital Radiation Oncology
Contact: Site Public Contact
Email: [email protected]

Wilkes-Barre
Geisinger Wyoming Valley/Henry Cancer Center
Contact: Site Public Contact
Email: [email protected]

SC
Anderson
AnMed Health Cancer Center
Contact: Site Public Contact
Email: [email protected]

Boiling Springs
Prisma Health Cancer Institute - Spartanburg
Contact: Site Public Contact
Email: [email protected]

Charleston
Medical University of South Carolina
Contact: Site Public Contact
Email: [email protected]

Easley
Prisma Health Cancer Institute - Easley
Contact: Site Public Contact
Email: [email protected]

Greenville
Prisma Health Cancer Institute - Butternut
Contact: Site Public Contact
Email: [email protected]

Prisma Health Cancer Institute - Eastside
Contact: Site Public Contact
Email: [email protected]

Prisma Health Cancer Institute - Faris
Contact: Site Public Contact
Email: [email protected]

Prisma Health Greenville Memorial Hospital
Contact: Site Public Contact
Email: [email protected]

Greer
Prisma Health Cancer Institute - Greer
Contact: Site Public Contact
Email: [email protected]

Seneca
Prisma Health Cancer Institute - Seneca
Contact: Site Public Contact
Email: [email protected]

SD
Sioux Falls
Sanford Cancer Center Oncology Clinic
Contact: Site Public Contact
Email: [email protected]

Sanford USD Medical Center - Sioux Falls
Contact: Site Public Contact
Email: [email protected]

TN
Chattanooga
Memorial Hospital
Contact: Site Public Contact
Email: [email protected]

Hixson
Pulmonary Medicine Center of Chattanooga-Hixson
Contact: Site Public Contact
Email: [email protected]

Ooltewah
Memorial GYN Plus
Contact: Site Public Contact
Email: [email protected]

TX
Bryan
Saint Joseph Regional Cancer Center
Contact: Site Public Contact
Email: [email protected]

Dallas
Parkland Memorial Hospital
Contact: Site Public Contact
Email: [email protected]

UT Southwestern/Simmons Cancer Center-Dallas
Contact: Site Public Contact
Email: [email protected]

Fort Worth
UT Southwestern/Simmons Cancer Center-Fort Worth
Contact: Site Public Contact
Email: [email protected]

Houston
Houston Methodist Hospital
Contact: Site Public Contact

Methodist Willowbrook Hospital
Contact: Site Public Contact
Email: [email protected]

Richardson
UT Southwestern Clinical Center at Richardson/Plano
Contact: Site Public Contact
Email: [email protected]

San Antonio
University of Texas Health Science Center at San Antonio
Contact: Site Public Contact
Email: [email protected]

Sugar Land
Houston Methodist Sugar Land Hospital
Contact: Site Public Contact

UT
Farmington
Farmington Health Center
Contact: Site Public Contact
Email: [email protected]

Salt Lake City
Huntsman Cancer Institute/University of Utah
Contact: Site Public Contact
Email: [email protected]

University of Utah Sugarhouse Health Center
Contact: Site Public Contact
Email: [email protected]

WI
Burlington
Aurora Cancer Care-Southern Lakes VLCC
Contact: Site Public Contact
Email: [email protected]

Chippewa Falls
Marshfield Clinic-Chippewa Center
Contact: Site Public Contact
Email: [email protected]

Eau Claire
Marshfield Clinic Cancer Center at Sacred Heart
Contact: Site Public Contact
Email: [email protected]

Marshfield Medical Center-EC Cancer Center
Contact: Site Public Contact
Email: [email protected]

Fond Du Lac
Aurora Health Center-Fond du Lac
Contact: Site Public Contact
Email: [email protected]

Germantown
Aurora Health Care Germantown Health Center
Contact: Site Public Contact
Email: [email protected]

Grafton
Aurora Cancer Care-Grafton
Contact: Site Public Contact
Email: [email protected]

Green Bay
Aurora BayCare Medical Center
Contact: Site Public Contact
Email: [email protected]

Johnson Creek
University of Wisconsin Carbone Cancer Center - Johnson Creek
Contact: Site Public Contact
Email: [email protected]

Kenosha
Aurora Cancer Care-Kenosha South
Contact: Site Public Contact
Email: [email protected]

Ladysmith
Marshfield Medical Center - Ladysmith
Contact: Site Public Contact
Email: [email protected]

Madison
University of Wisconsin Carbone Cancer Center - University Hospital
Contact: Site Public Contact

Marinette
Aurora Bay Area Medical Group-Marinette
Contact: Site Public Contact
Email: [email protected]

Bay Area Medical Center
Contact: Site Public Contact
Email: [email protected]

Marshfield
Marshfield Medical Center-Marshfield
Contact: Site Public Contact
Email: [email protected]

Milwaukee
Aurora Cancer Care-Milwaukee
Contact: Site Public Contact
Email: [email protected]

Aurora Saint Luke's Medical Center
Contact: Site Public Contact
Email: [email protected]

Aurora Sinai Medical Center
Contact: Site Public Contact
Email: [email protected]

Medical College of Wisconsin
Contact: Site Public Contact

Minocqua
Marshfield Medical Center - Minocqua
Contact: Site Public Contact
Email: [email protected]

New Richmond
Cancer Center of Western Wisconsin
Contact: Site Public Contact
Email: [email protected]

Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Contact: Site Public Contact
Email: [email protected]

Racine
Aurora Cancer Care-Racine
Contact: Site Public Contact
Email: [email protected]

Rice Lake
Marshfield Medical Center-Rice Lake
Contact: Site Public Contact
Email: [email protected]

Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Contact: Site Public Contact
Email: [email protected]

Stevens Point
Aspirus Cancer Care - Stevens Point
Contact: Site Public Contact
Email: [email protected]

Marshfield Medical Center-River Region at Stevens Point
Contact: Site Public Contact
Email: [email protected]

Summit
Aurora Medical Center in Summit
Contact: Site Public Contact
Email: [email protected]

Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Contact: Site Public Contact
Email: [email protected]

Waukesha
Aurora Cancer Care-Waukesha
Contact: Site Public Contact
Email: [email protected]

Wausau
Marshfield Clinic-Wausau Center
Contact: Site Public Contact
Email: [email protected]

Wauwatosa
Aurora Cancer Care-Milwaukee West
Contact: Site Public Contact
Email: [email protected]

West Allis
Aurora West Allis Medical Center
Contact: Site Public Contact
Email: [email protected]

Weston
Marshfield Medical Center - Weston
Contact: Site Public Contact
Email: [email protected]

Wisconsin Rapids
Marshfield Clinic - Wisconsin Rapids Center
Contact: Site Public Contact
Email: [email protected]

WY
Cody
Big Horn Basin Cancer Center
Contact: Site Public Contact
Email: [email protected]

Billings Clinic-Cody
Contact: Site Public Contact
Email: [email protected]

Sheridan
Welch Cancer Center
Contact: Site Public Contact
Email: [email protected]

PRIMARY OBJECTIVE:
I. To assess the progression free survival (PFS) of platinum (cisplatin or carboplatin) and etoposide versus the PFS of temozolomide and capecitabine in patients with advanced G3 non-small cell gastroenteropancreatic neuroendocrine carcinomas.

SECONDARY OBJECTIVES:
I. To assess the response rate (RR) of platinum (cisplatin or carboplatin) and etoposide versus the RR of temozolomide and capecitabine in patients with advanced G3 non-small cell gastroenteropancreatic neuroendocrine carcinomas.
II. To assess the overall survival (OS) of platinum (cisplatin or carboplatin) and etoposide versus the OS of temozolomide and capecitabine in patients with advanced G3 non-small cell gastroenteropancreatic neuroendocrine carcinomas.
III. To evaluate the toxicities associated with the combination of temozolomide and capecitabine and the combination of platinum (cisplatin or carboplatin) and etoposide, respectively, in patients with advanced G3 non-small cell gastroenteropancreatic neuroendocrine carcinomas.

LABORATORY RESEARCH OBJECTIVES:
I. To assess the impact of each treatment regimen on PFS, RR and OS based on marker Ki-67 index in patients with advanced G3 non-small cell gastroenteropancreatic neuroendocrine carcinomas.
II. To assess the prognostic significance of well differentiated versus poorly differentiated non-small cell gastroenteropancreatic neuroendocrine tumors in relationship to survival and response to treatment.
III. To assess the agreement in Ki-67 status between that reported by institutional pathologist and that reported by central pathology review.

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

ARM A: Patients receive capecitabine orally (PO) twice daily (BID) on days 1-14 and temozolomide PO once daily (QD) on days 10-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive cisplatin intravenously (IV) on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, then every 3 months for 2 years and then every 6 months for 3 years.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed and conducted this trial with funding from the National Cancer Institute through its National Clinical Trials Network.