Erlotinib and Gemcitabine With or Without Panitumumab in Treating Patients With Metastatic Pancreatic Cancer
21 februari 2017 bijgewerkt door: Alliance for Clinical Trials in Oncology
Randomized Phase II Trial of Panitumumab, Erlotinib and Gemcitabine vs. Erlotinib and Gemcitabine in Patients With Untreated, Metastatic Pancreatic Adenocarcinoma
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Panitumumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor.
PURPOSE: This randomized phase II trial is studying how well giving panitumumab together with gemcitabine and erlotinib works compared to giving gemcitabine and erlotinib alone in treating patients with metastatic pancreatic cancer.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
OBJECTIVES:
Primary
- To assess whether the addition of panitumumab (a dual-epidermal growth factor receptor inhibitor) to standard chemotherapy comprising gemcitabine hydrochloride and erlotinib hydrochloride results in an improvement in overall survival of patients with previously untreated, metastatic adenocarcinoma of the pancreas.
Secondary
- To compare objective response rates, progression-free survival, time to treatment failure, quality of life, and adverse event rates in patients treated with these regimens.
- To evaluate the downstream marker, KRAS, in stool specimens.
OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance status (0 vs 1) and prior adjuvant chemotherapy (yes vs no). The first 6 patients are assigned to arm II. Subsequent patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above in the absence of disease progression or unacceptable toxicity. Patients achieving a CR after 4 courses of treatment receive maintenance therapy comprising erlotinib hydrochloride daily until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression (using the first progression tumor measurements as the new baseline reference).
- Arm II: Patients receive gemcitabine hydrochloride and erlotinib hydrochloride as in arm I and panitumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above in the absence of disease progression or unacceptable toxicity. Patients achieving a CR after 4 courses of treatment receive maintenance therapy comprising erlotinib hydrochloride daily and panitumumab every 2 weeks until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression (using the first progression tumor measurements as the new baseline reference).
Stool samples are collected at baseline and analyzed for KRAS mutations via protein analyses.
Quality of life will be assessed at baseline, every 2 courses during treatment, and at the end of treatment.
After the second progression, patients are followed every 3-6 months for 2 years.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
104
Fase
- Fase 2
Contacten en locaties
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Studie Locaties
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Colorado
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Aurora, Colorado, Verenigde Staten, 80012
- Aurora Presbyterian Hospital
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Boulder, Colorado, Verenigde Staten, 80301-9019
- Boulder Community Hospital
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Colorado Springs, Colorado, Verenigde Staten, 80933
- Penrose Cancer Center at Penrose Hospital
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Denver, Colorado, Verenigde Staten, 80210
- Porter Adventist Hospital
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Denver, Colorado, Verenigde Staten, 80220
- Rose Medical Center
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Denver, Colorado, Verenigde Staten, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Verenigde Staten, 80204
- St. Anthony Central Hospital
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Denver, Colorado, Verenigde Staten, 80218
- St. Joseph Hospital
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Denver, Colorado, Verenigde Staten, 80224-2522
- CCOP - Colorado Cancer Research Program
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Englewood, Colorado, Verenigde Staten, 80110
- Swedish Medical Center
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Fort Collins, Colorado, Verenigde Staten, 80528
- Front Range Cancer Specialists
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Grand Junction, Colorado, Verenigde Staten, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
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Greeley, Colorado, Verenigde Staten, 80631
- North Colorado Medical Center
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Lone Tree, Colorado, Verenigde Staten, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Verenigde Staten, 80501
- Hope Cancer Care Center at Longmont United Hospital
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Loveland, Colorado, Verenigde Staten, 80539
- McKee Medical Center
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Thornton, Colorado, Verenigde Staten, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, Verenigde Staten, 80033
- Exempla Lutheran Medical Center
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Connecticut
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Hartford, Connecticut, Verenigde Staten, 06105
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
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Florida
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Jacksonville, Florida, Verenigde Staten, 32224
- Mayo Clinic - Jacksonville
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Hawaii
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Aiea, Hawaii, Verenigde Staten, 96701
- Kapiolani Medical Center at Pali Momi
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Honolulu, Hawaii, Verenigde Staten, 96813
- Cancer Research Center of Hawaii
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Honolulu, Hawaii, Verenigde Staten, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, Verenigde Staten, 96813
- OnCare Hawaii, Incorporated - Lusitana
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Honolulu, Hawaii, Verenigde Staten, 96813
- Queen's Cancer Institute at Queen's Medical Center
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Honolulu, Hawaii, Verenigde Staten, 96813
- Straub Clinic and Hospital, Incorporated
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Honolulu, Hawaii, Verenigde Staten, 96817
- Hawaii Medical Center - East
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Honolulu, Hawaii, Verenigde Staten, 96817
- OnCare Hawaii, Incorporated - Kuakini
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Wailuku, Hawaii, Verenigde Staten, 96793
- Pacific Cancer Institute - Maui
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Illinois
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Bloomington, Illinois, Verenigde Staten, 61701
- St. Joseph Medical Center
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Bloomington%, Illinois, Verenigde Staten, 61701
- Illinois CancerCare - Bloomington
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Canton, Illinois, Verenigde Staten, 61520
- Illinois CancerCare - Canton
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Canton, Illinois, Verenigde Staten, 61520
- Graham Hospital
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Carthage, Illinois, Verenigde Staten, 62321
- Memorial Hospital
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Carthage, Illinois, Verenigde Staten, 62321
- Illinois CancerCare - Carthage
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Eureka, Illinois, Verenigde Staten, 61530
- Illinois CancerCare - Eureka
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Eureka, Illinois, Verenigde Staten, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Verenigde Staten, 61401
- Illinois CancerCare - Galesburg
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Galesburg, Illinois, Verenigde Staten, 61401
- Galesburg Clinic, PC
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Havana, Illinois, Verenigde Staten, 62644
- Mason District Hospital
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Havana, Illinois, Verenigde Staten, 62644
- Illinois CancerCare - Havana
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Kewanee, Illinois, Verenigde Staten, 61443
- Illinois CancerCare - Kewanee Clinic
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Macomb, Illinois, Verenigde Staten, 61455
- Illinois CancerCare - Macomb
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Macomb, Illinois, Verenigde Staten, 61455
- Mcdonough District Hospital
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Moline, Illinois, Verenigde Staten, 61265
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Moline, Illinois, Verenigde Staten, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Monmouth, Illinois, Verenigde Staten, 61462
- Illinois CancerCare - Monmouth
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Normal, Illinois, Verenigde Staten, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Verenigde Staten, 61761
- Community Cancer Center
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Normal, Illinois, Verenigde Staten, 61761
- Illinois CancerCare - Community Cancer Center
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Ottawa, Illinois, Verenigde Staten, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Verenigde Staten, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Verenigde Staten, 61554
- Cancer Treatment Center at Pekin Hospital
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Pekin, Illinois, Verenigde Staten, 61603
- Illinois CancerCare - Pekin
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Peoria, Illinois, Verenigde Staten, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Verenigde Staten, 61614
- Proctor Hospital
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Peoria, Illinois, Verenigde Staten, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Verenigde Staten, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Verenigde Staten, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Verenigde Staten, 61354
- Illinois CancerCare - Peru
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Peru, Illinois, Verenigde Staten, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Verenigde Staten, 61356
- Perry Memorial Hospital
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Princeton, Illinois, Verenigde Staten, 61356
- Illinois CancerCare - Princeton
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Spring Valley, Illinois, Verenigde Staten, 61362
- Illinois CancerCare - Spring Valley
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Indiana
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Beech Grove, Indiana, Verenigde Staten, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Elkhart, Indiana, Verenigde Staten, 46515
- Elkhart General Hospital
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Elkhart, Indiana, Verenigde Staten, 46514-2098
- Elkhart Clinic, LLC
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Kokomo, Indiana, Verenigde Staten, 46904
- Howard Community Hospital
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La Porte, Indiana, Verenigde Staten, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Richmond, Indiana, Verenigde Staten, 47374
- Reid Hospital & Health Care Services
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South Bend, Indiana, Verenigde Staten, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Verenigde Staten, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, Verenigde Staten, 46617
- Saint Joseph Regional Medical Center
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South Bend, Indiana, Verenigde Staten, 46617
- South Bend Clinic
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South Bend, Indiana, Verenigde Staten, 46601
- Michiana Hematology-Oncology, PC - South Bend
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Iowa
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Ames, Iowa, Verenigde Staten, 50010
- McFarland Clinic, PC
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Bettendorf, Iowa, Verenigde Staten, 52722
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Cedar Rapids, Iowa, Verenigde Staten, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, Verenigde Staten, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Clive, Iowa, Verenigde Staten, 50325
- Medical Oncology and Hematology Associates - West Des Moines
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Des Moines, Iowa, Verenigde Staten, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Verenigde Staten, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Verenigde Staten, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Verenigde Staten, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Verenigde Staten, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Verenigde Staten, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Des Moines, Iowa, Verenigde Staten, 50307
- Mercy Capitol Hospital
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Sioux City, Iowa, Verenigde Staten, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Verenigde Staten, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Verenigde Staten, 51104
- Mercy Medical Center - Sioux City
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Kansas
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Chanute, Kansas, Verenigde Staten, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Verenigde Staten, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Verenigde Staten, 67042
- Cancer Center of Kansas, PA - El Dorado
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Fort Scott, Kansas, Verenigde Staten, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Verenigde Staten, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Verenigde Staten, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, Verenigde Staten, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Verenigde Staten, 67905
- Cancer Center of Kansas, PA - Liberal
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Newton, Kansas, Verenigde Staten, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Verenigde Staten, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Verenigde Staten, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Verenigde Staten, 67401
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, Verenigde Staten, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Verenigde Staten, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Verenigde Staten, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Verenigde Staten, 67214
- CCOP - Wichita
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Wichita, Kansas, Verenigde Staten, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Verenigde Staten, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, Verenigde Staten, 67156
- Cancer Center of Kansas, PA - Winfield
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Louisiana
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Baton Rouge, Louisiana, Verenigde Staten, 70809
- Ochsner Health Center - Bluebonnet
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Covington, Louisiana, Verenigde Staten, 70433
- Ochsner Health Center - Covington
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New Orleans, Louisiana, Verenigde Staten, 70121
- CCOP - Ochsner
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New Orleans, Louisiana, Verenigde Staten, 70121
- Ochsner Cancer Institute at Ochsner Clinic Foundation
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Michigan
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Adrian, Michigan, Verenigde Staten, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, Verenigde Staten, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Verenigde Staten, 48106
- CCOP - Michigan Cancer Research Consortium
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Dearborn, Michigan, Verenigde Staten, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Escanaba, Michigan, Verenigde Staten, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, Verenigde Staten, 48503
- Hurley Medical Center
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Flint, Michigan, Verenigde Staten, 48503
- Genesys Hurley Cancer Institute
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Grosse Pointe Woods, Michigan, Verenigde Staten, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Iron Mountain, Michigan, Verenigde Staten, 49801
- Dickinson County Healthcare System
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Jackson, Michigan, Verenigde Staten, 49201
- Foote Memorial Hospital
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Lambertville, Michigan, Verenigde Staten, 48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
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Lansing, Michigan, Verenigde Staten, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, Verenigde Staten, 48154
- St. Mary Mercy Hospital
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Monroe, Michigan, Verenigde Staten, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, Verenigde Staten, 48162
- Mercy Memorial Hospital - Monroe
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Pontiac, Michigan, Verenigde Staten, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, Verenigde Staten, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, Verenigde Staten, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Saint Joseph, Michigan, Verenigde Staten, 49085
- Lakeside Cancer Specialists, PLLC
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St. Joseph, Michigan, Verenigde Staten, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Warren, Michigan, Verenigde Staten, 48093
- St. John Macomb Hospital
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Minnesota
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Alexandria, Minnesota, Verenigde Staten, 56308
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Bemidji, Minnesota, Verenigde Staten, 56601
- MeritCare Bemidji
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Burnsville, Minnesota, Verenigde Staten, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Verenigde Staten, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Edina, Minnesota, Verenigde Staten, 55435
- Fairview Southdale Hospital
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Fergus Falls, Minnesota, Verenigde Staten, 56537
- Fergus Falls Medical Group, PA
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Fridley, Minnesota, Verenigde Staten, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Verenigde Staten, 55350
- Hutchinson Area Health Care
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Maplewood, Minnesota, Verenigde Staten, 55109
- Minnesota Oncology Hematology, PA - Maplewood
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Maplewood, Minnesota, Verenigde Staten, 55109
- HealthEast Cancer Care at St. John's Hospital
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Minneapolis, Minnesota, Verenigde Staten, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, Verenigde Staten, 55415
- Hennepin County Medical Center - Minneapolis
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Robbinsdale, Minnesota, Verenigde Staten, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Verenigde Staten, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, Verenigde Staten, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, Verenigde Staten, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Verenigde Staten, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, Verenigde Staten, 55102
- United Hospital
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Shakopee, Minnesota, Verenigde Staten, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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St. Paul, Minnesota, Verenigde Staten, 55101
- Regions Hospital Cancer Care Center
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Waconia, Minnesota, Verenigde Staten, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, Verenigde Staten, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Montana
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Billings, Montana, Verenigde Staten, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Verenigde Staten, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Billings, Montana, Verenigde Staten, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Verenigde Staten, 59101
- St. Vincent Healthcare Cancer Care Services
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Billings, Montana, Verenigde Staten, 59107-7000
- Billings Clinic - Downtown
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Bozeman, Montana, Verenigde Staten, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Verenigde Staten, 59701
- St. James Healthcare Cancer Care
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Great Falls, Montana, Verenigde Staten, 59405
- Great Falls Clinic - Main Facility
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Great Falls, Montana, Verenigde Staten, 59405
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Great Falls, Montana, Verenigde Staten, 59405-5309
- Big Sky Oncology
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Great Falls, Montana, Verenigde Staten, 59405
- Sletten Cancer Institute at Benefis Healthcare
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Havre, Montana, Verenigde Staten, 59501
- Northern Montana Hospital
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Helena, Montana, Verenigde Staten, 59601
- St. Peter's Hospital
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Kalispell, Montana, Verenigde Staten, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, Verenigde Staten, 59901
- Kalispell Medical Oncology at KRMC
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Missoula, Montana, Verenigde Staten, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, Verenigde Staten, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, Verenigde Staten, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nebraska
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Lincoln, Nebraska, Verenigde Staten, 68510
- Cancer Resource Center - Lincoln
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Omaha, Nebraska, Verenigde Staten, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Verenigde Staten, 68122
- Immanuel Medical Center
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Omaha, Nebraska, Verenigde Staten, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, Verenigde Staten, 68131-2197
- Creighton University Medical Center
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North Carolina
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Rutherfordton, North Carolina, Verenigde Staten, 28139
- Rutherford Hospital
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North Dakota
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Bismarck, North Dakota, Verenigde Staten, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, Verenigde Staten, 58501
- Medcenter One Hospital Cancer Care Center
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Bismarck, North Dakota, Verenigde Staten, 58501
- Mid Dakota Clinic, PC
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Bismarck, North Dakota, Verenigde Staten, 58502
- St. Alexius Medical Center Cancer Center
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Fargo, North Dakota, Verenigde Staten, 58122
- CCOP - MeritCare Hospital
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Fargo, North Dakota, Verenigde Staten, 58122
- MeritCare Broadway
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Grand Forks, North Dakota, Verenigde Staten, 58201
- Altru Cancer Center at Altru Hospital
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Ohio
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Bowling Green, Ohio, Verenigde Staten, 43402
- Wood County Oncology Center
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Clyde, Ohio, Verenigde Staten, 43410
- North Coast Cancer Care - Clyde
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Dayton, Ohio, Verenigde Staten, 45405
- Grandview Hospital
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Dayton, Ohio, Verenigde Staten, 45406
- Good Samaritan Hospital
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Dayton, Ohio, Verenigde Staten, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
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Dayton, Ohio, Verenigde Staten, 45415
- Samaritan North Cancer Care Center
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Dayton, Ohio, Verenigde Staten, 45420
- CCOP - Dayton
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Elyria, Ohio, Verenigde Staten, 44035
- Community Cancer Center
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Elyria, Ohio, Verenigde Staten, 44035
- Hematology Oncology Center
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Findlay, Ohio, Verenigde Staten, 45840
- Blanchard Valley Medical Associates
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Franklin, Ohio, Verenigde Staten, 45005-1066
- Middletown Regional Hospital
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Greenville, Ohio, Verenigde Staten, 45331
- Wayne Hospital
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Kettering, Ohio, Verenigde Staten, 45429
- Charles F. Kettering Memorial Hospital
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Lima, Ohio, Verenigde Staten, 45804
- Lima Memorial Hospital
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Maumee, Ohio, Verenigde Staten, 43537
- St. Luke's Hospital
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Maumee, Ohio, Verenigde Staten, 43537-1839
- Northwest Ohio Oncology Center
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Norwalk, Ohio, Verenigde Staten, 44857
- Fisher-Titus Medical Center
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Oregon, Ohio, Verenigde Staten, 43616
- St. Charles Mercy Hospital
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Oregon, Ohio, Verenigde Staten, 43616
- Toledo Clinic - Oregon
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Sandusky, Ohio, Verenigde Staten, 44870
- North Coast Cancer Care, Incorporated
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Sylvania, Ohio, Verenigde Staten, 43560
- Flower Hospital Cancer Center
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Tiffin, Ohio, Verenigde Staten, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, Verenigde Staten, 43608
- St. Vincent Mercy Medical Center
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Toledo, Ohio, Verenigde Staten, 43606
- Toledo Hospital
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Toledo, Ohio, Verenigde Staten, 43614
- Medical University of Ohio Cancer Center
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Toledo, Ohio, Verenigde Staten, 43617
- CCOP - Toledo Community Hospital
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Toledo, Ohio, Verenigde Staten, 43623
- Toledo Clinic, Incorporated - Main Clinic
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Toledo, Ohio, Verenigde Staten, 43623
- St. Anne Mercy Hospital
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Troy, Ohio, Verenigde Staten, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
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Wauseon, Ohio, Verenigde Staten, 43567
- Fulton County Health Center
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Wilmington, Ohio, Verenigde Staten, 45177
- Clinton Memorial Hospital
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Xenia, Ohio, Verenigde Staten, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Oklahoma
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Tulsa, Oklahoma, Verenigde Staten, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
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Oregon
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Milwaukie, Oregon, Verenigde Staten, 97222
- Providence Milwaukie Hospital
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Portland, Oregon, Verenigde Staten, 97216
- Adventist Medical Center
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Portland, Oregon, Verenigde Staten, 97213-2967
- Providence Cancer Center at Providence Portland Medical Center
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Portland, Oregon, Verenigde Staten, 97225
- CCOP - Columbia River Oncology Program
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Portland, Oregon, Verenigde Staten, 97225
- Providence St. Vincent Medical Center
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Pennsylvania
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Allentown, Pennsylvania, Verenigde Staten, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
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Danville, Pennsylvania, Verenigde Staten, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Hazleton, Pennsylvania, Verenigde Staten, 18201
- Geisinger Hazleton Cancer Center
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Sayre, Pennsylvania, Verenigde Staten, 18840
- Guthrie Cancer Center at Guthrie Clinic Sayre
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State College, Pennsylvania, Verenigde Staten, 16801
- Geisinger Medical Group - Scenery Park
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Wilkes-Barre, Pennsylvania, Verenigde Staten, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
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South Carolina
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Anderson, South Carolina, Verenigde Staten, 29621
- AnMed Cancer Center
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Spartanburg, South Carolina, Verenigde Staten, 29303
- CCOP - Upstate Carolina
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Spartanburg, South Carolina, Verenigde Staten, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
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-
South Dakota
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Rapid City, South Dakota, Verenigde Staten, 57701
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Verenigde Staten, 57105
- Medical X-Ray Center, PC
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Sioux Falls, South Dakota, Verenigde Staten, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
-
-
Virginia
-
Fredericksburg, Virginia, Verenigde Staten, 22401
- Fredericksburg Oncology, Incorporated
-
-
Washington
-
Vancouver, Washington, Verenigde Staten, 98668
- Southwest Washington Medical Center Cancer Center
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-
Wisconsin
-
Chippewa Falls, Wisconsin, Verenigde Staten, 54729
- Marshfield Clinic - Chippewa Center
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Eau Claire, Wisconsin, Verenigde Staten, 54701
- Marshfield Clinic Cancer Care at Regional Cancer Center
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Eau Claire, Wisconsin, Verenigde Staten, 54703-1510
- Midelfort Clinic - Luther
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Eau Claire, Wisconsin, Verenigde Staten, 54702
- Luther Midlelfort Hospital
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Green Bay, Wisconsin, Verenigde Staten, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Verenigde Staten, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Verenigde Staten, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
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Green Bay, Wisconsin, Verenigde Staten, 54303
- St. Mary's Hospital Medical Center - Green Bay
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Manitowoc, Wisconsin, Verenigde Staten, 54221-1450
- Holy Family Memorial Medical Center Cancer Care Center
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Marinette, Wisconsin, Verenigde Staten, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
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Marshfield, Wisconsin, Verenigde Staten, 54449
- Marshfield Clinic - Marshfield Center
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Minocqua, Wisconsin, Verenigde Staten, 54548
- Marshfield Clinic - Lakeland Center
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Oconto Falls, Wisconsin, Verenigde Staten, 54154
- Green Bay Oncology, Limited - Oconto Falls
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Rhinelander, Wisconsin, Verenigde Staten, 54501
- Ministry Medical Group at Saint Mary's Hospital
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Rice Lake, Wisconsin, Verenigde Staten, 54868
- Marshfield Clinic - Indianhead Center
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Stevens Point, Wisconsin, Verenigde Staten, 54481
- Marshfield Clinic at Saint Michael's Hospital
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Sturgeon Bay, Wisconsin, Verenigde Staten, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
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Wausau, Wisconsin, Verenigde Staten, 54401
- Marshfield Clinic - Wausau Center
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Weston, Wisconsin, Verenigde Staten, 54476
- Marshfield Clinic - Weston Center
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Wisconsin Rapids, Wisconsin, Verenigde Staten, 54494
- Marshfield Clinic - Wisconsin Rapids Center
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Wyoming
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Casper, Wyoming, Verenigde Staten, 82609
- Rocky Mountain Oncology
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Sheridan, Wyoming, Verenigde Staten, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas (ductal or undifferentiated)
- Metastatic disease
- No islet cell, acinar cell, or cystadenocarcinomas
- No locally advanced disease
- No history or known presence of CNS metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 3 months
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Total bilirubin ≤ 2 times upper limit of normal (ULN) (patients may be stented)
- AST ≤ 2.5 times ULN
- Creatinine ≤ 2.0 times ULN
- Magnesium ≥ lower limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Willing to provide a stool specimen
- No malignancy diagnosed within the past 3 years except basal cell or squamous cell skin cancer, prostate cancer (Gleason < 7), or carcinoma in situ of the cervix
- No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
- No clinically significant cardiovascular disease (i.e., myocardial infarction, unstable angina, symptomatic congestive heart failure, or serious uncontrolled cardiac arrhythmia) within the past year
- No known positive test(s) for HIV infection, hepatitis C virus, or acute or chronic active hepatitis B infection
- No liver dysfunction from cirrhosis or viral hepatitis
- No enteral hyperalimentation
- No grapefruit or grapefruit juice during the study
PRIOR CONCURRENT THERAPY:
- Recovered from prior therapy
- More than 4 months since prior radiotherapy, immunotherapy, or biologic therapy
- More than 4 weeks since prior and no elective or planned major surgery
- More than 2 weeks since prior minor and no elective or planned surgery
No prior cytotoxic chemotherapy for metastatic disease
Adjuvant chemotherapy for completely resected disease or chemoradiotherapy for locally advanced disease is allowed, provided it was administered > 6 months prior to study entry
- Adjuvant chemotherapy must not have contained an EGFR inhibitor
- Gemcitabine hydrochloride used as either a radiosensitizer or as maintenance therapy is allowed, provided more than 6 months have elapsed since the last day of treatment
- No prior anti-EGFR antibody therapy (e.g., cetuximab) or treatment with small molecule EGFR inhibitors (e.g., gefitinib hydrochloride, erlotinib hydrochloride, or lapatinib)
- No concurrent immunotherapy or radiotherapy
- No other concurrent chemotherapy
- No concurrent colony-stimulating factors during the first course of study therapy
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Arm A: GE
Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28.
Treatment repeats every 28 days for 2 courses.
Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above.
Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression.
After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
|
IV gegeven
Mondeling gegeven
|
|
Experimenteel: Arm B: PGE
Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15.
Treatment repeats every 28 days for 2 courses.
Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above.
Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression.
After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
|
IV gegeven
Mondeling gegeven
IV gegeven
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall Survival
Tijdsspanne: Up to 2 years
|
Overall Survival is defined as the time from registration to death due to any cause.
The estimate will be done using the Kaplan-Meier method.
The primary goal of this trial is to compare the experimental arm (Arm B) to the standard arm (Arm A).
The primary analysis will be a comparison of Arm A to Arm B using a one-sided log-rank test between the 2 Kaplan-Meier curves.
|
Up to 2 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Confirmed Response Rate
Tijdsspanne: Up to 2 years
|
Evaluated using RECIST version 1.0.
Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart.
CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD.
The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.
|
Up to 2 years
|
|
Progression-free Survival
Tijdsspanne: Up to 2 years
|
Progression-free survival is defined as the time from randomization to documentation of disease progression or death, whichever comes first.
Progression is defined as at least a 20% increase in the sum of longest dimension (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
The progression-free survival curves will be compared between the 2 arms using a log-rank test.
|
Up to 2 years
|
|
Time to Treatment Failure
Tijdsspanne: Up to 2 years
|
Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal.
If the patient is considered to be a major treatment violation or is taken off study as a nonprotocol failure, the patient will be censored on the date they are removed from treatment.
The time to treatment failure will be estimated using the method of Kaplan-Meier.
|
Up to 2 years
|
|
Frequency and Severity of Observed Adverse Effects
Tijdsspanne: Up to 2 years
|
Patients are assessed for Adverse events each cycle using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). The maximum grade for each type of adverse event will be recorded for each patient, and tables will be reviewed to determine adverse event patterns. The number of patients in each arm that reported a grade 3 or higher adverse event and a grade 4 or higher adverse event are reported. A complete listing of all adverse events is reported in the Adverse Events section. |
Up to 2 years
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Studie stoel: George P. Kim, MD, Mayo Clinic
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2009
Primaire voltooiing (Werkelijk)
1 november 2010
Studie voltooiing (Werkelijk)
1 mei 2013
Studieregistratiedata
Eerst ingediend
26 oktober 2007
Eerst ingediend dat voldeed aan de QC-criteria
26 oktober 2007
Eerst geplaatst (Schatting)
30 oktober 2007
Updates van studierecords
Laatste update geplaatst (Werkelijk)
5 april 2017
Laatste update ingediend die voldeed aan QC-criteria
21 februari 2017
Laatst geverifieerd
1 februari 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Neoplasmata
- Neoplasmata per site
- Endocriene systeemziekten
- Neoplasmata van het spijsverteringsstelsel
- Endocriene klierneoplasmata
- Alvleesklier Ziekten
- Pancreasneoplasmata
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Antivirale middelen
- Enzymremmers
- Antimetabolieten, antineoplastische
- Antimetabolieten
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Antineoplastische middelen, immunologisch
- Proteïnekinaseremmers
- Gemcitabine
- Erlotinibhydrochloride
- Panitumumab
Andere studie-ID-nummers
- NCCTG-N064B
- NCI-2009-01089 (Register-ID: CTRP (Clinical Trials Reporting System))
- CDR0000571863 (Register-ID: PDQ (Physician Data Query))
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .