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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01088 | Registry Identifier | CTRP (Clinical Trials Reporting System) | |
| CDR0000584104 | Registry Identifier | PDQ (Physician Data Query) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: 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. Drugs used in chemotherapy, such as fluorouracil, capecitabine, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Panitumumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor and make tumor cells more sensitive to radiation therapy. Giving panitumumab together with chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving panitumumab together with chemotherapy and external-beam radiation therapy works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE:
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panitumumab | Experimental | Chemotherapy concurrent with radiation: Radiation 5 days per week for 5½ weeks; Panitumumab on days 1, 15, and 29 of radiation therapy 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation. 4-6 weeks after completion of radiation therapy: Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; Panitumumab on days 1 and 15 of each cycle, for 3 cycles. Maintenance therapy: Panitumumab on days 1 and 15 of each cycle, for 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| panitumumab | Biological |
| ||
| capecitabine |
| Measure | Description | Time Frame |
|---|---|---|
| One Year Survival Rate | The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the exact binomial method. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier | baseline to 2 years |
| Progression Free Survival (PFS) |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed unresectable adenocarcinoma of the pancreas
Including subtotal resection and gross residual disease
Measurable disease is not required
Disease is encompassable within standard radiotherapy fields for pancreatic cancer
No evidence of metastatic disease outside of the planned radiotherapy field
No cystadenocarcinoma of the pancreas or pancreatic tumors of neuroendocrine origin
No distant metastases (i.e., liver or lung metastases or peritoneal spread)
No history or known presence of CNS metastases
PATIENT CHARACTERISTICS:
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
ANC ≥ 1,500/mm³
Hemoglobin ≥ 9.0 g/dL
Platelet count ≥ 100,000/mm³
Total bilirubin ≤ 3 times upper limit of normal (ULN)* NOTE: *Biliary stent placement or surgical bypass should be considered prior to treatment if impending bile duct obstruction by tumor
AST ≤ 3 times ULN
Creatinine ≤ 2.0 times ULN
Magnesium normal
Willing to return to an North Central Cancer Treatment Group (NCCTG) institution for follow-up
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for at least 6 months after treatment with panitumumab
No prior or concurrent malignancy unless disease-free ≥ 3 years except for non-melanoma skin cancer, carcinoma in situ of the cervix, or organ confined prostate cancer with Gleason score < 7
No nausea or vomiting > grade 1
No uncontrolled intercurrent illness including, but not limited to, any the following:
No New York Heart Association clinically significant cardiovascular disease ≥ grade 2, including any of the following within the past year:
No known HIV positivity
No known hepatitis C virus or acute or chronic active hepatitis B infection
Adequate oral nutrition
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| George Kim, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora Presbyterian Hospital | Aurora | Colorado | 80012 | United States | ||
| Boulder Community Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35285484 | Derived | Halfdanarson TR, Foster NR, Kim GP, Haddock MG, Dakhil SR, Behrens RJ, Alberts SR. N064A (Alliance): Phase II Study of Panitumumab, Chemotherapy, and External Beam Radiation in Patients with Locally Advanced Pancreatic Adenocarcinoma. Oncologist. 2022 Jul 5;27(7):534-e546. doi: 10.1093/oncolo/oyac002. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Panitumumab | Chemotherapy concurrent with radiation: Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation. 4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles. Maintenance therapy: 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| fluorouracil | Drug |
|
| gemcitabine hydrochloride | Drug |
|
| radiation therapy | Radiation |
|
Progression Free Survival is defined as the time from registration to the earliest documented evidence of disease progression.
| baseline to 2 years |
| Confirmed Response Rate | A confirmed tumor response is defined to be a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. A complete response is defined as the disappearance of all target and non-target lesions. A partial response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of the target lesion from baseline. Confirmed tumor response will be evaluated using the first 6 cycles of treatment. | baseline to 2 years |
| Duration of Response | Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented. | baseline to 2 years |
| Time to Treatment Failure | Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. The distribution of survival time will be estimated using the method of Kaplan-Meier. | baseline to 2 years |
| Boulder |
| Colorado |
| 80301-9019 |
| United States |
| Penrose Cancer Center at Penrose Hospital | Colorado Springs | Colorado | 80933 | United States |
| St. Anthony Central Hospital | Denver | Colorado | 80204 | United States |
| Porter Adventist Hospital | Denver | Colorado | 80210 | United States |
| Presbyterian - St. Luke's Medical Center | Denver | Colorado | 80218 | United States |
| St. Joseph Hospital | Denver | Colorado | 80218 | United States |
| Rose Medical Center | Denver | Colorado | 80220 | United States |
| CCOP - Colorado Cancer Research Program | Denver | Colorado | 80224-2522 | United States |
| Swedish Medical Center | Englewood | Colorado | 80110 | United States |
| Front Range Cancer Specialists | Fort Collins | Colorado | 80528 | United States |
| St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction | Colorado | 81502 | United States |
| North Colorado Medical Center | Greeley | Colorado | 80631 | United States |
| Sky Ridge Medical Center | Lone Tree | Colorado | 80124 | United States |
| Hope Cancer Care Center at Longmont United Hospital | Longmont | Colorado | 80501 | United States |
| McKee Medical Center | Loveland | Colorado | 80539 | United States |
| St. Mary - Corwin Regional Medical Center | Pueblo | Colorado | 81004 | United States |
| North Suburban Medical Center | Thornton | Colorado | 80229 | United States |
| Exempla Lutheran Medical Center | Wheat Ridge | Colorado | 80033 | United States |
| Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford | Connecticut | 06105 | United States |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | United States |
| Illinois CancerCare - Bloomington | Bloomington | Illinois | 61701 | United States |
| St. Joseph Medical Center | Bloomington | Illinois | 61701 | United States |
| Graham Hospital | Canton | Illinois | 61520 | United States |
| Illinois CancerCare - Canton | Canton | Illinois | 61520 | United States |
| Illinois CancerCare - Carthage | Carthage | Illinois | 62321 | United States |
| Memorial Hospital | Carthage | Illinois | 62321 | United States |
| Eureka Community Hospital | Eureka | Illinois | 61530 | United States |
| Illinois CancerCare - Eureka | Eureka | Illinois | 61530 | United States |
| Galesburg Clinic, PC | Galesburg | Illinois | 61401 | United States |
| Galesburg Cottage Hospital | Galesburg | Illinois | 61401 | United States |
| Illinois CancerCare - Galesburg | Galesburg | Illinois | 61401 | United States |
| InterCommunity Cancer Center of Western Illinois | Galesburg | Illinois | 61401 | United States |
| Illinois CancerCare - Havana | Havana | Illinois | 62644 | United States |
| Mason District Hospital | Havana | Illinois | 62644 | United States |
| Illinois CancerCare - Kewanee Clinic | Kewanee | Illinois | 61443 | United States |
| Illinois CancerCare - Macomb | Macomb | Illinois | 61455 | United States |
| McDonough District Hospital | Macomb | Illinois | 61455 | United States |
| Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | Moline | Illinois | 61265 | United States |
| Moline | Illinois | 61265 | United States |
| Illinois CancerCare - Monmouth | Monmouth | Illinois | 61462 | United States |
| OSF Holy Family Medical Center | Monmouth | Illinois | 61462 | United States |
| BroMenn Regional Medical Center | Normal | Illinois | 61761 | United States |
| Community Cancer Center | Normal | Illinois | 61761 | United States |
| Illinois CancerCare - Community Cancer Center | Normal | Illinois | 61761 | United States |
| Community Hospital of Ottawa | Ottawa | Illinois | 61350 | United States |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois | 61350 | United States |
| Illinois CancerCare - Pekin | Pekin | Illinois | 61603 | United States |
| Proctor Hospital | Peoria | Illinois | 61614 | United States |
| OSF St. Francis Medical Center | Peoria | Illinois | 61615-7827 | United States |
| CCOP - Illinois Oncology Research Association | Peoria | Illinois | 61615 | United States |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois | 61615 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | United States |
| Illinois CancerCare - Peru | Peru | Illinois | 61354 | United States |
| Illinois Valley Community Hospital | Peru | Illinois | 61354 | United States |
| Illinois CancerCare - Princeton | Princeton | Illinois | 61356 | United States |
| Perry Memorial Hospital | Princeton | Illinois | 61356 | United States |
| Illinois CancerCare - Spring Valley | Spring Valley | Illinois | 61362 | United States |
| Valley Cancer Center | Spring Valley | Illinois | 61362 | United States |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | 46107 | United States |
| Elkhart Clinic, LLC | Elkhart | Indiana | 46514-2098 | United States |
| Elkhart General Hospital | Elkhart | Indiana | 46515 | United States |
| Howard Community Hospital | Kokomo | Indiana | 46904 | United States |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana | 46350 | United States |
| Reid Hospital & Health Care Services | Richmond | Indiana | 47374 | United States |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| Michiana Hematology-Oncology, PC - South Bend | South Bend | Indiana | 46601 | United States |
| Saint Joseph Regional Medical Center | South Bend | Indiana | 46617 | United States |
| South Bend Clinic | South Bend | Indiana | 46617 | United States |
| McFarland Clinic, PC | Ames | Iowa | 50010 | United States |
| Bettendorf | Iowa | 52722 | United States |
| Cedar Rapids Oncology Associates | Cedar Rapids | Iowa | 52403 | United States |
| Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids | Iowa | 52403 | United States |
| Medical Oncology and Hematology Associates - West Des Moines | Clive | Iowa | 50325 | United States |
| Mercy Capitol Hospital | Des Moines | Iowa | 50307 | United States |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309 | United States |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa | 50314 | United States |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | United States |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines | Iowa | 50316 | United States |
| Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City | Iowa | 50401 | United States |
| McCreery Cancer Center at Ottumwa Regional | Ottumwa | Iowa | 52501 | United States |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | 51101 | United States |
| Mercy Medical Center - Sioux City | Sioux City | Iowa | 51104 | United States |
| St. Luke's Regional Medical Center | Sioux City | Iowa | 51104 | United States |
| Hospital District Sixth of Harper County | Anthony | Kansas | 67003 | United States |
| Cancer Center of Kansas, PA - Chanute | Chanute | Kansas | 66720 | United States |
| Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | 67801 | United States |
| Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | 67042 | United States |
| Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | 66701 | United States |
| Cancer Center of Kansas-Independence | Independence | Kansas | 67301 | United States |
| Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | 67068 | United States |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | United States |
| Southwest Medical Center | Liberal | Kansas | 67901 | United States |
| Cancer Center of Kansas, PA - Liberal | Liberal | Kansas | 67905 | United States |
| Cancer Center of Kansas, PA - Newton | Newton | Kansas | 67114 | United States |
| Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | 67357 | United States |
| Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | 67124 | United States |
| Cancer Center of Kansas, PA - Salina | Salina | Kansas | 67401 | United States |
| Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | 67152 | United States |
| Associates in Womens Health, PA - North Review | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | 67214 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214 | United States |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | 67214 | United States |
| Wesley Medical Center | Wichita | Kansas | 67214 | United States |
| Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | 67156 | United States |
| Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan | 49221 | United States |
| Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan | 48106-0995 | United States |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | United States |
| Battle Creek Health System Cancer Care Center | Battle Creek | Michigan | 49017 | United States |
| Mecosta County Medical Center | Big Rapids | Michigan | 49307 | United States |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan | 48123-2500 | United States |
| Green Bay Oncology, Limited - Escanaba | Escanaba | Michigan | 49431 | United States |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| CCOP - Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan | 49503 | United States |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| Dickinson County Healthcare System | Iron Mountain | Michigan | 49801 | United States |
| Foote Memorial Hospital | Jackson | Michigan | 49201 | United States |
| Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville | Michigan | 48144 | United States |
| Sparrow Regional Cancer Center | Lansing | Michigan | 48912-1811 | United States |
| St. Mary Mercy Hospital | Livonia | Michigan | 48154 | United States |
| Community Cancer Center of Monroe | Monroe | Michigan | 48162 | United States |
| Mercy Memorial Hospital - Monroe | Monroe | Michigan | 48162 | United States |
| Mercy General Health Partners | Muskegon | Michigan | 49443 | United States |
| St. Joseph Mercy Oakland | Pontiac | Michigan | 48341-2985 | United States |
| Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan | 48060 | United States |
| Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan | 48601 | United States |
| Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan | 49085 | United States |
| Lakeside Cancer Specialists, PLLC | Saint Joseph | Michigan | 49085 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| St. John Macomb Hospital | Warren | Michigan | 48093 | United States |
| Metro Health Hospital | Wyoming | Michigan | 49519 | United States |
| MeritCare Bemidji | Bemidji | Minnesota | 56601 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | United States |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota | 55805-1983 | United States |
| CCOP - Duluth | Duluth | Minnesota | 55805 | United States |
| Miller - Dwan Medical Center | Duluth | Minnesota | 55805 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | 55432 | United States |
| Hutchinson Area Health Care | Hutchinson | Minnesota | 55350 | United States |
| HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota | 55109 | United States |
| Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota | 55109 | United States |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota | 55415 | United States |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota | 55422-2900 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Park Nicollet Cancer Center | Saint Louis Park | Minnesota | 55416 | United States |
| Regions Hospital Cancer Care Center | Saint Paul | Minnesota | 55101 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota | 55379 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | United States |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | 55125 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65802 | United States |
| St. John's Regional Health Center | Springfield | Missouri | 65804 | United States |
| Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri | 65807 | United States |
| Missouri Baptist Cancer Center | St Louis | Missouri | 63131 | United States |
| Arch Medical Services, Incorporated at Center for Cancer Care and Research | St Louis | Missouri | 63141 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | 59101 | United States |
| Northern Rockies Radiation Oncology Center | Billings | Montana | 59101 | United States |
| St. Vincent Healthcare Cancer Care Services | Billings | Montana | 59101 | United States |
| Billings Clinic - Downtown | Billings | Montana | 59107-7000 | United States |
| Bozeman Deaconess Cancer Center | Bozeman | Montana | 59715 | United States |
| St. James Healthcare Cancer Care | Butte | Montana | 59701 | United States |
| Big Sky Oncology | Great Falls | Montana | 59405-5309 | United States |
| Great Falls Clinic - Main Facility | Great Falls | Montana | 59405 | United States |
| Sletten Cancer Institute at Benefis Healthcare | Great Falls | Montana | 59405 | United States |
| Great Falls | Montana | 59405 | United States |
| Northern Montana Hospital | Havre | Montana | 59501 | United States |
| St. Peter's Hospital | Helena | Montana | 59601 | United States |
| Glacier Oncology, PLLC | Kalispell | Montana | 59901 | United States |
| Kalispell Medical Oncology at KRMC | Kalispell | Montana | 59901 | United States |
| Kalispell Regional Medical Center | Kalispell | Montana | 59901 | United States |
| Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | 59807-7877 | United States |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | 59807 | United States |
| Rutherford Hospital | Rutherfordton | North Carolina | 28139 | United States |
| Bismarck Cancer Center | Bismarck | North Dakota | 58501 | United States |
| Medcenter One Hospital Cancer Care Center | Bismarck | North Dakota | 58501 | United States |
| Mid Dakota Clinic, PC | Bismarck | North Dakota | 58501 | United States |
| St. Alexius Medical Center Cancer Center | Bismarck | North Dakota | 58502 | United States |
| CCOP - MeritCare Hospital | Fargo | North Dakota | 58122 | United States |
| MeritCare Broadway | Fargo | North Dakota | 58122 | United States |
| Mary Rutan Hospital | Bellefontaine | Ohio | 43311 | United States |
| Wood County Oncology Center | Bowling Green | Ohio | 43402 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| North Coast Cancer Care - Clyde | Clyde | Ohio | 43410 | United States |
| Riverside Methodist Hospital Cancer Care | Columbus | Ohio | 43214-3998 | United States |
| CCOP - Columbus | Columbus | Ohio | 43215 | United States |
| Grant Medical Center Cancer Care | Columbus | Ohio | 43215 | United States |
| Mount Carmel Health - West Hospital | Columbus | Ohio | 43222 | United States |
| Doctors Hospital at Ohio Health | Columbus | Ohio | 43228 | United States |
| Grandview Hospital | Dayton | Ohio | 45405 | United States |
| Good Samaritan Hospital | Dayton | Ohio | 45406 | United States |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Samaritan North Cancer Care Center | Dayton | Ohio | 45415 | United States |
| CCOP - Dayton | Dayton | Ohio | 45420 | United States |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | United States |
| Community Cancer Center | Elyria | Ohio | 44035 | United States |
| Hematology Oncology Center | Elyria | Ohio | 44035 | United States |
| Blanchard Valley Medical Associates | Findlay | Ohio | 45840 | United States |
| Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | United States |
| Wayne Hospital | Greenville | Ohio | 45331 | United States |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | United States |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | United States |
| Lima Memorial Hospital | Lima | Ohio | 45804 | United States |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio | 45750 | United States |
| Northwest Ohio Oncology Center | Maumee | Ohio | 43537-1839 | United States |
| St. Luke's Hospital | Maumee | Ohio | 43537 | United States |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio | 43055 | United States |
| Fisher-Titus Medical Center | Norwalk | Ohio | 44857 | United States |
| St. Charles Mercy Hospital | Oregon | Ohio | 43616 | United States |
| Toledo Clinic - Oregon | Oregon | Ohio | 43616 | United States |
| North Coast Cancer Care, Incorporated | Sandusky | Ohio | 44870 | United States |
| Mercy Medical Center | Springfield | Ohio | 45504 | United States |
| Community Hospital of Springfield and Clark County | Springfield | Ohio | 45505 | United States |
| Flower Hospital Cancer Center | Sylvania | Ohio | 43560 | United States |
| Mercy Hospital of Tiffin | Tiffin | Ohio | 44883 | United States |
| Toledo Hospital | Toledo | Ohio | 43606 | United States |
| St. Vincent Mercy Medical Center | Toledo | Ohio | 43608 | United States |
| Medical University of Ohio Cancer Center | Toledo | Ohio | 43614 | United States |
| CCOP - Toledo Community Hospital | Toledo | Ohio | 43617 | United States |
| St. Anne Mercy Hospital | Toledo | Ohio | 43623 | United States |
| Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio | 43623 | United States |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | 45373-1300 | United States |
| Fulton County Health Center | Wauseon | Ohio | 43567 | United States |
| Mount Carmel St. Ann's Cancer Center | Westerville | Ohio | 43081 | United States |
| Clinton Memorial Hospital | Wilmington | Ohio | 45177 | United States |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | 45385 | United States |
| Genesis - Good Samaritan Hospital | Zanesville | Ohio | 43701 | United States |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma | 74136 | United States |
| Providence Milwaukie Hospital | Milwaukie | Oregon | 97222 | United States |
| Providence Cancer Center at Providence Portland Medical Center | Portland | Oregon | 97213-2967 | United States |
| Adventist Medical Center | Portland | Oregon | 97216 | United States |
| CCOP - Columbia River Oncology Program | Portland | Oregon | 97225 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania | 18105 | United States |
| Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania | 17822-0001 | United States |
| Geisinger Hazleton Cancer Center | Hazleton | Pennsylvania | 18201 | United States |
| Geisinger Medical Group - Scenery Park | State College | Pennsylvania | 16801 | United States |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| AnMed Cancer Center | Anderson | South Carolina | 29621 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| Medical X-Ray Center, PC | Sioux Falls | South Dakota | 57105 | United States |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | 57117-5039 | United States |
| Fredericksburg Oncology, Incorporated | Fredericksburg | Virginia | 22401 | United States |
| Southwest Washington Medical Center Cancer Center | Vancouver | Washington | 98668 | United States |
| Marshfield Clinic - Chippewa Center | Chippewa Falls | Wisconsin | 54729 | United States |
| Center for Cancer Treatment & Prevention at Sacred Heart Hospital | Eau Claire | Wisconsin | 54701 | United States |
| Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire | Wisconsin | 54701 | United States |
| Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54301-3526 | United States |
| Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay | Wisconsin | 54303 | United States |
| St. Mary's Hospital Medical Center - Green Bay | Green Bay | Wisconsin | 54303 | United States |
| St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54307-3508 | United States |
| Holy Family Memorial Medical Center Cancer Care Center | Manitowoc | Wisconsin | 54221-1450 | United States |
| Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin | 54143 | United States |
| Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin | 54449 | United States |
| Saint Joseph's Hospital | Marshfield | Wisconsin | 54449 | United States |
| Marshfield Clinic - Lakeland Center | Minocqua | Wisconsin | 54548 | United States |
| Green Bay Oncology, Limited - Oconto Falls | Oconto Falls | Wisconsin | 54154 | United States |
| Ministry Medical Group at Saint Mary's Hospital | Rhinelander | Wisconsin | 54501 | United States |
| Marshfield Clinic - Indianhead Center | Rice Lake | Wisconsin | 54868 | United States |
| Marshfield Clinic at Saint Michael's Hospital | Stevens Point | Wisconsin | 54481 | United States |
| Saint Michael's Hospital Cancer Center | Stevens Point | Wisconsin | 54481 | United States |
| Door County Cancer Center at Door County Memorial Hospital | Sturgeon Bay | Wisconsin | 54235-1495 | United States |
| Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay | Wisconsin | 54235 | United States |
| Marshfield Clinic - Wausau Center | Wausau | Wisconsin | 54401 | United States |
| Diagnostic and Treatment Center | Weston | Wisconsin | 54476 | United States |
| Marshfield Clinic - Weston Center | Weston | Wisconsin | 54476 | United States |
| Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin | 54494 | United States |
| Rocky Mountain Oncology | Casper | Wyoming | 82609 | United States |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming | 82801 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
All patients were included in this analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Panitumumab | Chemotherapy concurrent with radiation: Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation. 4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles. Maintenance therapy: 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | One Year Survival Rate | The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the exact binomial method. | All patients were evaluable for this endpoint. | Posted | Number | 95% Confidence Interval | proportion of patients | Baseline to 12 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Overall Survival | Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier | All patients were evaluable for this endpoint. | Posted | Median | 95% Confidence Interval | months | baseline to 2 years |
|
| ||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | Progression Free Survival is defined as the time from registration to the earliest documented evidence of disease progression. | All patients were evaluable for this endpoint. | Posted | Median | 95% Confidence Interval | months | baseline to 2 years |
|
| ||||||||||||||||||||||||||
| Secondary | Confirmed Response Rate | A confirmed tumor response is defined to be a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. A complete response is defined as the disappearance of all target and non-target lesions. A partial response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of the target lesion from baseline. Confirmed tumor response will be evaluated using the first 6 cycles of treatment. | All patients were analyzed for this endpoint. | Posted | Number | 95% Confidence Interval | rate of confirmed response | baseline to 2 years |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented. | Too few patients reported a confirmed response to provide meaningful information into the duration of response. | Posted | baseline to 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Treatment Failure | Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. The distribution of survival time will be estimated using the method of Kaplan-Meier. | All patients were included in the analysis. | Posted | Median | 95% Confidence Interval | months | baseline to 2 years |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Panitumumab | 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles. | 29 | 51 | 51 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 10 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Colonic hemorrhage | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Duodenal obstruction | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Ear, nose and throat examination abnormal | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Esophageal stenosis | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Esophageal ulcer | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Small intestine ulcer | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 10 | Systematic Assessment |
| |
| Hepatobiliary disease | Hepatobiliary disorders | MedDRA 10 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Bladder infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Bilirubin increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| INR increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Leukocyte count decreased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Weight loss | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Blood glucose increased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum albumin decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum phosphate decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum potassium decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum sodium increased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Ischemia cerebrovascular | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 10 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Hand-and-foot syndrome | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 10 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 10 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 10 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 10 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Ear, nose and throat examination abnormal | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Intra-abdominal hemorrhage | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Esophageal infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Infectious colitis | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Opportunistic infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Bilirubin increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| INR increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Leukocyte count decreased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Weight loss | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Blood glucose increased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum albumin decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum calcium decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum magnesium decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum phosphate decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum potassium decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum potassium increased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum sodium decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Taste alteration | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 10 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 10 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Hand-and-foot syndrome | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | MedDRA 10 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 10 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 10 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George P. Kim, M.D. | Alliance for Clinical Trials in Oncology | 507-284-4918 |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| D000069287 | Capecitabine |
| D005472 | Fluorouracil |
| D000093542 | Gemcitabine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013812 | Therapeutics |
Not provided
Not provided
|
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