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Phase II Study of Panitumumab, Chemotherapy, and External Beam Radiation in Patients With Locally Advanced Pancreatic Cancer

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

Phase II Study of Panitumumab, Chemotherapy, and External Beam Radiation in Patients With Locally Advanced Pancreatic Cancer



- To evaluate the 1-year survival rate in patients with locally advanced pancreatic
cancer treated with panitumumab and continuous infusion fluorouracil administered
concurrently with external-beam radiotherapy followed by gemcitabine and panitumumab.


- To determine overall survival, time to disease progression, confirmed response rate,
duration of response, and time to treatment failure in patients treated with this

- To determine adverse events in patients treated with this regimen.


- Panitumumab and chemoradiotherapy : Patients undergo external-beam radiotherapy once
daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38. Patients also receive
panitumumab IV over 1 hour on days 1, 15, and 29 and fluorouracil IV continuously over
24 hours daily OR oral capecitabine twice daily beginning on day 1 and continuing
through the last day of radiotherapy.

- Panitumumab and chemotherapy: Beginning 4-6 weeks after completion of panitumumab and
chemoradiotherapy, patients receive panitumumab IV over 1 hour on days 1 and 15 and
gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days
for 3 courses. Patients then proceed to maintenance therapy.

- Maintenance therapy: Patients receive panitumumab IV over 1 hour on days 1 and 15.
Treatment repeats every 28 days for 6 courses in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 1 year.

Inclusion Criteria


- Histologically or cytologically confirmed unresectable adenocarcinoma of the pancreas

- Including subtotal resection and gross residual disease

- No microscopic residual disease only

- 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


- 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 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

- Ongoing or active infection

- Psychiatric illness or social situations that would limit compliance with study

- No New York Heart Association clinically significant cardiovascular disease ≥ grade
2, including any of the following within the past year:

- Myocardial infarction

- Unstable angina

- Symptomatic congestive heart failure

- Serious, uncontrolled cardiac arrhythmia

- No known HIV positivity

- No known hepatitis C virus or acute or chronic active hepatitis B infection

- Adequate oral nutrition


- More than 21 days since prior laparotomy

- No prior anti-epidermal growth factor receptor (EGFR) antibody therapy (e.g.,

- No prior small molecule EGFR inhibitors (e.g., gefitinib, erlotinib, or lapatinib)

- No prior radiotherapy that would overlap with planned radiotherapy fields

- No prior or other concurrent chemotherapy

- No prior or other concurrent biologic therapy

- More than 4 weeks since prior and no concurrent or planned participation in another
experimental drug study except studies with specific interventions intended to treat
rashes associated with EGFR agents (e.g., N05C4)

- No concurrent enteral hyperalimentation

- No concurrent chronic immunosuppressive agents (e.g., methotrexate, cyclosporine, or

- No concurrent colony-stimulating factors during the first course of therapy

- No other concurrent immunotherapy or radiotherapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

1-year survival rate

Safety Issue:


Principal Investigator

George P. Kim, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

June 2009

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • adenocarcinoma of the pancreas
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • Pancreatic Neoplasms



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St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction, Colorado  81502
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Hope Cancer Care Center at Longmont United Hospital Longmont, Colorado  80502
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Cedar Rapids Oncology Associates Cedar Rapids, Iowa  52403
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
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Miller - Dwan Medical Center Duluth, Minnesota  55805
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Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Hutchinson Area Health Care Hutchinson, Minnesota  55350
Minnesota Oncology Hematology, PA - Maplewood Maplewood, Minnesota  55109
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
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Geisinger Medical Group - Scenery Park State College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
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Medical University of Ohio Cancer Center Toledo, Ohio  43614
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Munson Medical Center Traverse City, Michigan  49684
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InterCommunity Cancer Center of Western Illinois Galesburg, Illinois  61401
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BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
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OSF St. Francis Medical Center Peoria, Illinois  61637
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Perry Memorial Hospital Princeton, Illinois  61356
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Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Lima Memorial Hospital Lima, Ohio  45804
St. Luke's Hospital Maumee, Ohio  43537
Northwest Ohio Oncology Center Maumee, Ohio  43537
Middletown Regional Hospital Middletown, Ohio  45044
Toledo Clinic - Oregon Oregon, Ohio  43616
St. Charles Mercy Hospital Oregon, Ohio  43616
North Coast Cancer Care, Incorporated Sandusky, Ohio  44870
Mercy Medical Center Springfield, Ohio  45504
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Toledo Clinic, Incorporated - Main Clinic Toledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
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Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
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Providence St. Vincent Medical Center Portland, Oregon  97225
Southwest Washington Medical Center Cancer Center Vancouver, Washington  98668
Holy Family Memorial Medical Center Cancer Care Center Manitowoc, Wisconsin  54221-1450
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
St. Anthony Central Hospital Denver, Colorado  80204-1335
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Missouri Baptist Cancer Center St. Louis, Missouri  63131
Elkhart Clinic, LLC Elkhart, Indiana  46514-2098
Michiana Hematology-Oncology, PC - South Bend Mishawaka, Indiana  46545-1470
Reid Hospital & Health Care Services Richmond, Indiana  47374
McFarland Clinic, PC Ames, Iowa  50010
Hospital District Sixth of Harper County Anthony, Kansas  67003
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Mercy Memorial Hospital - Monroe Monroe, Michigan  48162
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Arch Medical Services, Incorporated at Center for Cancer Care and Research Saint Louis, Missouri  63141
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Northern Montana Hospital Havre, Montana  59501
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Mary Rutan Hospital Bellefontaine, Ohio  43311
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Grant Medical Center Cancer Care Columbus, Ohio  43215
Hematology Oncology Center Elyria, Ohio  44035
Community Cancer Center Elyria, Ohio  44035
Wayne Hospital Greenville, Ohio  45331
Fisher-Titus Medical Center Norwalk, Ohio  44857
Flower Hospital Cancer Center Sylvania, Ohio  43560
St. Anne Mercy Hospital Toledo, Ohio  43623
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Clinton Memorial Hospital Wilmington, Ohio  45177
Adventist Medical Center Portland, Oregon  97216
Geisinger Hazleton Cancer Center Hazleton, Pennsylvania  18201
Fredericksburg Oncology, Incorporated Fredericksburg, Virginia  22401
Marshfield Clinic - Chippewa Center Chippewa Falls, Wisconsin  54729
Center for Cancer Treatment & Prevention at Sacred Heart Hospital Eau Claire, Wisconsin  54701
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Ministry Medical Group at Saint Mary's Hospital Rhinelander, Wisconsin  54501
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Diagnostic and Treatment Center Weston, Wisconsin  54476
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Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
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Galesburg Clinic, PC Galesburg, Illinois  61401
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
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Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline, Illinois  61265
OSF Holy Family Medical Center Monmouth, Illinois  61462
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Illinois CancerCare - Community Cancer Center Normal, Illinois  61761
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Mercy General Health Partners Muskegon, Michigan  49443
AnMed Cancer Center Anderson, South Carolina  29621
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
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