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