Panitumumab, Chemotherapy, and External-Beam Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot be Removed by Surgery



Status:Completed
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2009
End Date:May 2013

Use our guide to learn which trials are right for you!

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

- 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.

Secondary

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

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

OUTLINE:

- 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.

DISEASE CHARACTERISTICS:

- 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

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:

- Ongoing or active infection

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

- 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

PRIOR CONCURRENT THERAPY:

- More than 21 days since prior laparotomy

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

- 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
corticosteroids)

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

- No other concurrent immunotherapy or radiotherapy
We found this trial at
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550 Osborne Road
Fridley, Minnesota 55432
763-236-5000
Mercy and Unity Cancer Center at Unity Hospital Patients and their families are the heart...
629
mi
from 43215
Fridley, MN
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Galesburg, Illinois 61401
391
mi
from 43215
Galesburg, IL
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