Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT00601627
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00601627
Study Brief:
Protocol Section:
NCT00601627