Clinical trial NCT00601627 (phase 2, status: completed)
Conditions: pancreatic cancer
ICD codes: C25.3
Drugs: capecitabine, fluorouracil, gemcitabine hydrochloride
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
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