Clinical trial NCT00728000 (phase 2, status: withdrawn)
Conditions: pancreatic adenocarcinoma
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: gemcitabine, oxaliplatin, erlotinib
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, COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2
Reason stopped: 
    study withdrawn due to lack of enrollment
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a histologic or cytologic diagnosis of pancreatic adenocarcinoma.
             Patients with endocrine tumors or lymphoma of the pancreas are ineligible.

          -  Patients must have locally advanced disease that is considered to be "borderline"
             surgically resectable (see Section 4.0). Patients with metastatic disease or grossly
             resectable disease on presentation are ineligible.

          -  Patients must have measurable disease prior to starting this study. Patients with
             primarily non-measurable disease, including lesions to small to be characterized,
             effusions, ascites, diffuse bone disease, diffuse skin disease, leptomeningeal
             disease, lymphangitis, pneumonitis or disease measured by indirect or biochemical
             means, are not eligible. Testing for measurable disease must have been completed 28
             days prior to registration.

          -  Patients must consent to utilization of tissue for research in this protocol. Tissue
             will be evaluated via immunohistochemical staining for deoxycytidine kinase, ERCC-1
             and ERCC-2 (XPD). Patients may be asked if they are willing to allow their tissue to
             be used for future studies that are not defined in this protocol. Disallowing the use
             of tissue for future studies does not limit eligibility in this protocol.

          -  Patients must fulfill the required initial laboratory data to be obtained within 28
             days prior to registration: AGC ≥ 1,500cells/μL, Platelet ≥ 100,000cells/μL, Hgb > 8.0
             g/dl, Bilirubin ≤ 2.0 X IULN, Serum Creatinine ≤ 2.0mg/dL, AST(SGOT) ≤ 2.5x IULN,
             ALT(SGPT) ≤ 2.5x IULN, CA19-9 (any value),

          -  Patients must have an ECOG/Zubrod performance status of 0-2.

          -  Patients must be able to read and understand English in order to participate in this
             study, or have a certified translator present.

          -  Due to the potentially harmful effects of chemotherapy on a developing fetus, patients
             who are pregnant are planning to become pregnant, or who are lactating should not
             participate in this study.

          -  Women of childbearing potential must have a negative pregnancy test.

          -  Men and women of childbearing potential must be willing to consent to using effective
             contraception while on treatment and for at least 3 months thereafter.

          -  All patients must be informed of the investigational nature of this study and must
             sign, date and give written consent in accordance with institutional and federal
             guidelines.

          -  All patients must be18 years of age or older to participate.

        Exclusion Criteria:

          -  Patients with known brain metastases are ineligible. Brain imaging studies are not
             required for eligible patients with no neurologic signs or symptoms. If brain imaging
             studies are performed, they must be negative for disease.

          -  Patients who have had prior surgery for their pancreatic carcinoma are not eligible
             for this study. This does not include patients who have had cytologic brushing, fine
             needle aspiration or core biopsy of their tumor for diagnostic purposes.

          -  Patients must not have received prior chemotherapy, radiotherapy, chemoradiotherapy,
             surgery, immunotherapy or hormonal therapy for pancreatic cancer.

          -  Patients must not have received prior erlotinib or other therapies that target EGFR.
             Patients must not have received prior tyrosine kinase inhibitors.

          -  Have a significant history of uncontrolled cardiac disease including uncontrolled
             hypertension, unstable angina or uncontrolled congestive heart failure.

          -  Have a significant history of intersitital lung disease

          -  Have a significant history of peripheral neuropathy (grade must be <1) or
             mononeuropathy multiplex.

          -  Have temperature >101.30 F or active infection

          -  No other history of malignancy is allowed except for the following:

        adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.

          -  There must be no other plans for the patient to receive concurrent chemotherapy,
             radiotherapy, chemoradiotherapy, surgery, immunotherapy or hormonal therapy for the
             treatment of their cancer while on protocol.

          -  Due to the undetermined effect of chemotherapy in patients with HIV infection and the
             potential for serious interaction with anti-HIV medications, patients who are known to
             be infected with HIV are not eligible for this study. An HIV test is not required to
             participate.