Clinical trial NCT00059826 (phase 2, status: completed)
Conditions: pancreatic cancer
ICD codes: C25.3
Drugs: cisplatin, 5-fluorouracil
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, FC1=CNC(=O)NC1=O
Eligibility criteria:

        Inclusion Criteria:

          1. Patient must be > 18 years of age.

          2. Patient must have a documented ECOG/Zubrod performance status of 0 or 1, within 7 days
             prior to registration.

          3. Patient must have pathological stage T1-3, N0-1, M0 adenocarcinoma of the head of the
             pancreas according to the American Joint Committee on Cancer (AJCC) staging system.

               -  NOTE: The pathology report must be submitted to ACOSOG on the Pathology Report
                  Shuttle CRF.

          4. Patient must have undergone a potentially curative gross total resection by
             pancreaticoduodenectomy (includes R0 [no residual tumor] or R1 [microscopic residual
             tumor]) within 56 days prior to beginning treatment. NOTE: The operative report must
             be submitted to ACOSOG on the Operative Report Shuttle CRF.

          5. Patient must have stable or increasing weight in the 14 days prior to the start of
             treatment, otherwise supplemental nutrition (e.g. feeding jejunostomy, PEG, TPN) must
             be initiated prior to the start of treatment.6. Patient must have adequate bone
             marrow, hepatic and renal function, within 7 days prior to registration:

               -  WBC > 3,000 mm^3

               -  ANC > 1,500 mm^3

               -  hemoglobin > 9.5 mg/dl

               -  platelet count > 100,000 mm^3

               -  total bilirubin < 3 mg/dl

               -  AST (SGOT) < 2.0 times institutional upper limit of normal (ULN)

               -  ALT (SGPT) < 2.0 times institutional ULN

               -  alkaline phosphatase < 2.0 times institutional ULN

               -  serum creatinine < 1.5 times institutional ULN

        7. Patient must have a baseline diagnostic CT scan of the chest and CT scan with IV
        contrast (or MRI) of abdomen/pelvis, within 30 days prior to registration, to exclude
        metastatic disease.

        8. If female of childbearing potential, patient must have a negative urine or serum
        pregnancy test, within 7 days prior to registration. NOTE: Postmenopausal women must have
        been amenorrheic for at least 12 consecutive months to be considered not of childbearing
        potential.

        9. Patient (male or female) of reproductive potential must agree to use medically
        acceptable contraception during the study. NOTE: Medically acceptable contraceptives
        include: (1) surgical sterilization, (2) approved hormonal contraceptives (such as birth
        control pills, Depo-Provera, or Lupron Depot), (3) barrier methods (such as a condom or
        diaphragm) used with a spermicide, or (4) an intrauterine device (IUD).

        10. Patient, or the patient's legally acceptable representative, must sign and date an
        informed consent PRIOR to registration and the performance of any study related procedures.

        11. Patient, or the patient's legally acceptable representative, must provide written
        authorization to allow the use and disclosure of their protected health information.

        - NOTE: This may be obtained in either the study-specific informed consent or in a separate
        authorization form and must be obtained from the patient prior to study registration.

        12. If patient is a cancer survivor, all of the following criteria must be met and
        documented in the patient's medical record:

          1. Patient has undergone potentially curative therapy for all prior malignancies.

          2. No evidence of prior malignancies for at least 5 years (except for successfully
             treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, or
             nonmelanoma skin cancer).

          3. No evidence of recurrence of any prior malignancy.

        Exclusion Criteria:

          1. Patient has pancreaticoduodenectomy histopathology of adenosquamous carcinoma,
             ampullary carcinoma, carcinoid tumor, cystadenocarcinoma, cystadenoma, distal common
             bile duct carcinoma, duodenal carcinoma, or islet cell carcinoma.

          2. Patient is pregnant or lactating.

          3. Patient has recurrent pancreatic cancer.

          4. Patient has received prior systemic chemotherapy or radiotherapy for pancreatic
             cancer.

          5. Patient has received external beam photon (x-ray) therapy to the chest, abdomen or
             pelvis.

          6. Patient has received any biologic/ immunologic therapies.

          7. Patient has received chronic immunotherapy (e.g. prednisone or methotrexate) for
             collagen vascular disease or other chronic immunologic abnormality.

          8. Patient has a preexisting psychiatric condition, especially depression, or a history
             of severe psychiatric disorders.