Clinical trial NCT00262951 (phase 2, status: terminated)
Conditions: pancreatic cancer
ICD codes: C25.3
Drugs: cisplatin, 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, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    closed at a planned interim analysis by meeting a predefined toxicity endpoint
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patient must have newly diagnosed computated tomography (CT) and endoscopic
             ultrasound(EUS) stage Tx-4, N0-1, M0 adenocarcinoma of pancreas according to the
             American Joint Committee on Cancer (AJCC) staging system. The following cell types
             will NOT be eligible: adenosquamous carcinoma, ampullary carcinoma, carcinoid tumor,
             cystadenocarcinoma, cystadenoma, distal common bile duct carcinoma, duodenal
             carcinoma, or islet cell carcinoma

          -  Treatment must begin within 60 days of diagnosis

          -  Must have locally advanced inoperable pancreatic cancer with no metastatic spread as
             determined by a baseline diagnostic CT scan of the chest, endoscopic ultrasound and CT
             scan with intravenous (IV) contrast (or MRI) of abdomen/pelvis, within 30 days prior
             to registration.

          -  No prior systemic chemotherapy or radiation therapy for pancreatic cancer

          -  Documented Eastern Cooperative Oncology Group (ECOG/Zubrod) performance status 0-1
             within 14 days prior to registration

          -  Adequate hematologic, renal and hepatic function as defined by the following
             laboratory values (completed within 14 days prior to registration)

               -  white blood cell (WBC) > 3,000 mm3

               -  absolute neutrophil count (ANC) > 1,500 mm3

               -  platelet count ≥ 100,000 mm3

               -  hemoglobin > 9.5 g/dl

               -  serum creatinine < 1.5 times institutional upper limit of normal (ULN)

               -  total bilirubin ≤ 3 mg/dl

               -  AST (SGOT) < 4.0 times institutional ULN

               -  ALT (SGPT) < 4.0 times institutional ULN

               -  alkaline phosphatase < 2.0 times institutional ULN

          -  Age ≥ 18 years

          -  Life expectancy ≥ 12 weeks

          -  Patient (male or female) of reproductive potential are required to use a medically
             acceptable contraception during treatment and for 3 months after the last dose of
             chemotherapy.

          -  Not pregnant or breastfeeding since the drugs used in this study are Pregnancy
             Category D: Clear evidence of risk in pregnancy. A negative pregnancy test is required
             within 7 days of registration if pre- or perimenopausal (i.e., last menstrual period
             within one year of registration)

          -  If patient has a previous diagnosis of cancer, all of the following criteria must be
             met and documented in the patient's medical record:

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

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

               -  No evidence of recurrence of any prior malignancy.

          -  Patient who is receiving chronic immunotherapy (e.g. prednisone or methotrexate) for
             collagen vascular disease or other chronic immunologic abnormality are not eligible.

          -  Not requiring one or more of the contraindicated medications

          -  Patient must be able to understand the potential risks and benefits associated with
             this study. Patient able to give informed consent and would likely to comply with the
             study parameters.