Clinical trial NCT00100815 (phase 2, status: completed)
Conditions: pancreatic cancer
ICD codes: C25.3
Drugs: capecitabine, gemcitabine hydrochloride
SMILES: [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 confirmed adenocarcinoma of the pancreas meeting 1 of the following
             criteria:

               -  Newly diagnosed or previously treated metastatic disease

               -  Unresectable disease

          -  No CNS or brain metastases

        PATIENT CHARACTERISTICS:

        Age

          -  Over 18

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  More than 3 months

        Hematopoietic

          -  Absolute neutrophil count > 1,500/mm^3

          -  WBC > 3,000/mm^3

          -  Platelet count > 100,000/mm^3

          -  Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa allowed)

          -  No evidence of bleeding diathesis or coagulopathy

        Hepatic

          -  Bilirubin < 2 mg/dL

          -  AST or ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases
             are present)

          -  INR < 1.5 (except for patients receiving full-dose warfarin)

        Renal

          -  Creatinine < 1.5 mg/dL

          -  No proteinuria OR

          -  Urine protein < 500 mg by 24-hour urine collection

          -  No clinically significant impairment of renal function

        Cardiovascular

          -  No uncontrolled hypertension (blood pressure > 160/110 mm Hg on medication)

          -  No New York Heart Association class II-IV congestive heart failure

          -  No unstable symptomatic arrhythmia requiring medication

               -  Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal
                  supraventricular tachycardia) allowed

          -  No clinically significant grade II-IV peripheral vascular disease

          -  No arterial thromboembolic event within the past 6 months, including any of the
             following:

               -  Transient ischemic attack

               -  Cerebrovascular accident

               -  Unstable angina

               -  Myocardial infarction

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No other serious systemic disease

          -  No significant traumatic injury within the past 28 days

          -  No serious non-healing wound, ulcer, or bone fracture

          -  No history of other disease, metabolic dysfunction, physical examination finding, or
             clinical laboratory finding that would preclude study participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  Not specified

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  Not specified

        Surgery

          -  More than 28 days since prior major surgery or open biopsy

          -  More than 7 days since prior fine needle aspirations or core biopsies

          -  No concurrent major surgery

        Other

          -  More than 4 weeks since prior and no concurrent participation in any other
             experimental drug study

          -  More than 12 months since prior adjuvant therapy

          -  No prior systemic therapy for metastatic disease