Clinical trial NCT00260364 (phase 1/phase 2, status: completed)
Conditions: pancreatic cancer
ICD codes: C25.3
Drugs: gemcitabine 1000 mg/m2 iv days 1, 8, 15 of a 28 day cycle, capecitabine orally days 1 -21, erlotinib 100 mg orally days 1-28, bevacizumab 5 mg/kg intravenously every 2 weeks
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, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed adenocarcinoma of the pancreas

          -  Locally advanced or metastatic disease

          -  Not amenable to curative resection

          -  No invasion of adjacent organs (e.g., duodenum or stomach) by CT scan

          -  Unidimensionally measurable disease as assessed by CT in accordance with the Response
             Evaluation Criteria in Solid Tumors (RECIST) guidelines.

          -  No evidence of brain metastasis

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  Eastern Cooperative Oncology Group (ECOG) 0-2

        Life expectancy:

          -  Greater than 3 months

        Hematopoietic:

          -  Granulocyte count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic:

          -  Bilirubin ≤ upper limit of normal

          -  Serum albumin > 26 g/litre

        Renal:

          -  Creatinine ≤ 180 micromoles/litre OR

          -  Creatinine clearance ≥ 50 mL/min

        Cardiovascular:

          -  No clinically significant cardiovascular disease

          -  No uncontrolled hypertension (i.e., blood pressure > 150/90 mm Hg on medication)

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

               -  Myocardial infarction

               -  Unstable angina pectoris

               -  Cerebrovascular accident

               -  Transient ischemic attack

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

          -  No serious cardiac arrhythmia requiring medication

        OTHER:

          -  Not pregnant or breast feeding

          -  Fertile patients must use effective contraception during study participation

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

          -  No infection requiring parenteral antibiotics

          -  No major bleeding diathesis or coagulopathy

          -  No significant traumatic injury within the past 28 days

          -  No surgery within the last 28 days or anticipation for the need for major surgery
             during the course of study treatment

          -  No other active malignancy except non-melanoma skin cancer and cervical cancer in-situ

          -  No history of known dihydropyrimidine dehydrogenase (DPD) deficiency

          -  No lack of physical integrity of the upper gastro-intestinal tract, malabsorption
             syndrome, or inability to take oral medication

        PRIOR CONCURRENT THERAPY:

          -  No previous chemotherapy, radiotherapy or other investigational drug treatment for
             metastatic disease (including VEGF or EGFR antagonists)

          -  No previous preoperative or adjuvant chemotherapy, radiotherapy or other
             investigational drug treatment.

          -  No full dose anti-coagulation (i.e. warfarin or full dose low molecular weight
             heparin) prior to starting study treatment.

          -  No ongoing treatment with aspirin (>325 mg/day) or other medications known to
             predispose to gastrointestinal ulceration