Clinical trial NCT00088894 (phase 3, status: completed)
Conditions: adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage ii pancreatic cancer, stage iii pancreatic cancer, stage iv pancreatic cancer
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C25.3, C25.3, C25.3, C25.3
Drugs: gemcitabine hydrochloride
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Eligibility criteria:

        Inclusion Criteria:

          -  Histologic or cytologic documentation of adenocarcinoma of the pancreas; documentation
             of disease extent by CT scan is required; radiologically measurable disease is not
             required; patients with documented invasion of adjacent organs (e.g., duodenum,
             stomach) by CT scan are not eligible

          -  No prior chemotherapy for metastatic disease

          -  If the patient received adjuvant therapy, it must have been completed at least 4 weeks
             prior to enrollment on this study; the patient must have recovered from all treatment
             related toxicities and must have evidence of disease progression following adjuvant
             treatment

          -  Prior radiation therapy, with or without a radiosensitizing dose of fluoropyrimidines,
             is allowed provided the patient has disease outside of the radiation port; at least 4
             weeks must have elapsed from completion of the radiation therapy and all signs of
             toxicity must have resolved

          -  No prior treatment with gemcitabine or bevacizumab in the adjuvant or metastatic
             setting

          -  No current or recent (within 1 month) use of a thrombolytic agent

          -  Patients may not have had prior therapy with other VEGF inhibitors

          -  No recent invasive surgical procedures; this includes:

               -  Major surgical procedure (e.g. exploratory laparotomy or laparoscopy), open
                  biopsy, or significant traumatic injury within 28 days prior to registration

               -  Fine needle aspirations or venous access device within 7 days prior to
                  registration

               -  Anticipation of need for major surgical procedures during the course of the study

          -  No clinically significant cardiovascular disease; this includes:

               -  Uncontrolled hypertension (blood pressure > 150/90 on medication)

               -  New York Heart Association grade II or greater congestive heart failure

               -  Serious cardiac arrhythmia requiring medication

          -  No recent (within 6 months) arterial thrombotic events, including transient ischemic
             attack (TIA), cerebrovascular accident (CVA), unstable angina, or myocardial
             infarction (MI); patients with clinically significant peripheral artery disease (i.e.,
             claudication on less than one block) are also ineligible

          -  No evidence of CNS disease, including primary brain tumor, or any brain metastasis

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

          -  No serious active infection (viral, fungal bacterial); no infection requiring
             parenteral antibiotics at time of registration

          -  Patients with known hypersensitivity of Chinese hamster ovary cell products or other
             recombinant human antibodies are not eligible

          -  Patients with a "currently active" second malignancy other than non-melanoma skin
             cancers are not to be registered; patients are not considered to have a "currently
             active" malignancy if they have completed therapy and considered by their physician to
             be at less than 30% risk of relapse

          -  Women must be non-pregnant and non-breast feeding

          -  ECOG Performance status of 0, 1 or 2

          -  Granulocytes ≥ 1,500/μl

          -  Platelet count ≥ 100,000/μl

          -  Creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min

          -  Total bilirubin ≤ 1 x upper limit of normal

          -  SGOT(AST) ≤ 2.5 x upper limit of normal

          -  PT INR =< 1.5, unless patient is on full dose warfarin

          -  Urine protein; for ≥ 1+ proteinuria, 24 hour urine collection must demonstrate < 1 gm
             of protein/24 hours

          -  Required diagnostic procedures:

               -  CT of the abdomen

               -  Chest x-ray