A Randomized Phase III Trial Of Gemcitabine Plus Bevacizumab (NSC#704865 IND#7621) Versus Gemcitabine Plus Placebo In Patients With Advanced Pancreatic Cancer

Date de début de l'étude : 1 juin 2004

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