Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Metastatic or Unresectable Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: bevacizumab; capecitabine; gemcitabine hydrochloride
Intervention description: 30-90 minutes on day 1, every 21 days up to 12 months.; twice daily on days 1-14. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.; IV over 30 minutes on days 1 and 8. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Intervention MeSH terms: Bevacizumab; Gemcitabine; Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the pancreas; recurrent pancreatic cancer; stage IV pancreatic cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Bevacizumab may stop the growth of tumor cells by stopping blood flow to
      the tumor. Giving gemcitabine and capecitabine together with bevacizumab may kill more tumor
      cells.

      PURPOSE: This phase II trial is studying how well giving gemcitabine and capecitabine
      together with bevacizumab works in treating patients with metastatic or unresectable
      pancreatic cancer.
    

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