Gemcitabine, Bevacizumab, and Abdominal Radiation Therapy in Treating Patients With Localized Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some
      block the ability of tumor cells to grow and spread. Others find tumor cells and help kill
      them or carry tumor-killing substances to them. Bevacizumab may also stop the tumor growth by
      blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor
      cells. Gemcitabine and bevacizumab may make tumor cells more sensitive to radiation therapy.
      Giving gemcitabine together with bevacizumab and radiation therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving gemcitabine together with
      bevacizumab and abdominal radiation therapy works in treating patients with localized
      pancreatic cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the objective response rate in patients treated with concurrent bevacizumab,
           gemcitabine hydrochloride, and abdominal radiotherapy.

      Secondary

        -  Determine the quantitative toxicity associated with the delivery of this regimen in
           these patients.

        -  Determine the 1-year and median survival of patients treated with this regimen.

        -  Determine the time to progression in patients treated with this regimen.

        -  Determine the patterns of recurrence in the entire population of patients treated with
           this regimen and in the subgroup that is resected for cure.

        -  Determine the safety of this regimen in these patients.

        -  Evaluate the surgical experience of patients who undergo surgical resection after
           completion of protocol-directed therapy.

        -  Evaluate the toxicity associated with surgical resection in these patients.

      OUTLINE: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 of
      courses 1 and 3 and on days 1, 8, and 15 of course 2. Patients also receive bevacizumab IV
      over 30-90 minutes on days 1 and 15 of course 1, on days 8 and 22 of course 2, and on day 8
      of course 3. Treatment repeats every 3-4 weeks for up to 3 courses in the absence of disease
      progression or unacceptable toxicity. Beginning on day 1 of the second course of
      chemotherapy, patients undergo concurrent abdominal radiotherapy once daily, five days a
      week, for 3 weeks.

      Patients are evaluated at week 10. Patients whose disease deemed resectable after study
      treatment undergo standard pancreatic resection at least 6 weeks after completion of
      bevacizumab. Patients who remain unresectable and have not progressed after completion of
      chemoradiotherapy may begin maintenance therapy comprising gemcitabine hydrochloride IV over
      30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15.
      Treatment with gemcitabine hydrochloride and bevacizumab repeats every 4 weeks in the absence
      of disease progression or unacceptable toxicity.

      After completion of study therapy, patients are followed periodically for up to 10 years.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
    

Intervention name(s): bevacizumab; gemcitabine; conventional surgery; radiation therapy
Intervention type(s): Biological; Drug; Procedure; Radiation
Intervention description(s): 10 mg/kg every 2 weeks as an intravenous infusion after gemcitabine and before radiation; 1000 mg/m2, 30 minute intravenous infusion, cycle 1 (weeks 1, 2), cycle 2 (weeks 4, 5, 6) and cycle 3 (weeks 8 and 9). During cycle 2, gemcitabine will be delivered prior to radiation therapy; If resectable, patients will undergo surgery no less than 6 weeks following last dose of bevacizumab. Unresectable patients will not undergo surgery.; 2.4 Gy fractions, 5 fractions/week during cycle 2 only (weeks 4, 5, 6). Total dose 36 Gy.
Other intervention name(s): Avastin; gemcitabine hydrochloride
Intervention MeSH terms: Bevacizumab; Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I pancreatic cancer; stage II pancreatic cancer; stage III pancreatic cancer