Bevacizumab and Erlotinib in Treating Patients With Metastatic Pancreatic Cancer That Did Not Respond to Previous Treatment With Gemcitabine
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: 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
      growth of pancreatic cancer by blocking blood flow to the tumor. Erlotinib may stop the
      growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving
      bevacizumab together with erlotinib may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving bevacizumab together with erlotinib
      works in treating patients with metastatic pancreatic cancer that did not respond to previous
      treatment with gemcitabine.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Evaluate the 6-month overall survival rate in patients with gemcitabine
           hydrochloride-refractory metastatic pancreatic cancer treated with bevacizumab and
           erlotinib hydrochloride.

        -  Determine the safety and toxicity of this regimen in these patients.

      Secondary

        -  Evaluate the objective response rate in these patients.

        -  Evaluate time to tumor progression in these patients.

        -  Determine the efficacy of this regimen, in terms of the proportion of patients with ≥
           50% decline in carbohydrate antigen 19-9, also called cancer antigen 19-9 (CA19-9)
           biomarker, in these patients.

        -  Obtain sequential measurements of circulating tumor cells (micrometastases) and
           endothelial cells in serum and correlate these variables with clinical outcomes (in
           patients enrolled in UCSF site only).

      OUTLINE: This is an open-label, nonrandomized, multicenter study.

      Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib hydrochloride
      once daily on days 1-21. Treatment repeats every 21 days in the absence of disease
      progression or unacceptable toxicity.

      Patients undergo blood collection at baseline and periodically during study for
      biomarker/laboratory analysis, including the CA19-9 biomarker. Circulating tumor
      micrometastases and endothelial cells are also measured in patients enrolled in University of
      California San Francisco (UCSF) site.

      After completion of study treatment, patients are followed at 30 days and at 6 months.

      PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
    

Intervention name(s): bevacizumab; erlotinib hydrochloride; laboratory biomarker analysis
Intervention type(s): Biological; Drug; Other
Intervention MeSH terms: Bevacizumab; Erlotinib Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV pancreatic cancer; adenocarcinoma of the pancreas; recurrent pancreatic cancer