Multicenter, Open Label, Phase II Clinical Study of Gemcitabine, Capecitabine and Avastin in Pancreatic Cancer
- Determine progression-free survival of patients with metastatic or unresectable
adenocarcinoma of the pancreas treated with gemcitabine, capecitabine, and bevacizumab.
- Determine clinical response in patients treated with this regimen.
- Determine toxicity of this regimen in these patients.
- Determine quality of life of patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1, oral capecitabine twice daily
on days 1-14, and gemcitabine 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.
Quality of life is assessed at baseline then weekly for 3 weeks.
Patients are followed every 2-4 months for 1 year and then every 6 months for at least 5
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within 8.8-17.5
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
every 2-4 months for 1 year and then every 6 months for at least 5 years
Renuka Iyer, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|