Pancreatic Cancer Clinical Trial
Official title:
A Phase II Study of the Combination of Fixed Dose Rate Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer
This is a phase II study of biweekly (every other week) bevacizumab followed by gemcitabine then infusional 5-fluorouracil in patients with stage III or IV pancreatic cancer. Patients' response will be evaluated every 8 weeks using usual CT scanning techniques. RECIST (Response Evaluation Criteria in Solid tumors) criteria will be applied to evaluate response. Tumor marker levels (Ca 19-9) will be assessed every 4 weeks, but will not be used to measure response.
Rationale: Research indicates that the vascular endothelial growth factor (VEGF), or a
substance made by cells that stimulates new blood vessel formation, plays an important role
in the growth and metastasis of many cancers, including pancreatic carcinoma. Both VEGF and
its receptors are overexpressed in pancreatic cancer. Bevacizumab works by blocking VEGF and
the growth of cancer cells in the process. The current study combines bevacizumab with two
commonly used pancreatic cancer drugs, gemcitabine and infusional 5-FU. Previous studies
indicate that bevacizumab combined with other anti-cancer drugs such as 5-FU improves
patient survival. In addition, other research suggests that the drug administration schedule
of the current study may improve patient outcomes compared to other types of administration
and sequencing.
Purpose: The primary objective of this study is to assess the rate of progression free
survival at 6 months in patients with advanced pancreatic cancer given gemcitabine,
infusional 5-FU, and bevacizumab. Secondary objectives of this study include measuring
response rates, 6 month and 1-year survival rates, and median overall survival.
Treatment: Study participants will be given bevacizumab, gemcitabine, and 5-FU. These drugs
will be administered through intravenous infusions in that order every other week on days 1
and 15. Treatments will be given in 28-day cycles. Participants will therefore receive study
drugs during weeks 1 and 3, and then receive no study drugs during weeks 2 and 4. Imaging
exams will be performed every 8 weeks to assess disease size. Several other tests will be
given throughout the study to closely monitor patients. Tumor level markers will be assessed
every 4 weeks, but will not be used to measure response. Study treatments will be
discontinued due to disease growth or severe adverse effects.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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