Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
In Brazil pancreatic adenocarcinoma represents 2% of tumors, and 4% mortality being an
uncommon disease, however very aggressive.Only 20% of cases are indicated for curative
surgery, of which only 20% are alive within 5 years. For locally, advanced or metastatic
disease, since 1997, single chemotherapy with gemcitabine is the standard treatment for first
line, with survival around 6 months approximately.There is no standard treatment regimen for
second-line, however Paclitaxel demonstrated effect on second-line phase II study. Metformin
is an oral hypoglycemic drug used for treatment of diabetes mellitus. There is a growing
number of preclinical studies which show antitumor effect against pancreatic adenocarcinoma,
probably due to the effect of anti-insulin growth factor (IGF-1). This study will add
metformin to standard treatment for second line of locally advanced or metastatic pancreatic
adenocarcinoma in ICESP previously treated with gemcitabine. The objective is to evaluate
whether metformin improves the efficacy of the standard treatment with paclitaxel by clinical
and radiological evaluation.