Assessment Of Stromal Response To Nab-Paclitaxel In Combination With Gemcitabine In Pancreatic Cancer
Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
Summary
Targeting tumor stroma is emerging as a strategic approach for pancreatic cancer treatment.
Actually, one of the most interesting characteristics of pancreatic cancer is the dense
fibrotic stroma surrounding tumor cells. Moreover, pancreatic cancer stroma seems to express
a specific protein profile different from tumor cells. For example, secreted protein rich in
cysteine (SPARC) is overexpressed in pancreatic tumor stroma fibroblast and downregulated in
tumor cells. This characteristic is associated with poor clinical outcome.
Nab-paclitaxel, an albumin bound nano formulation of paclitaxel that targets SPARC, decreases
tumor stroma density. Such effect improves drug delivery, and enhances both, nab-paclitaxel
and gemcitabine, antitumor activity in nude mouse models.
Based on this pre-clinical data the investigators designed a clinical trial of nab-paclitaxel
in combination with gemcitabine as neo-adjuvant treatment for pancreatic cancer patients.
Fifteen, SPARC positive patients, will be enrolled in the study and treated with abraxane in
combination with gemcitabine.
This is a pilot study which primary end point is evaluating the effect of Abraxane in
combination with gemcitabine on tumor stroma, and the secondary end-point is correlating
these changing with treatment activity.