A Phase II Study of Induction Consolidation and Maintenance Approach for Patients With Advanced Pancreatic Cancer
The investigators in the PCRT team have developed a therapeutic regimen which attacks both
the tumor compartment and the stromal compartment of pancreatic cancer and induces complete
responses in a small percentage of patients with advanced stage IV pancreatic cancer.
The gemcitabine + nab-paclitaxel regimen had outstanding activity in a 67 patient phase I/II
trial with all patients at the recommended phase II doses (n=44) having a decrease in
CA19-9, some complete responses and a median survival of 12.2 months. The proposed regimen
that is devised for this study is a bold, innovative approach with the specific aim of
utilizing a relentless pursuit approach to try to make the complete response rate >70% and
have this response be durable (which the PCRT has defined as lasting at least 6 months) and
to dramatically enhance the percent of patients who survive one year (try to make the rate
The induction regimen the investigators propose collapses the stroma (gemcitabine +
nab-paclitaxel) and addresses the use of a non-cross resistant active regimen (FOLFIRINOX)
as a consolidation regimen. Both should improve the chance of driving tumor markers down
dramatically. The investigators think that FOLFIRINOX with the stromal collapse induced by
the initial regimen, plus the totally non-cross resistant shot against the disease
(consolidation), will maximize the chance of achieving a complete response with an attendant
improvement in survival.
After the consolidation, the patient will be maintained on a less toxic targeted therapy
selected by molecular profiling plus the use of the antimetabolomic agent metformin which
has consistently been associated with better survival in multiple retrospective studies
(Jiralerspong et al., 2009).
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete Response Rate
The primary objectives of this study are to relentlessly pursue treatment for 34 individual patients with Stage IV pancreatic cancer to obtain: • The complete response rate (as defined by a complete metabolomic response (CMR) of SUV normalization from baseline, OR a complete response on CT scan using a modified RECIST criteria and CA 19-9 (or CA 125, CEA, or PAM4 if not expressers of CA 19-9) down to normal limits (from at least > 2X ULN).
Ramesh K Ramanathan, MD
Translational Genomics Research Institute, Phoenix, Arizona.
United States: Institutional Review Board
|Virginia Mason Medical Center||Seattle, Washington 98111|
|Evergreen Hematology And Oncology||Spokane, Washington 99218|
|Disney Family Cancer Center||Burbank, California 91505|
|TGen Clinical Research Services (TCRS)||Scottsdale, Arizona 85258|
|Virginia Piper Cancer Institute (VPCI)||Minneapolis, Minnesota 55407|