Neoadjuvant CAPOXIRI Chemotherapy in the Treatment of Resectable, Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma Protocol
This is a phase II study evaluating the treatment adherence rate, efficacy and safety of
neoadjuvant chemotherapy with capecitabine, oxaliplatin and irinotecan (CAPOXIRI) in
patients with resectable (able to be cut out), borderline resectable and locally advanced
pancreatic adenocarcinoma. Neoadjuvant CAPOXIRI chemotherapy is an innovative strategy that
builds on the advancement associated with oxaliplatin, irinotecan, fluorouracil, and
folinate (FOLFIRINOX regimen) chemotherapy in patients with metastatic disease. Building on
the FOLFIRINOX regimen the use of CAPOXIRI is among the most clinically relevant projects
for patients diagnosed with earlier stage pancreatic adenocarcinoma with the goal of
improving patient outcomes and advancing our knowledge and understanding of this devastating
The primary end point is the treatment adherence rate (TAR) which is the percentage of
patients who complete 75% of the planned treatment (dose) for their diagnostic strata
(resectable disease and borderline resectable/locally advanced disease).
Secondary end points are: Overall survival (OS), Disease-free survival (DFS; for those
patients who are rendered disease-free by surgical resection), Progression Free Survival
(PFS), Response Rate (RR), toxicity, and R0 resection rate (for patients stratified as
having resectable disease and borderline resectable disease).
Background and Study Rationale:
It is estimated that 36,800 people will die of pancreatic cancer in the United States in
2010. Surgical resection offers the only chance of cure, but only 15-20% of cases are
potentially resectable at present. Furthermore, prognosis is poor, even for those
undergoing complete resection. Reported five-year survival rates following
pancreatic-duodenectomy (surgery of the small intestine and pancreas) for node-negative
disease is 25-30% and for node-positive disease is 10%.
The purpose of this study is to evaluate the effects of the combination of capecitabine,
oxaliplatin, and irinotecan (CAPOXIRI) on the disease. This research is being done because
we think that this combination, CAPOXIRI, may be better than other combinations used to
treat your stage of pancreatic cancer.
A research study like this one has been done which shows that a similar combination of drugs
including oxaliplatin, irinotecan and 5-fluorouracil (which is in the same class as
capecitabine) can be effective in treating patients with pancreatic cancer who have more
advanced disease than you. All of the drugs that are being used in this study have been
approved by the FDA (Food and Drug Administration).
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
The primary end point is the treatment adherence rate (TAR) which is the percentage of patients who complete 75% of the planned treatment (dose) for their diagnostic strata (resectable disease and borderline resectable/locally advanced disease)
Adherence of subjects with treatment
Kevin Sullivan, MD
Beth Israel Medical Center
United States: Institutional Review Board
|St-Lukes Roosevelt Hospital Medical Center||New York, New York 10018|
|Beth Israel Comprehensive Care Center||New York, New York 10025|