Metastatic Pancreatic Adenocarcinoma Clinical Trial
Official title:
Neoadjuvant CAPOXIRI Chemotherapy in the Treatment of Resectable, Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma Protocol
The combination of capecitabine, oxaliplatin, and irinotecan (CAPOXIRI) may be better than other combinations used to treat earlier stage pancreatic cancer patients with resectable (able to be cut out), borderline resectable, and locally advanced pancreatic adenocarcinoma. For subjects who can not obtain Capecitabine can be treated with 5-Fluorouracil (5-FU) along with Oxaliplatin and Irinotecan. Though all of the drugs in this study have been approved by the FDA, their combination is investigational. The purpose of this study is to evaluate the effects of CAPOXIRI (good and bad) on you and your cancer.
Introduction:
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 disease.
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).
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