Neoadjuvant CAPOXIRI Chemotherapy in the Treatment of Pancreatic Adenocarcinoma Protocol
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|ClinicalTrials.gov Identifier: NCT01760252|
Recruitment Status : Terminated
First Posted : January 4, 2013
Last Update Posted : March 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Adenocarcinoma||Drug: Capecitabine, Oxaliplatin and Irinotecan (CAPOXIRI)||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant CAPOXIRI Chemotherapy in the Treatment of Resectable, Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma Protocol|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||February 21, 2018|
|Actual Study Completion Date :||February 21, 2018|
Experimental: CAPOXIRI Chemotherapy Regimen
Capecitabine, Oxaliplatin and Irinotecan (CAPOXIRI)
The proposed chemotherapy regimen CAPOXIRI is:
Drug: Capecitabine, Oxaliplatin and Irinotecan (CAPOXIRI)
Neoadjuvant CAPOXIRI chemotherapy is an innovative strategy that builds on the advancement associated with FOLFIRINOX chemotherapy in patients with metastatic 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) [ Time Frame: 5 years ]Adherence of subjects with treatment
- Overall survival (OS), [ Time Frame: 5 years ]
- Progression Free Survival (PFS), [ Time Frame: 5 years ]
- Response Rate (RR), [ Time Frame: 1 year ]
- R0 resection rate for patients stratified as having resectable disease and borderline resectable disease. [ Time Frame: 5 years ]
- Disease-free survival (DFS; for those patients who are rendered disease-free by surgical resection), [ Time Frame: 5 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760252
|United States, New York|
|Mount Sinai Beth Israel|
|New York, New York, United States, 10003|
|St-Lukes Roosevelt Hospital Medical Center|
|New York, New York, United States, 10018|
|Beth Israel Comprehensive Care Center|
|New York, New York, United States, 10025|
|Principal Investigator:||Peter Kozuch, MD||Beth Israel Medical Center|