Perioperative FOLFIRINOX for Patients With Resectable Pancreatic Adenocarcinoma: A Pilot Study (NCT02782182) | Clinical Trial Compass
TerminatedPhase 1
Perioperative FOLFIRINOX for Patients With Resectable Pancreatic Adenocarcinoma: A Pilot Study
Stopped: Closed early due to poor accrual.
United States1 participantsStarted 2016-06-28
Plain-language summary
The purpose of this study is to see whether it is possible to give 8 doses of a combination of chemotherapy called FOLFIRINOX before surgery in subjects whose pancreas cancer can be removed with surgery.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologic or cytologic diagnosis of adenocarcinoma of the pancreas.
✓. Resectable primary tumor of the head, body or tail of the pancreas defined per NCCN Guidelines version 2.2015:
✓. Confirmation of resectability by surgical oncology consultation.
✓. No previous therapy for pancreatic cancer
✓. Short removable metal stents rather than plastic stents are strongly encouraged but not required for palliation of initial obstructive jaundice
✓. ECOG performance status of 0 or 1 (Appendix 1)
✓. Age \> 18 years
✓. No CVA within 6 months, no MI within 6 months
Exclusion criteria
✕. Patients who have had previous chemotherapy or radiotherapy for pancreatic adenocarcinoma prior to entering the study.
✕. Pathologic subtypes other than pure adenocarcinoma; acinar cell carcinoma, squamous cell carcinoma, spindle cell carcinoma, neuroendocrine cancer, and mixed types are not eligible.
✕. Patients who are receiving any investigational agents.
✕. Patients with borderline resectable, locally advanced or metastatic disease.
✕
What they're measuring
1
Percentage of patients able to complete 4 months of preoperative chemotherapy and undergo a resection
. History of allergic reactions attributed to 5-FU, leucovorin, irinotecan or oxaliplatin or to compounds of similar chemical or biologic composition.
✕. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active liver disease including viral or non-viral hepatitis and cirrhosis, chronic diarrhea or inflammatory disease of the colon or rectum, or psychiatric illness/social situations that would limit compliance with study requirements.
✕. Pregnant women are excluded from this study. mFOLFIRINOX is a regimen containing more than one chemotherapy agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with mFOLFIRINOX, breastfeeding should be discontinued if the mother is treated with these agents. These potential risks may also apply to other agents used in this study.
✕. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with mFOLFIRINOX. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.