A Pilot Study of Pre- and Post-surgery Chemotherapy With mFOLFIRINOX in Localized, Resectable Pancreatic Adenocarcinoma

• Status: Completed
• Trial end date: 2018-08-22
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to demonstrate that it is possible to administer chemotherapy prior to and following surgery for pancreatic cancer which is considered operable. The chemotherapy chosen is that which has been shown to be the most effective in treating metastatic disease, and the goal is both to investigate whether this is tolerable and also to investigate the efficacy of this approach in terms of disease response and survival.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NorthShore University HealthSystem
• Collaborator: University of Chicago
• Treatments: Fluorouracil; Irinotecan; Leucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologic or cytologic diagnosis of adenocarcinoma of the pancreas.

• Resectable primary tumor of the head, body or tail of the pancreas defined as a visible mass in the pancreas and:

• No extrapancreatic disease

• A patent superior mesenteric (SMV)- portal vein (PV) confluence (assuming the technical ability to resect and reconstruct this venous confluence if needed)

• A definable tissue plane between the tumor and regional arterial structures including the celiac axis, common hepatic artery, and SMA.

• Confirmation of resectability by surgical oncology consultation.

• Presentation at a multidisciplinary conference at either University of Chicago or NorthShore University

• No previous therapy for pancreatic cancer

• Short removable metal stents rather than plastic stents are preferred but not required for palliation of initial obstructive jaundice

• Karnofsky performance status 80 or better

• Age > 21 years

• No currently active second malignancy

• No CVA within 6 months, no MI within 6 months

• The effects of mFOLFIRINOX on the developing human fetus are unknown. For this reason and because chemotherapy agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.

• Negative pregnancy test in females of reproductive age

• Life expectancy of greater than 3 months.

• Anticoagulation is permitted but patients may only be on lovenox for this purpose.

• Patients must have normal organ and marrow function as defined below:

• absolute neutrophil count >1,500/mcL

• platelets >100,000/mcL

• total bilirubin <1.5X upper limits of normal

• AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal

• creatinine within normal institutional limits OR

• creatinine clearance >60 mL/min/ per Cockcroft-Gault equation for patients with creatinine levels above institutional normal.

• Ability to understand and the willingness to sign a written informed consent document.

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.

• History of allergic reactions attributed to 5FU, 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 FOLFIRINOX, 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.

• Currently active second malignancy other than non-melanoma skin cancer or carcinoma in-situ of the cervix. Patients are not considered to have a "currently active" malignancy if they have completed therapy and have no evidence of recurrence for at least 5 years.

• Pre-existing neuropathy greater than grade 1.

• Anticoagulants other than low molecular weight heparin.