Clinical trial NCT02782182 (phase 1, status: terminated)
Conditions: pancreatic ductal adenocarcinoma (pdac)
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: folfirinox (oxaliplatin, leucovorin, irinotecan)
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    closed early due to poor accrual.
  
Eligibility criteria:

        Inclusion Criteria

          1. Histologic or cytologic diagnosis of adenocarcinoma of the pancreas.

          2. Resectable primary tumor of the head, body or tail of the pancreas defined per NCCN
             Guidelines version 2.2015:

               -  No extra-pancreatic disease, aside from lymphadenopathy

               -  No arterial tumor contact (celiac axis, superior mesenteric artery, or common
                  hepatic artery)

               -  No tumor contact with the superior mesenteric vein or portal vein or ≤ 180°
                  contact without vein contour irregularity

          3. Confirmation of resectability by surgical oncology consultation.

          4. No previous therapy for pancreatic cancer

          5. Short removable metal stents rather than plastic stents are strongly encouraged but
             not required for palliation of initial obstructive jaundice

          6. ECOG performance status of 0 or 1 (Appendix 1)

          7. Age > 18 years

          8. No CVA within 6 months, no MI within 6 months

          9. 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.

         10. Negative pregnancy test in females of reproductive age

         11. Anticoagulation is permitted but patients may not be on warfarin.

         12. 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 Cockroft-Gault equation for patients with
                  creatinine levels above institutional normal.

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

        Exclusion Criteria:

          1. Patients who have had previous chemotherapy or radiotherapy for pancreatic
             adenocarcinoma prior to entering the study.

          2. Pathologic subtypes other than pure adenocarcinoma; acinar cell carcinoma, squamous
             cell carcinoma, spindle cell carcinoma, neuroendocrine cancer, and mixed types are not
             eligible.

          3. Patients who are receiving any investigational agents.

          4. Patients with borderline resectable, locally advanced or metastatic disease.

          5. History of allergic reactions attributed to 5-FU, leucovorin, irinotecan or
             oxaliplatin or to compounds of similar chemical or biologic composition.

          6. 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.

          7. 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.

          8. 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.

          9. 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.

         10. Pre-existing neuropathy greater than grade 1.

         11. Inflammatory bowel disease that is uncontrolled or on active treatment (Crohn's
             disease, ulcerative colitis).