Clinical trial NCT01298011 (phase 2, status: completed)
Conditions: resectable pancreatic cancer
ICD codes: C25.3
Drugs: gemcitabine and abraxane
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Eligibility criteria:

        Inclusion Criteria:

          1. Patient has histologically or cytologically confirmed potentially resectable
             adenocarcinoma of the pancreas. Patients with islet cell neoplasms are excluded.

             Definition of potentially operable disease

               1. Staging by high-quality, pancreatic protocol, helical abdominal computed
                  tomography required (Endoscopic ultrasound is not required).

               2. No extension to superior mesenteric artery (SMA) and hepatic artery.

               3. Clear fat plane between the SMA and celiac axis.

               4. No extension to celiac axis and hepatic artery.

               5. Patent superior mesenteric vein and portal vein.

               6. No evidence of distant or extra-hepatic disease by CT scans.

               7. Pretreatment histological or cytological confirmation of an adenocarcinoma.

          2. Male or non-pregnant and non-lactating female, and ≥ 18 years of age.

          3. If a female patient is of child-bearing potential, she must have a negative serum
             pregnancy test (β hCG) documented within 72 hours of the first administration of study
             drug.

          4. If sexually active, the patient must agree to use contraception considered adequate
             and appropriate by the Investigator.

          5. Patient must have received no prior chemotherapy or radiation for pancreatic cancer
             and no exposure to gemcitabine and/or Abraxane

          6. Patient has the following blood counts at baseline:

               1. ANC ≥ 1.5 x 109/L (1500 /mm³);

               2. Platelets ≥ 100 x 109/L; (100,000/mm³);

               3. Hgb ≥ 10 g/dL.

          7. Patient has the following blood chemistry levels at baseline:

               1. AST (SGOT), ALT (SGPT) ≤ 2.5 x upper limit of normal (ULN);

               2. Alkaline phosphatase (AP) ≤ 2.5 X ULN;

               3. Total bilirubin ≤1.5 mg/dl;

               4. Serum creatinine ≤1.5mg/dl or calculated clearance ≥ 50 mL/min/1.73 m² for
                  patients with serum creatinine levels >1.5 mg/dl.

          8. Patient has acceptable coagulation status as indicated by a PT within normal limits
             (±15%) and PTT within normal limits (± 15%).

          9. Patient has an ECOG performance status PS 0-1.

         10. Patient has been informed about the nature of the study, and has agreed to participate
             in the study, and signed the Informed Consent Form prior to participation in any
             study-related activities.

        Exclusion Criteria:

          1. Patient has borderline resectable disease

          2. Patient uses therapeutic coumadin for a history of pulmonary emboli or DVT.

          3. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring
             systemic therapy.

          4. Patient has known infection with HIV, hepatitis B, or hepatitis C.

          5. Patient has undergone major surgery, other than diagnostic surgery (i.e.--surgery done
             to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to
             Day 1 of treatment in this study.

          6. Prior chemotherapy or radiation for pancreatic cancer. Prior exposure to gemcitabine
             and/or Abraxane.

          7. Patient has a history of allergy or hypersensitivity to the study drugs.

          8. Patient has serious medical risk factors involving any of the major organ systems such
             that the Investigator considers it unsafe for the patient to receive an experimental
             research drug.

          9. Patient is unwilling or unable to comply with study procedures.

         10. Patient is enrolled in any other therapeutic clinical protocol or investigational
             trial.

         11. Patient has metastatic disease on radiological staging.

         12. Patients aged ≥ 80 are not excluded. As two events of fatal sepsis have been seen in
             this group in other studies, candidates in this age group should be thoroughly
             evaluated before enrollment in the study, to ensure they are fit to receive
             chemotherapy. In addition to meeting all of the baseline patient selection criteria,
             clinical judgment on their susceptibility to infection and expected stability of their
             performance status as to receive repeat weekly chemotherapy cycles, should be paid
             special attention to. Patients should not be enrolled in the study should there be any
             hesitation on any of these considerations. Baseline criteria for all patients enrolled
             on the study must be carefully evaluated and all criteria followed appropriately.