Gemcitabine With Abraxane and Other Investigational Therapies in Neoadjuvant Treatment of Pancreatic Adenocarcinoma
Condition: Pancreatic Cancer
MeSH terms: Adenocarcinoma
Intervention: Chemotherapy; Chemotherapy + ChemoRadiotherapy
Intervention description: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.; Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
Intervention MeSH terms: Gemcitabine; Albumin-Bound Paclitaxel; Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      This study will evaluate the role of Gemcitabine and Abraxane in the treatment of resectable
      and borderline-resectable pancreatic cancer by giving the chemotherapy before surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  • Histologically or cytologically confirmed adenocarcinoma of the pancreas.

               -  Patients must have locally advanced pancreatic cancer, classified as either
                  low-risk resectable (LR), high-risk resectable (HR) or borderline resectable (BR)

               -  Age between 18 and 90 years at the time of consent.

               -  Patients with biliary obstruction must have adequate drainage prior to starting
                  treatment.

               -  Patients must have ≤ Grade I peripheral neuropathy (CTCAE v 4.0)

               -  Patients must have ≤ ECOG Performance status 2

               -  Pretreatment laboratory parameters:

                    -  Absolute granulocyte/neutrophil count (AGC/ANC) ≥ 1.8 thou/mm3

                    -  Platelet count ≥ 100,000/mm3

                    -  Bilirubin < 2 mg/dl

                    -  ALT/SGPT < 10x upper limit of normal

                    -  Creatinine < 3 mg/dl

                    -  Calculated creatinine clearance (via Cockcroft-Gault) > 30 mL/min

                    -  Baseline CA 19-9 levels

               -  Signed study specific, IRB stamped informed consent

        Exclusion Criteria:

          -  • Evidence of any distant metastasis including peritoneal seeding and/or malignant
             ascites

               -  Previous irradiation to the abdomen that would compromise the ability to deliver
                  the prescribed treatment

               -  Prior treatment for pancreatic cancer

               -  Active, untreated infection

               -  Surgical resection of the tumor (not including biopsies)

               -  Other malignancy (except non-melanoma skin cancer) that has not been disease-free
                  for at least 5 years.

               -  Pregnant and/or breast-feeding women, or patients (men and women) of
                  child-producing potential not willing to use medically acceptable contraception
                  while on treatment and for at least 3 months thereafter.

               -  Use of anti-epileptics (drugs such as phenytoin, phenobarbitol and carbamazepine)

               -  ECG abnormality with the following: QTC >500, left bundle branch block or any
                  other clinically significant finding that would interfere with protocol therapy.

               -  History of any other disease, metabolic dysfunction, physical examination
                  finding, or clinical laboratory finding giving reasonable suspicion of a disease
                  or condition that contraindicates the use of protocol therapy or that might
                  affect the interpretation of the results of the study or that puts the subject at
                  high risk for treatment complications, in the opinion of the treating physician