Phase II Study of NGC-Triple Regimen in Potentially Resectable Pancreatic Cancer Patients
Phase II Study of NGC-Triple Regimen in Potentially Resectable Pancreatic Cancer Patients
This is a phase II multi-center study of nab-paclitaxel, gemcitabine and cisplatin (NGC
 triple regimen) as preoperative therapy in potentially resectable pancreatic cancer patients.

 DISEASE STATE

 -  Potentially operable or borderline resectable pancreatic adenocarcinoma as assessed by
 standard CT criteria and histologically confirmed.

 -  Staging by pancreatic protocol, helical abdominal computed tomography (with contrast) or
 MRI (with contrast) required (endoscopic ultrasound is not required).

 -  No evidence of metastatic disease. Lymphadenopathy (defined as nodes measuring >1 cm in
 short axis) outside the surgical basin (i.e., para-aortic, peri-caval, celiac axis, or
 distant nodes) is considered M1 (unless nodes are biopsied and are negative, then
 enrollment can be considered after review with the study PI).

 Potentially Resectable Pancreatic Cancer

 -  No involvement of the celiac artery, common hepatic artery, and superior mesenteric
 artery (SMA) and, if present, replaced right hepatic artery.

 -  No involvement or <180° interface between tumor and vessel wall of the portal vein
 and/or superior mesenteric vein (SMV-PV) and patent portal vein/splenic vein confluence.

 -  For tumors of the body and tail of the pancreas, involvement of the splenic artery and
 vein of any degree is considered resectable disease. Borderline Resectable Pancreatic
 Cancer

 -  Tumor-vessel interface ≥180° of vessel wall circumference, and/or reconstructible
 occlusion of the SMV-PV.

 -  Tumor-vessel interface <180° of the circumference of the SMA.

 -  Tumor-vessel interface <180° of the circumference of the celiac artery.

 -  Reconstructible short-segment interface of any degree between tumor and hepatic artery.
The purpose of this study is to find out if the study drugs nab-paclitaxel, cisplatin, and
 gemcitabine given together are safe and effective. The combination of nab-paclitaxel plus
 gemcitabine has been studied in treating patients with pancreatic cancer, and as of
 September, 2013 is approved for the treatment of advanced pancreatic cancer. In this study,
 cisplatin will be added to nab-paclitaxel plus gemcitabine, and tested in people who have not
 yet had any cancer therapy for the diagnosis of localized pancreatic cancer, as treatment
 prior to surgery, with the goal of improving response.

 Another name for nab-paclitaxel is Abraxane®. Nab-paclitaxel contains the same medication as
 the prescription chemotherapy drug Abraxane®. Nab-paclitaxel is approved by the FDA for the
 treatment of advanced breast cancer, and in September, 2013 nab-paclitaxel, combined with
 gemcitabine, was approved by the FDA for the treatment of advanced pancreatic cancer.

 Cisplatin is approved by the FDA for the treatment of advanced bladder cancer, advanced
 ovarian cancer, and advanced testicular cancer and other childhood cancers. However,
 cisplatin is not approved by the FDA for the treatment of advanced pancreatic cancer.

 Gemcitabine was approved by the FDA in 1996 for the treatment of pancreatic cancer. It is
 also an approved treatment for ovarian cancer, lung cancer, and breast cancer.

 Nab-paclitaxel, cisplatin, and gemcitabine will be given weekly for 2 weeks followed by a
 week of rest, for a total of 3 cycles. A cycle is defined as one set of 3 weeks of
 chemotherapy treatment. Patients will undergo surgery after a minimum of 3 weeks after Cycle
 3 of chemotherapy. Following surgery, patients mayl be treated for up to 3 cycles of this
 same chemotherapy combination.
Major Inclusion Criteria for the Study Include the Following:

 -  Patient has an ECOG performance status PS 0-1. No prior chemotherapy or radiation for
 pancreatic cancer and no prior exposure to gemcitabine and/or nab-paclitaxel

 Patient has the following blood counts at baseline:

 -  ANC ≥1.5 × 109/L (1500 /mm3)

 -  Platelets ≥100 × 109/L; (100,000/mm3)

 -  Hgb ≥10 g/dL

 Patient has the following blood chemistry levels at baseline:

 -  AST (SGOT), ALT (SGPT) ≤ 3.0 × upper limit of normal (ULN)

 -  Alkaline phosphatase (AP) ≤3.0 X ULN

 -  Total bilirubin ≤1.5 or ≤ULN

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

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

 Major Exclusion Criteria include the Following:

 1. Patient has locally advanced unresectable pancreatic cancer.

 2. Patients aged >75.

 3. Histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible.

 4. Patient uses therapeutic Coumadin for a history of pulmonary emboli or DVT.

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

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

 7. 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.

 8. Prior chemotherapy or radiation for pancreatic cancer. Prior exposure to gemcitabine
 and/or nab-paclitaxel.

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

 -

 -