Phase II Study of Neoadjuvant Gemcitabine and Abraxane Chemotherapy Followed by Surgery for Patients With Localized, Resectable, Adenocarcinoma of the Pancreas
- Patient has histologically or cytologically confirmed potentially resectable
adenocarcinoma of the pancreas. Patients with islet cell or other neuroendocrine
neoplasms are excluded.
- Definition of localized, potentially resectable disease:
- Staging by intravenous contrast-enhanced thin section helical abdominal computed
tomography (2.5 mm cuts or less) or MRI (for patients with an IV contrast allergy)
using pancreatic protocol. Endoscopic ultrasound is required for tissue acquisition
and staging confirmation.
- No extension to superior mesenteric artery (SMA) and hepatic artery. Patent superior
mesenteric vein/portal vein (SMV/PV) with < 180-degree abutment and no evidence of
- Clear fat plane between the SMA and celiac axis.
- No extension to celiac axis and hepatic artery.
- Patent superior mesenteric vein and portal vein.
- No evidence of distant disease.
- Male or non-pregnant and non-lactating female, and ≥ 18 years of age.
- If a female patient is of childbearing potential, she must have a negative serum
pregnancy test documented within 72 hours of the first administration of study drug.
- If sexually active, the patient must agree to use contraception considered adequate
and appropriate by the Investigator.
- Patient must not have received prior chemotherapy or radiation for pancreatic cancer.
- Patient has the following blood counts at baseline:
- ANC ≥ 1.5 x 109/L (1500 /mm³);
- Platelets ≥ 100 x 109/L; (100,000/mm³);
- Hgb ≥ 10 g/dL.
- Patient has the following blood chemistry levels at baseline:
- AST (SGOT), ALT (SGPT) ≤ 2.5 x upper limit of normal (ULN);
- Alkaline phosphatase (AP) ≤ 2.5 X ULN;
- Total bilirubin ≤ 2.0mg/dL.
- 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. For patients not receiving
anticoagulation: International Normalized Ratio of a measure of prothrombin time
(INR) < 1.3.
- Patient has an ECOG performance status PS 0-2.
- 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.
- Patient has borderline resectable, locally advanced unresectable or advanced
metastatic disease. Patients with adenocarcinoma of the pancreatic body or tail are
ineligible. Patients with endocrine tumors, lymphoma of the pancreas, or ampullary
cancer are also ineligible.
- Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring
- Patient has known infection with HIV.
- 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.
- Patient has a history of allergy or hypersensitivity to the study drugs.
- 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
chemotherapy and/or radiation therapy.
- Patients must not require chronic use of immunosuppressive agents (e.g. methotrexate,
- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
Stage I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been disease-free for five years.
- Patients must not have clinically significant cardiovascular disease (including
myocardial infarction, unstable angina, symptomatic congestive heart failure, serious
uncontrolled cardiac arrhythmia) < 1 year before randomization.
- Patient is unwilling or unable to comply with study procedures.
- Patient is enrolled in any other therapeutic clinical protocol or investigational
- Patients aged ≥ 80 are not excluded. However, candidates in this age group should be
thoroughly evaluated before enrollment in the study, to ensure they are fit to
receive chemotherapy, and to potentially undergo pancreaticoduodenectomy. 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 and
suitability to receive intensive 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