Pre-operative Treatment for Patients With Untreated Pancreatic Cancer

Korábbi kezelés

• 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.
• 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.

Más betegség

• Patient will be excluded from this study if any of the following criteria apply: Evidence of metastatic disease. No metastatic disease defined as any one or more of the following:
  • Suspicious lymphadenopathy outside of the standard surgical field (i.e. aortocaval nodes, distant abdominal nodes)
  • Radiographic evidence for metastatic disease in distant organs, peritoneum, or ascites
• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
• Known infection with HIV, hepatitis B, or hepatitis C.
• History of allergy or hypersensitivity to the study drugs.
• Current, serious, clinically significant cardiac arrhythmias as determined by the investigator.
• Patient with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.

Egyéb

• Patient is unwilling or unable to comply with study procedures.
• Patient is enrolled in any other therapeutic clinical protocol or investigational trial.
• Use of non-FDA approved cannabinoids are prohibited. Total daily usage of up to 40 mg per day of marinol is acceptable.

• Patient has histologically or cytologically confirmed resectable, borderline resectable, or locally advanced (unresectable) PDAC (based upon Tempero et al 2016)
  • Definition of Resectable Pancreatic Cancer includes all of the following:
  • No evidence of extra pancreatic disease
  • No evidence of tumor-arterial abutment (celiac, SMA \[superior mesenteric artery\] or HA \[hepatic artery\])
  • If tumor induced narrowing of the SMV \[superior mesenteric vein\], PV \[portal vein\] or SMV-PV \[superior mesenteric-portal vein\] confluence is present, it must be \<50% of the diameter of the vessel
  • Definition of Borderline Resectable Pancreatic Cancer
  • To include at least one of the following:
  • Tumor abutment \<180° of the SMA or celiac axis
  • Tumor abutment or encasement of a short segment of the HA
  • Tumor induced narrowing of SMV, PV or SMV-PV of \>50% of the diameter of the vessel.
  • Short segment occlusion of the SMV, PV or SMV-PV with a suitable PV above and SMV below, for reconstruction
  • Biopsy proven N1 disease (regional lymph nodes involved) from pre-referral biopsy or EUS-guided FNA
  • Definition of Locally Advanced (Unresectable)
  • Artery: Tumor encasement (\> 180°) of SMA or celiac artery
  • Vein Occlusion of SMV, PV or SMV-PV without suitable vessels above and below the tumor to allow for reconstruction (no distal or proximal target for vascular reconstruction)
  • No extra pancreatic disease: No evidence of peritoneal, hepatic, or extra-abdominal metastases
• Age ≥ 18 years.
• 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
• If sexually active, the patient and partner must agree to use contraception considered adequate and appropriate by the Investigator
• Patient must have received no prior chemotherapy or radiation therapy for PDAC
• Patients must have normal organ and marrow function as defined below:
  • absolute neutrophil count ≥ 1,500/mm3
  • platelets ≥ 100,000/mm3
  • Hematocrit level \> 27%
  • total bilirubin within institutional upper limit of normal (ULN)
  • AST/ALT ≤ 2.5 × institutional ULN
  • Alkaline phosphatase (AP) ≤ 2.5 x institutional ULN
  • Creatinine \< 1.5 mg/dl
• Patient has acceptable coagulation status as indicated by an INR ≤ 1.5 x ULN. Patients on anticoagulation can be included at the discretion of the investigator.
• Karnofsky Performance Status (KPS) of ≥70%.
• Have an elevated CA 19-9