Yale Pancreatic Study

Study #IRB111201

Condition / Intervention

Pancreatic Cancer

Purpose

Phase II study of modified FOLFIRINOX in advanced pancreatic cancer.

Investigator

Neal A Fischbach, MD

Contact Information

For more information about this study and to inquire about eligibility, (203) 384-3611.

Eligibility

The eligibility criteria for this study are as follows.

Disease Characteristics:

  • Pathologic or cytologic documentation of pancreatic adenocarcinoma
  • Metastatic or locally advanced unresectable disease, including borderline unresectable disease
  • Locally advanced unresectable adenocarcinoma disease as defined as follows:
    • Extrapancreatic involvement, including extensive peripancreatic lymphatic involvement, and/or nodal involvement beyond the peripancreatic tissues;
    • Encasement (more than one-half of the vessel circumference) or occlusion of the superior mesenteric vein (SMV) or the SMV-portal vein confluence; Direct involvement of the superior mesenteric artery (SMA), inferior vena cava, aorta, or celiac axis, as defined by the absence of a fat plane between the low density tumor and these structures on CT scan;

Bilateral SMV or portal vein narrowing will be considered to be locally advanced

  • For patients with locally advanced unresectable disease, borderline disease is further defined as follows:
    • For tumors of the head or body:
      • Severe unilateral bilateral SMV or portal infringement; Less than one-half the circumference (180 degree) tumor abutment on the SMA; Abutment or encasement of the hepatic artery, if reconstructible; Short segment SMV occlusion, if there is an adequate segment of vein above and below the site of tumor involvement to allow for venous resection and reconstruction
    • For tumors of the tail:
      • Less than 180 degree encasement of the SMA or celiac artery
        • Patients with biliary or gastroduodenal obstruction must have drainage or surgical bypass prior to starting chemoradiation
        • Measurable or non-measurable assessable disease

Prior Therapy:

  • No prior treatment (chemotherapy, biological therapy, or radiotherapy) for metastatic or non-metastatic locally advanced unresectable pancreatic cancer
  • 6 months since completion of any prior neoadjuvant or adjuvant therapy (chemotherapy or radiotherapy) for resected pancreatic cancer
  • No prior treatment with oxaliplatin or irinotecan
  • No prior treatment with fluoruouracil or capecitabine unless administered as a radiosensitizing drug during adjuvant/neoadjuvant chemoradiotherapy after/before resection of pancreatic cancer
  • Patients who received chemotherapy > 2 years ago for malignancies other than pancreatic cancer are eligible, provided that chemotherapy was completed > 2 years ago in locally advanced arm
  • There is no evidence of the second malignancy at the time of study entry
  • >4 weeks since major surgery
  • No other concurrent anticancer therapy

Patient Characteristics:

  • ECOG Performance Status: 0-1
  • Age > 18
  • No other malignancy within past two years except basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer
  • Paraffin block or slides must be available
  • Adequate organ function
  • No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
  • No > grade 2 sensory peripheral neuropathy
  • No uncontrolled seizure disorder, active neurological disease, or known CNS disease
  • No significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment
  • No history of chronic diarrhea
  • Not pregnant and not nursing
  • No other medical condition or reason that, in the opinion of the investigator, would preclude study participation
  • Laboratory parameters as follows: absolute neutrophil count ³1,500/uL, platelet count ³100,000/uL, hemoglobin ³9 g,/dL, creatinine <1.5 X ULN or estimated GFR >30 ml/min, bilirubin <1.5 X ULN, AST and ALT <3 X ULN, negative pregnancy test in women of childbearing age