Condition / Intervention Pancreatic Cancer
Title Yale Pancreatic Study
Study # IRB111201
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
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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