Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer

Summary: The primary objective of this study is to determine the progression free survival in patients with metastatic pancreatic cancer and in patients with locally advanced unresectable non-metastatic pancreatic cancer treated with a dose-attenuated modification of folinic acid, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX). Secondary endpoints include: determine objective response rate according to RECIST; determine overall survival; evaluate toxicity; determine rate of resection in locally advanced unresectable stratum; correlate time to progression, objective response, and overall survival with early changes in glucose metabolism using [18F]-fluorodeoxyglucose (FDG)-positron emission tomography (PET) scanning.


Eligibility: Inclusion Criteria:
  -  Pathologic or cytologic documentation of pancreatic adenocarcinoma
  -  Metastatic or locally advanced unresectable disease, including borderline unresectable disease
  -  Patients with biliary or gastroduodenal obstruction must have drainage or surgical bypass prior to starting chemoradiation
  -  Measurable or non-measurable assessable disease
  -  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 and there is no evidence of the second malignancy at the time of study entry
  -  > 4 weeks since major surgery
  -  No other concurrent anticancer therapy
  -  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 1 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 ≥ 1,500/uL, platelet count ≥ 100,000/uL, hemoglobin ≥ 9 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

Relevance to patient case: not relevant