Intervention: Folfirinox Regimen
Trial phase: Phase 2
SMILES: CCc1c2c(nc3ccc(OC(=O)N4CCC(N5CCCCC5)CC4)cc13)-c1cc3c(c(=O)n1C2)COC(=O)C3(O)CC.Nc1nc2c(c(=O)[nH]1)N(C=O)C(CNc1ccc(C(=O)NC(CCC(=O)O)C(=O)O)cc1)CN2.O=C([O-])C(=O)[O-].O=c1[nH]cc(F)c(=O)[nH]1.[NH-]C1CCCCC1[NH-].[Pt+4]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
Eligibility criteria:
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