Trial of Infusional FOLFIRINOX in First Line Treatment of Advanced Biliary Tract Cancers

Inclusion Criteria:

1. Histologically confirmed locally advanced (irresectable) or metastatic biliary tract cancers.
2. Measurable disease. Defined as tumor that have uni or bi dimensional measurement not less than 1.5 cm on any dimension.
3. Age ≥ 18 years.
4. Signed written informed consent before enrolment.
5. No prior chemotherapy or anti-neoplastic therapy other than radiotherapy more than 4 weeks prior to enrolment and to areas other than the measurable disease.
6. Patients of either sex or child bearing age must be willing to use adequate contraceptive measures during the study and for 6 months after treatment.
7. Life expectancy of 6 months or more.
8. Eastern Cooperative Oncology Group performance status of 0-1.
9. Adequate renal function: creatinine within normal institutional range.
10. Adequate hepatic function: Total bilirubin within normal institutional limits, serum aspartate aminotransferase and alanine aminotransferase levels ≤2.5 times the institutional upper limit of normal or ≤ 5 times the institutional upper limit of normal of elevated because of liver involvement.
11. Adequate hematological values: leukocyte count ≥3.0 x 109/L, an absolute neutrophil count ≥1.5 x 109/L, a platelet count ≥100 x 109/L.

Exclusion Criteria:

1. Known or suspected dihydropyrimidine deficiency.
2. Presence of central nervous system metastasis.
3. Previous malignancy within 5 years, except adequately treated non melanomatous skin cancer or in situ cervical cancer.
4. Severe cardiovascular disease (congestive heart failure New York Heart Association class three or four, unstable angina pectoris, myocardial infarction or significant arrhythmias).
5. Psychiatric or mental disorder, precluding understanding of the information of the trial related topics and giving valid informed consent.
6. Active uncontrolled infection.
7. Pregnant patients (confirmed by β-Human chorionic gonadotrophin test where appropriate).
8. Serious underlying medical condition (in the judgement of the investigator) which could impair the ability of the patient to participate in the trial.
9. Any psychological, familial, geographic or social circumstances which could impair the patient's ability to participate in the trial and comply with follow up.
10. Treatment with other experimental drugs within 30 days of entry into the trial.
11. Treatment with other anti-cancer therapy.
12. Known hypersensitivity to any of the study drugs.
13. Breast feeding
14. Legal incapacity.
15. Patients with a known diagnosis of HIV infection.