Second Line Chemotherapy for Advanced Pancreatic Cancer

Folfiri as Second-Line Chemotherapy for Advanced Pancreatic Cancer. A GISCAD Phase II Study

No validated second-line chemotherapy for the treatment of locally advanced/metastatic pancreatic cancer is actually available,after the failure of a gemcitabine(+/- Cisplatin or Oxaliplatin)-based regimen.

Irinotecan seems to be a moderately active drug in the treatment of this disease Recently was reported some interesting results using a potentially non -cross resistant regimen (FOLFIRI) which could be useful even as second-line chemotherapy.

An exploratory study in this setting seem warranted.

Inclusion Criteria:

• Signed written informed consent prior to beginning protocol specific procedures
• Previous chemotherapy with Gemcitabine plus or less Platinoids
• Previous gemcitabine delivered as a radiosensitizer for locally advanced disease, followed or not by a gemcitabine plus or less platinoids as maintenance or disease progression is allowed.
• Male or female less than 75 years of age
• Diagnosis of histologically or cytologically confirmed adenocarcinoma of the pancreas
• Locally advanced (non-resectable) or metastatic pancreatic cancer
• Presence of at least one uni-dimensional indicator lesion measurable by CT scan or MRI in not an irradiated area
• ECOG performance status 0 to 1 at study entry
• Life expectancy: more than 3 months
• Neutrophils more than 1.5 x 109L, platelets more than 100 x 109L, and hemoglobin more than 10 gdL
• Bilirubin level either normal or less than 1.5 x ULN
• ASAT and ALAT normal or less than 2.5 x ULN (normal or less than 5 x ULN if liver metastasis are present)
• Serum creatinine less than 1.5 x ULN
• Amylase normal or less than 1.5 ULN
• Effective contraception for both male and female patients if the risk of conception exists
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial

Exclusion Criteria:

• Brain metastases
• Previous treatment with irinotecan or fluoropyrimidines
• Significant cardiovascular disease: clinically relevant coronary artery disease or a history of a myocardial infarction within the last 6 months
• Significant gastrointestinal abnormalities
• Gilbert's Syndrome
• Any uncontrolled infections
• Known HIV infection
• Radiotherapy within 4 weeks prior to study entry
• Any investigational agents 4 weeks prior to entry
• Known grade 3 or 4 allergic reaction to any of the components of the treatment
• Known drug abuse or alcohol abuse
• Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
• Women who are pregnant or breastfeeding
• Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix.
• Legal incapacity or limited legal capacity