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