Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ERYtech Pharma
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Exocrine pancreatic adenocarcinoma cytologically or histologically confirmed
Locally advanced and non-resectable with invasion of the superior mesenteric artery (stage III) or metastatic (stage IV) as defined by TNM (primary tumor, regional nodes, metastasis) 2002 classification (UICC 2002)
resistant to a first or second line chemotherapy with gemcitabine
Patient aged between 18 to 70 years
Signed Informed Consent Form
Life expectancy ≥ 12 weeks
Accurate measurement of tumor volume by imagery (in at least one dimension)
Presence of one or several tumor markers (carcinoembryonic antigen \[CEA\] and cancer antigen \[CA\] 19.9)
Eastern Cooperative Oncology Group \[ECOG\] Prognostic Score : 0, 1 or 2
Patient beneficiary of a Social Security Insurance
You may not be if
Patient with an endocrine or acinar pancreatic tumor
Patient with known or suspected cerebro-meningeal metastases
Haemoglobin level greater than 13 g/L
Patient hypersensitive to L-asparaginase or have had prior exposure to any form of L-asparaginase
Splenic vein thrombosis \< 3 months or under active treatment
Anti-vitamin K treatment
Hepatic Insufficiency unrelated to pancreatic cancer
Renal insufficiency unrelated to pancreatic cancer
Pancreatitis or pancreatitis history unrelated to pancreatic cancer
Insulin-dependant diabetes mellitus unrelated to pancreatic cancer
Current or prior coagulopathy disorders unrelated to pancreatic cancer
ECOG Prognostic Score 3 or 4
History of grade 3 blood transfusion reaction (life threatening situation)
Presence of rare and dangerous anti-erythrocyte antibodies preventing from getting a compatible packed Red Blood Cells for the patient
Patient already included in another clinical trial
Pregnancy, breast-feeding or absence of secured contraception
