Metastatic Advanced Pancreas Sorafenib (MAPS)

This is an interventional treatment trial for Locally Advanced Pancreatic Cancer focused on measuring pancreatic cancer, advanced or metastatic, sorafenib Read More

Inclusion Criteria:

• Signed written informed consent prior to beginning protocol specific procedures
• Male or female 18 to 75 years of age
• Diagnosis of histologically 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 (RECIST criteria)
• Karnofsky performance status of ≥ 70 at study entry
• Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL
• Bilirubin level either normal or < 1.5 x ULN
• ASAT and ALAT ≤ 2.5 X ULN (≤ 5 x ULN if liver metastasis are present)
• Serum creatinine < 1.5 x ULN
• Amylase and lipase ≤ 1.5 x the upper limit of normal
• PT or INR and PTT < 1.5 x upper limit of normal (subjects who receive anti-coagulation treatment with an agent such as warfarin or heparin will be allowed to participate provided that no evidence of underlying abnormality in these parameters exists).
• Effective contraception for both male and female patients if the risk of conception exists

Exclusion Criteria:

• Brain metastases
• Previous chemotherapy for locally advanced or metastatic pancreatic cancer.
• Adjuvant therapy if documented recurrence is within 6 months after the end of adjuvant treatment)
• Radiotherapy within 4 weeks prior to study entry
• Major surgery within 4 weeks of first dose of study drug
• Concurrent chronic systemic immune therapy
• Any investigational agent(s) 4 weeks prior to entry
• Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 6 months
• Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
• Acute or subacute intestinal occlusion or history of inflammatory bowel disease
• Known grade 3 or 4 allergic reaction to any of the components of the treatment
• Known drug abuse/ alcohol abuse
• Legal incapacity or limited legal capacity
• 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
• Acute or subacute intestinal occlusion
• Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial).