Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Written informed consent, signed and dated
Locally advanced, inoperable and stage IV pancreatic cancer patients according to UICC based on diagnostic imaging using computer-tomography (CT) or histological examinations
Male or post-menopausal female
Age above or equal to 18 years
Chemotherapy naïve within 60 days before screening visit except gemcitabine treatment
Karnovsky index >70
Life expectancy >3 months
Adequate renal, hepatic, and bone marrow function
Absolute neutrophil count >1500/µL
Hemoglobin >10 g/dL
Platelets >75000/µL
Prothrombin time and international normalized ratio (INR) <1.5 times upper limit of normal (ULN) (except under anticoagulant treatment)
Aspartate aminotransferase <4 times ULN
Alanine aminotransferase <4 times ULN
Total bilirubin <3 times ULN
Creatinine clearance estimated according to Cockcroft-Gault >30 mL/min
Proteinuria <1 g protein on 24 h urine collection

Exclusion Criteria:

State after pancreas resection (complete or partial)
Resectable disease
Drug trial participation within 60 days before screening visit
Other previous or current malignancy except basal or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for <2 years
Prior vaccination with Ty21a

Cardiovascular disease defined as:

Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg)
Arterial thromboembolic event within 6 months before randomization including:
Myocardial infarction
Unstable angina pectoris
Cerebrovascular accident
Transient ischemic attack
Congestive heart failure New York Heart Association grade III to IV
Serious ventricular arrhythmia requiring medication
Clinically significant peripheral artery disease > grade 2b according to Fontaine
Hemoptysis within 6 months before randomization
Esophageal varices
Upper or lower gastrointestinal bleeding within 6 months before randomization
Significant traumatic injury within 4 weeks before randomization
Non-healing wound, bone fracture or any history of gastrointestinal ulcers within three years before inclusion, or positive gastroscopy within 3 months before inclusion
Gastrointestinal fistula
Thrombolysis therapy within 4 weeks before randomization
Bowel obstruction within the last 30 days before screening visit
Liver cirrhosis ≥ grade B according to Child-Pugh Score-Classification
Presence of any acute or chronic systemic infection
Radiotherapy within 4 weeks before randomization
Major surgical procedures, or open biopsy within 4 weeks before randomization
Fine needle aspiration within 7 days before randomization

Chronic concurrent therapy within 2 weeks before and during the double-blind study period with:

Corticosteroids (except steroids for adrenal failure) or immunosuppressive agents
Antibiotics
Bevacizumab
Any epidermal growth factor receptor inhibitor
Chemotherapy except gemcitabine before Day 10
Multi-drug resistant gram-negative germ
Pregnancy
Lactation
Inability to comply with study and/or follow-up procedures
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the study results or render the patient at high risk for treatment complications
Women of childbearing potential
Any history of drug hypersensitivity
Any condition which results in an undue risk for the patient during the study participation according to the investigator