Digitoxin Pancreatic cancer trial-1

Prior treatment

• Significant concurrent, uncontrolled medical condition including, but not limited: to renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.

Other illness

• Chronic or current active infectious disease requiring systemic antibiotics, antifungal or antiviral treatment.
• Hypersensitivity to digitoxin or other cardiac glycoside or any other ingredients in the tablets (see SmPC).
• Carotid sinus syndrome.
• Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from day 1 of trial drug administration. Patients with heart disease already on a cardiac glycoside are not eligible.
• Cardiac arrythmia which may worsen by digitoxin therapy.
• Current or previous other malignancy within 2 years of trial entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other non-invasive or indolent malignancy.
• Patient who has already been subjected to or started chemotherapy or other treatment for the pancreatic cancer.

Lab values

• P-ALAT/ASAT > 2.5 × ULN; or > 5 × ULN in the presence of liver metastases.
• Total P-bilirubin > 1.5 × ULN (use of biliary stent to achieve bilirubin levels is permitted).
• S- LDH > 3 × ULN in the absence of haemolysis.
• P-Potassium < 3.5 or > 4.5 mmol/L.
• P-Sodium <137 or >145 mmol/L
• P-Albumin <25 g/L
• P-Calcium < 2.15 or > 2.50 mmol/L.
• S-Magnesium <0.7 mmol/L or > 1.1 mmol/L
• S-creatinine > 150 μmol/L.
• Simultaneous administration of intravenous calcium salts.
• Absolute B-neutrophil count (ANC) <1.5 × 10^9/L.
• B-Platelets < 75 × 10^9/L.
• B-Haemoglobin < 9 g/L (transfusions are permitted to achieve baseline haemoglobin level).

Other

• Pregnancy or female patients that are breastfeeding and not willing to refrain.
• Thoracic aortic aneurysm.
• Intended electrical cardioversion.

• Male or female, 18 years or older.
• Male patients with a female partner of childbearing potential must agree to use an adequate method of contraception (condom and acceptable contraception method for the partner), starting with the first dose of study therapy through 6 months after the last dose of study therapy. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
• WHO performance status 0-2.
• Histologically or cytologically confirmed inoperable adenocarcinoma of the pancreas. Histologically or cytologically confirmed from primary tumor in the pancreas or metastasis.
• The patient shall be newly diagnosed and not have started any other treatment for the pancreatic cancer.
• Radiographically measurable or evaluable disease, according RECIST (v1.1).
• The patient is able to take care of his/her medication.
• The patient has given written consent to participate in the trial.
• Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Female patients of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 6 months after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.