Prospective Randomized Phase II Trial With Gemcitabine Plus Sunitinib Versus Gemcitabine Alone in First-line Therapy of Metastatic or Locally Advanced Pancreatic Cancer
- Patients who suffer from locally advanced or metastatic pancreatic cancer
- Patients with measurable disease (at least one uni-dimensionally measurable target
lesion by CT-scan or MRI) according to Response Evaluation Criteria in Solid Tumors
- ECOG performance status 0 to 1
- Signed written informed consent.
- White blood cell count (WBC) >= 3x10^9/L with neutrophils >= 1.5 x 10^9/L, platelet
count >= 100x10^9/L, hemoglobin >= 5.6 mmol/L (9 g/dL).
- Total bilirubin < 2 x upper limit of normal.
- AST and ALT < 2.5 x upper limit of normal, or < 5 x upper limit of normal in case of
- Serum creatinine < 1.5 x upper limit of normal
- Normal ECG without QT prolongation
- Resectable pancreatic cancer
- Previous chemotherapy (for adjuvant or metastatic disease)
- Any investigational drug within the 30 days before inclusion.
- Prior use of sunitinib or other multitarget tyrosine kinase inhibitor
- Pregnancy (absence to be confirmed by beta-hCG test) or lactation period.
- Men or women of child-bearing potential who are sexually active and unwilling to use
a medically acceptable method of contraception during the trial.
- Clinically symptomatic brain or meningeal metastasis. (known or suspected)
- Cardiac arrhythmias requiring anti-arrhythmics (excluding beta blockers or digoxin).
- History of any of the following cardiac events within the past 6 months: myocardial
infarction (including severe/unstable angina; coronary/peripheral artery bypass
graft; symptomatic congestive heart failure (CHF) > NYHA Class II; cerebrovascular
accident or transient ischemic attack; pulmonary embolism
- Uncontrolled severe hypertension (failure of diastolic blood pressure to fall below
90 mm Hg despite the use of up to 3 anti-hypertensive drugs
- Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease or
- Previous malignancy (other than pancreatic cancer) in the last 5 years except basal
cell cancer of the skin, pre-invasive cancer of the cervix or superficial bladder
tumor [Ta, Tis and T1].
- History of organ allograft
- Patients requiring long-term cortisone therapy
- Patients requiring oral anticoagulation treatment (such as marcoumar)