Pancreatic Cancer
Conditions
Keywords
cancer, pancreatic cancer, gemcitabine, sunitinib, Phase 2
Brief summary
Primary objective: to evaluate whether the addition of sunitinib prolongates the Progression-Free Survival (PFS) in patients with advanced pancreatic cancer receiving first-line gemcitabine chemotherapy.
Interventions
DRUGGemcitabine + Sunitinib
Gemcitabine 1.000 mg/m2, d1,8q3weeks Sunitinib 50 mg/day (2weeks on/1weeks off)
DRUGGemcitabine
1.000 mg/m2 d1,8,15q4weeks
Sponsors
Central European Society for Anticancer Drug Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 (RECIST). * 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 liver metastases. * Serum creatinine \< 1.5 x upper limit of normal * Normal ECG without QT prolongation
Exclusion criteria
* 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 chronic diarrhea * 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Progression | once all patients completed treatment |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate (RR) | once all patients completed treatment |
| overall survival | at study end |
| Safety | at study end |
Countries
Germany, Switzerland
Outcome results
None listed