First-Line Gemcitabine Chemotherapy With Our Without Sunitinib In Advanced or Metastatic Pancreatic Cancer
Phase 2
Completed
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00673504
- Lead Sponsor
- Central European Society for Anticancer Drug Research
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
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
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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)
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Gemcitabine + Sunitinib Gemcitabine + Sunitinib B Gemcitabine Gemcitabine
- Primary Outcome Measures
Name Time Method Time to Progression once all patients completed treatment
- Secondary Outcome Measures
Name Time Method Response Rate (RR) once all patients completed treatment overall survival at study end Safety at study end
Trial Locations
- Locations (11)
Klinikum Lüdenscheid
🇩🇪Luedenscheid, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
Martin-Luther-Universität Halle-Wittenberg; Medizinische Fakultät
🇩🇪Halle (Saale), Germany
Robert-Bosch-Krankenhaus
🇩🇪Stuttgart, Germany
Städtisches Klinikum Braunschweig
🇩🇪Braunschweig, Germany
Klinikum Nürnberg Nord
🇩🇪Nürnberg, Germany
Krankenhaus
🇩🇪Frankfurt, Germany
Klinikum der J. W. Goethe Universität; Zentrum der Inneren Medizin
🇩🇪Frankfurt, Germany
Internistisches Facharztzentrum
🇩🇪Frankfurt, Germany
Facharztpraxis
🇩🇪Heidelberg, Germany
Kantonsspital St. Gallen
🇨🇭St. Gallen, Switzerland