Status:
COMPLETED
First-Line Gemcitabine Chemotherapy With Our Without Sunitinib In Advanced or Metastatic Pancreatic Cancer
Lead Sponsor:
Central European Society for Anticancer Drug Research
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 chemothera...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00673504
Start Date
April 1 2008
End Date
November 1 2011
Last Update
December 1 2011
Active Locations (11)
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1
Städtisches Klinikum Braunschweig
Braunschweig, Germany, 38114
2
Universitätsklinikum Essen
Essen, Germany, 45122
3
Krankenhaus
Frankfurt, Germany, 60488
4
Klinikum der J. W. Goethe Universität; Zentrum der Inneren Medizin
Frankfurt, Germany, 60590