First-Line Gemcitabine Chemotherapy With Our Without Sunitinib In Advanced or Metastatic Pancreatic Cancer

Central European Society for Anticancer Drug Research

Status and phase

Completed

Phase 2

Conditions

Pancreatic Cancer

Treatments

Drug: Gemcitabine + Sunitinib

Drug: Gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT00673504

C-II-004 / 2007-005022-71

Details and patient eligibility

About

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.

Enrollment

105 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)