Prospective Randomized Phase II Trial With Gemcitabine Plus Sunitinib Versus Gemcitabine Alone in First-line Therapy of Metastatic or Locally Advanced Pancreatic Cancer

Central European Society for Anticancer Drug Research11 sites in 2 countries105 target enrollmentApril 2008

ConditionsPancreatic Cancer

InterventionsGemcitabine + Sunitinib Gemcitabine

DrugsGemcitabine + Sunitinib Gemcitabine

Overview

Phase: Phase 2
Intervention: Gemcitabine + Sunitinib
Conditions: Pancreatic Cancer
Sponsor: Central European Society for Anticancer Drug Research
Enrollment: 105
Locations: 11
Primary Endpoint: Time to Progression
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

November 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Central European Society for Anticancer Drug Research

Eligibility Criteria

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