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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Gemcitabine + Sunitinib
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Gemcitabine + Sunitinib | Drug: Gemcitabine + Sunitinib<br>* Gemcitabine 1.000 mg/m2, d1,8q3weeks Sunitinib 50 mg/day (2weeks on/1weeks off)<br>|
| Other: B<br>Gemcitabine | Drug: Gemcitabine<br>* 1.000 mg/m2 d1,8,15q4weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression |  | once all patients completed treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate (RR) |  | once all patients completed treatment | 
| overall survival |  | at study end | 
| Safety |  | at study end | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, pancreatic cancer, gemcitabine, sunitinib, Phase 2