Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer

Study Overview
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Brief Summary
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RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the tyrosine kinases needed for angiogenesis and cell growth. It is not yet known whether sunitinib malate is effective as maintenance therapy in delaying tumor progression in patients with metastatic pancreatic cancer who are progression-free after 6 months of induction chemotherapy. PURPOSE: This randomized phase II trial is studying sunitinib malate as maintenance therapy to see how well it works compared with observation in avoiding tumor progression after induction chemotherapy in patients with metastatic pancreatic cancer.

Detailed Description
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OBJECTIVES: Compare the 6-month progression-free survival of patients with metastatic pancreatic cancer without progression after 6 months of induction chemotherapy treated with sunitinib malate as maintenance therapy vs observation. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive oral sunitinib malate once daily for up to 6 months in the absence of disease progression or unacceptable toxicity. Arm II: Patients undergo observation only.

Official Title
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Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer: a Phase II Randomized Trial.

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: sunitinib


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Pathologically confirmed metastatic pancreatic adenocarcinoma Stage IV disease Received chemotherapy for a duration of 6 months No progressive disease for ≥ 6 months since beginning of induction chemotherapy (irrespective of regimen and response: stable disease, partial response, or complete response) demonstrated by the following: Two consecutive CT or MR scans separated by ≥ 6 weeks Normal or no CA19.9 increase > 20% during the last month PATIENT CHARACTERISTICS: Karnofsky Performance Status 50-100% Adequate bone marrow, liver, and kidney function Normal thyroid gland function (euthyroid) Not pregnant or nursing No duodenal, gastric, or intestinal infiltration Able to take oral medication None of the following conditions related to cardiac disease, failure, or vascular disease including any of the following: QTc interval prolongation Congestive heart failure Serious cardiac arrhythmias Active coronary artery disease Myocardial infarction Ischemia Cerebrovascular accident Evidence of pre-existing uncontrolled hypertension No other malignancies except surgically cured carcinoma in situ of the cervix, basal or squamous cell carcinoma of the skin, or other adequately treated neoplasms for which the patient has been disease-free for ≥ 5 years PRIOR CONCURRENT THERAPY: See Disease Characteristics No other prior chemotherapy apart from first-line treatment for pancreatic cancer More than 3 weeks and less than 8 weeks since prior chemotherapy (> 1 week in the case of fluorouracil as continuous infusion or capecitabine) No prior antiangiogenesis drugs, including any of the following: Sunitinib malate Sorafenib Bevacizumab AZD2171 Vatalanib VEGF trap Pazopanib More than 1 month since prior major surgical procedure and completely recovered More than 7-12 days since prior and no concurrent drugs that are known CYP3A4 inhibitors No concurrent drugs with potential anti-arrhythmic activity No concurrent thrombolytic agent at therapeutical dose No concurrent treatment with other experimental drugs

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 |
| --- | --- |
| No Intervention: observation<br>no therapy until progression | |
| Experimental: sunitinib<br>sunitinib until progression or for a maximum of 6 months | Drug: sunitinib<br>* oral sunitinib 37.5 mg daily<br>* Other names: SUTENT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month progression-free survival | CT scan | every 2 months during therapy; every 3 months thereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | CT scan | every 2 months during therapy; every 3 months thereafter | 
| Toxicity | outpatient visit | monthly during therapy | 
| OVERALL SURVIVAL | outpatient visit | monthly | 
| PROGRESSION-FREE SURVIVAL | CT scan | every 2 months during therapy; every 3 months thereafter | 
| endothelial circulating cells |  | baseline + every 2 months during therapy until progression | 
| pharmacogenomics |  | baseline | 
| pharmacokynetics |  | after 2 months of therapy | 
| pharmacodynamics |  | baseline and every 2 months until progression | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the pancreas, stage IV pancreatic cancer