Sunitinib Malate in Treating Patients With Small Cell Lung 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 enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sunitinib malate works in treating patients with small cell lung cancer.

Detailed Description
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OBJECTIVES: Primary To assess the therapeutic activity of sunitinib malate in patients with either chemonaïve extensive stage or sensitive relapsed small cell lung cancer. Secondary To characterize the safety of sunitinib malate in these patients. Tertiary To determine the potential of FDG-PET-scan to serve as a surrogate marker of response for the antiangiogenic activity of the compound. OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (chemonaïve extensive stage vs sensitive relapse at least 3 months after stopping chemotherapy). Patients receive oral sunitinib malate once daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo fludeoxyglucose F 18 positron emission tomography of the chest at week 4. Blood samples and bronchial washings and brushings may be collected at baseline and at 4 and 8 weeks after start of therapy for further analysis. After completion of study treatment, patients are followed up every 3 months.

Official Title
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Phase II Study of Sunitinib (SU011248) in Patients With Small Cell Lung Cancer Who Are Either Chemo-naïve (Extensive Disease) or Have a Sensitive Relapse

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: sunitinib malate
* Other: laboratory biomarker analysis
* Radiation: fludeoxyglucose F 18


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed small cell lung cancer Chemotherapy naïve (extensive stage) OR sensitive relapse (> 3 months since induction therapy) disease Measurable disease, as defined by RECIST criteria No brain metastases as assessed by CT scan or MRI performed < 1 week before treatment PATIENT CHARACTERISTICS: WHO performance status 0-2 Life expectancy > 12 weeks Absolute neutrophil count ≥ 1.5 x 10^9/L Platelet count ≥ 100 x 10^9/L AST and ALT ≤ 2.5 x upper limit of normal (ULN) (≤ 5 x ULN if liver function abnormalities are due to underlying malignancy) Total serum bilirubin ≤ 1.5 x ULN Serum albumin ≥ 3.0 g/dL Negative pregnancy test Not pregnant or nursing Fertile patients must use effective contraception during and for 3 months after study treatment No spinal cord compression, carcinomatous meningitis, or leptomeningeal disease No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus within the past 6 months No NCI CTCAE grade 3 hemorrhage within the past 4 weeks No hypertension (> 150/100 mm Hg) that cannot be controlled with standard antihypertensive agents No ongoing cardiac dysrhythmias of grade ≥ 2, atrial fibrillation of any grade, or QTc interval > 450 msec for males or > 470 msec for females No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study drug administration or may interfere with the interpretation of study results, and, in the judgment of the investigator, would make the patient inappropriate for entry into this study No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule PRIOR CONCURRENT THERAPY: More than 4 weeks since prior chemotherapy, surgery, or investigational agents At least 1 month since prior radiotherapy except for palliative radiotherapy to non-target lesions No prior treatment with sunitinib malate (SU011248) or other receptor tyrosine kinase inhibitors No concurrent treatment with steroids No concurrent treatment with a drug having proarrhythmic potential (i.e., terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide) More than 7 and 12 days and no concurrent potent CYP3A4 inhibitors and inducers, respectively Concurrent coumarin-derivative anticoagulants, such as warfarin (Coumadin®) up to 2 mg daily are permitted for prophylaxis of thrombosis No other concurrent anticancer treatments, including chemotherapy, immunotherapy, targeted agents, hormonal cancer therapy, radiation therapy, or experimental treatments

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sunitinib malate|nan|
|Other: laboratory biomarker analysis|nan|
|Radiation: fludeoxyglucose F 18|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate (percentage of patients with complete response, partial response, or stable disease) 8 weeks after beginning treatment according to RECIST criteria |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate every 4 weeks according to RECIST criteria |  |  | 
| Duration of progression-free survival |  |  | 
| Duration of response |  |  | 
| Duration of survival |  |  | 
| Toxicity according to NCI CTCAE version 3.0 |  |  | 
| Accuracy of FDG-PET scan as a potential early surrogate marker of antiangiogenic activity for response |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extensive stage small cell lung cancer, recurrent small cell lung cancer