Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-26 @ 5:46 PM
Study NCT ID:
NCT00953459
Status:
TERMINATED
Last Update Posted:
2018-07-26
First Post:
2009-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sunitinib Malate in Treating Patients With Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077210', 'term': 'Sunitinib'}, {'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'poorly recruiting', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-25', 'studyFirstSubmitDate': '2009-08-05', 'studyFirstSubmitQcDate': '2009-08-05', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease control rate (percentage of patients with complete response, partial response, or stable disease) 8 weeks after beginning treatment according to RECIST criteria'}], 'secondaryOutcomes': [{'measure': 'Response rate every 4 weeks according to RECIST criteria'}, {'measure': 'Duration of progression-free survival'}, {'measure': 'Duration of response'}, {'measure': 'Duration of survival'}, {'measure': 'Toxicity according to NCI CTCAE version 3.0'}, {'measure': 'Accuracy of FDG-PET scan as a potential early surrogate marker of antiangiogenic activity for response'}]}, 'conditionsModule': {'keywords': ['extensive stage small cell lung cancer', 'recurrent small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: This phase II trial is studying how well sunitinib malate works in treating patients with small cell lung cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To assess the therapeutic activity of sunitinib malate in patients with either chemonaïve extensive stage or sensitive relapsed small cell lung cancer.\n\nSecondary\n\n* To characterize the safety of sunitinib malate in these patients.\n\nTertiary\n\n* To determine the potential of FDG-PET-scan to serve as a surrogate marker of response for the antiangiogenic activity of the compound.\n\nOUTLINE: 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).\n\nPatients receive oral sunitinib malate once daily for up to 1 year in the absence of disease progression or unacceptable toxicity.\n\nPatients 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.\n\nAfter completion of study treatment, patients are followed up every 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed small cell lung cancer\n\n * Chemotherapy naïve (extensive stage) OR sensitive relapse (\\> 3 months since induction therapy) disease\n* Measurable disease, as defined by RECIST criteria\n* No brain metastases as assessed by CT scan or MRI performed \\< 1 week before treatment\n\nPATIENT CHARACTERISTICS:\n\n* WHO performance status 0-2\n* Life expectancy \\> 12 weeks\n* Absolute neutrophil count ≥ 1.5 x 10\\^9/L\n* Platelet count ≥ 100 x 10\\^9/L\n* AST and ALT ≤ 2.5 x upper limit of normal (ULN) (≤ 5 x ULN if liver function abnormalities are due to underlying malignancy)\n* Total serum bilirubin ≤ 1.5 x ULN\n* Serum albumin ≥ 3.0 g/dL\n* Negative pregnancy test\n* Not pregnant or nursing\n* Fertile patients must use effective contraception during and for 3 months after study treatment\n* No spinal cord compression, carcinomatous meningitis, or leptomeningeal disease\n* 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\n* No NCI CTCAE grade 3 hemorrhage within the past 4 weeks\n* No hypertension (\\> 150/100 mm Hg) that cannot be controlled with standard antihypertensive agents\n* No ongoing cardiac dysrhythmias of grade ≥ 2, atrial fibrillation of any grade, or QTc interval \\> 450 msec for males or \\> 470 msec for females\n* 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\n* No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n\nPRIOR CONCURRENT THERAPY:\n\n* More than 4 weeks since prior chemotherapy, surgery, or investigational agents\n* At least 1 month since prior radiotherapy except for palliative radiotherapy to non-target lesions\n* No prior treatment with sunitinib malate (SU011248) or other receptor tyrosine kinase inhibitors\n* No concurrent treatment with steroids\n* No concurrent treatment with a drug having proarrhythmic potential (i.e., terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide)\n* More than 7 and 12 days and no concurrent potent CYP3A4 inhibitors and inducers, respectively\n* Concurrent coumarin-derivative anticoagulants, such as warfarin (Coumadin®) up to 2 mg daily are permitted for prophylaxis of thrombosis\n* No other concurrent anticancer treatments, including chemotherapy, immunotherapy, targeted agents, hormonal cancer therapy, radiation therapy, or experimental treatments'}, 'identificationModule': {'nctId': 'NCT00953459', 'briefTitle': 'Sunitinib Malate in Treating Patients With Small Cell Lung Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'EORTC-08061'}, 'secondaryIdInfos': [{'id': 'EU-20910'}, {'id': '2006-002485-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'sunitinib malate', 'type': 'DRUG'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'fludeoxyglucose F 18', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1007 MB', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Vrije Universiteit Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Egbert F. Smit, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Free University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}