Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-01-01 @ 10:54 PM
Study NCT ID:
NCT00818350
Status:
UNKNOWN
Last Update Posted:
2009-01-07
First Post:
2009-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Activity Study of Sunitinib In Metastatic Pretreated Urothelial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077210', 'term': 'Sunitinib'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-01-06', 'studyFirstSubmitDate': '2009-01-05', 'studyFirstSubmitQcDate': '2009-01-06', 'lastUpdatePostDateStruct': {'date': '2009-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the antitumor efficacy ( response rate) of sunitinib', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'QOL', 'timeFrame': '6 WEEKS'}, {'measure': 'TOXICITY ACCORDING NCI VERSION 3 CRITERIA', 'timeFrame': 'EVERY WEEK'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Urinary Bladder Neoplasms']}, 'descriptionModule': {'briefSummary': 'Gemcitabine and cisplatin represent the standard first-line chemotherapy in metastatic bladder carcinoma. This regimen has replaced in most centers the MVAC combination showing a similar efficacy but less toxicity.\n\nAlmost all responding patients relapse within the first year, with a median survival of 12 months. Prognosis is very poor in patients who display progressive disease after receiving combination cisplatin-based chemotherapy.\n\nNo standard has yet been established for second-line treatment and well designed trials of second-line chemotherapy for metastatic transitional carcinoma of the urothelium should be given high priority.\n\nSeveral drugs have been used in second line for metastatic disease with poor results.\n\nThe investigators have planned a Phase II study, open-label, single arm design to evaluate the activity and safety of sunitinib in metastatic urothelial carcinoma, pretreated with standard regimen (cisplatin-gemcitabine).\n\nNo previous studies have been published with sunitinib in metastatic bladder cancer.', 'detailedDescription': 'OBJECTIVES\n\n* PRIMARY To determine the antitumor efficacy ( response rate) of sunitinib\n* SECONDARY To determine: safety, duration of response, Quality of life (QoL), progression free survival (PFS) and overall survival (OS).\n\nPLAN OF TREATMENT Patients received sunitinib at a starting dose of 50 mg per day in repeated 6-week cycles for 4 consecutive weeks followed by 2 weeks off treatment.\n\nSunitinib was self-administered orally once daily without regard to meals. Dose reduction for toxicity was allowed to 37.5 until 25 mg/day depending on the type and severity of toxicity encountered.\n\nSunitinib treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent.\n\nEVALUATION\n\nBaseline evaluations included:\n\n* medical history\n* physical examination;\n* tumor assessment (total body TC and bone scan )\n* assessment of ECOG PS\n* QoL assessment\n* Assessment of left ventricular ejection fraction by echocardiography\n* ECG\n* Laboratory measurements. Assessment of efficacy and safety\n* Evaluation according RECIST criteria every 2 cycles (12 weeks) with TC\n* Safety according NCI version 3 every cycle\n* QoL every cycle EORTC-QOL-C30.• RESOURCE UTILIZATION ASSESSMENTS\n\nEORTC QLQ-C30 questionnaire, developed by the EORTC for the measurement of quality of life in cancer patients in clinical trials.\n\nFor the analysis, the raw scores of the questionnaire are transformed into a 100-point scale. For the functional scales, the computed scores range from 0 to 100, with the higher scores representing a higher level of functioning. For the item scales relative to physical symptoms and financial impact, higher scores represent a higher level of symptoms or problems .\n\nSTATISTICAL METHODS\n\nBenefit anticipated (%): \\>30% of response rate. Test size: 5%. Power 80%. Sample size: 25 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cytological confirmation of UROTHELIAL carcinoma\n* Failure of Cisplatin-gemcitabine regimen as first-line\n* Presence of measurable metastases\n* Performance status 0-1 ECOG\n* Age of 18 years or older\n* Written informed consent\n* Adequate organ function ( based on tests of hematologic, hepatic, renal and cardiac function).\n\nExclusion Criteria:\n\n* administration of a previous biological therapy ( sorafenib , bevacizumab or mTor Inhibitor)\n* brain metastases\n* significant cardiac events within the 6 months prior to study drug administration.'}, 'identificationModule': {'nctId': 'NCT00818350', 'briefTitle': 'Activity Study of Sunitinib In Metastatic Pretreated Urothelial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Campania Younger Oncologists Association'}, 'officialTitle': 'Phase II Study of Sunitinib in Metastatic and Pretreated Urothelial Cancer', 'orgStudyIdInfo': {'id': 'AGOC O1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SUNITINIB', 'interventionNames': ['Drug: SUNITINIB']}], 'interventions': [{'name': 'SUNITINIB', 'type': 'DRUG', 'otherNames': ['SUTENT'], 'description': '50 MG ORAL, DAYS 1-28 FOLLOWED BY 2 WEEKS RESTING', 'armGroupLabels': ['SUNITINIB']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'DI LORENZO GIUSEPPE, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Campania Younger Oncologists Association'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Campania Younger Oncologists Association', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'DI LORENZO GIUSEPPE', 'oldOrganization': 'AGOC'}}}}