Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT00066612
Status:
COMPLETED
Last Update Posted:
2012-11-02
First Post:
2003-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
S0306, Irinotecan in Treating Patients With Recurrent or Refractory Advanced Transitional Cell Cancer of the Urothelium Previously Treated With Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D014523', 'term': 'Urethral 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'}, {'id': 'D014522', 'term': 'Urethral Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077146', 'term': 'Irinotecan'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-31', 'studyFirstSubmitDate': '2003-08-06', 'studyFirstSubmitQcDate': '2003-08-06', 'lastUpdatePostDateStruct': {'date': '2012-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Probability of response (confirmed complete and partial response)', 'timeFrame': 'From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years'}], 'secondaryOutcomes': [{'measure': 'Number and grade of adverse events', 'timeFrame': 'From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years'}, {'measure': 'Overall survival', 'timeFrame': 'From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years'}, {'measure': 'Progression-free survival', 'timeFrame': 'From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent bladder cancer', 'stage IV bladder cancer', 'metastatic transitional cell cancer of the renal pelvis and ureter', 'recurrent transitional cell cancer of the renal pelvis and ureter', 'regional transitional cell cancer of the renal pelvis and ureter', 'transitional cell carcinoma of the bladder', 'anterior urethral cancer', 'posterior urethral cancer', 'recurrent urethral cancer', 'urethral cancer associated with invasive bladder cancer'], 'conditions': ['Bladder Cancer', 'Transitional Cell Cancer of the Renal Pelvis and Ureter', 'Urethral Cancer']}, 'referencesModule': {'references': [{'pmid': '18501081', 'type': 'RESULT', 'citation': 'Beer TM, Goldman B, Nichols CR, Petrylak DP, Agarwal M, Ryan CW, Crawford ED; Southwest Oncology Group. Southwest Oncology Group phase II study of irinotecan in patients with advanced transitional cell carcinoma of the urothelium that progressed after platinum-based chemotherapy. Clin Genitourin Cancer. 2008 Mar;6(1):36-9. doi: 10.3816/cgc.2008.n.006.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have recurrent or refractory advanced transitional cell cancer of the urothelium.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the probability of response (confirmed complete and partial response) to treatment with irinotecan in patients with recurrent or refractory advanced transitional cell carcinoma of the urothelium previously treated with platinum-based chemotherapy.\n* Determine the qualitative and quantitative toxic effects of this drug in these patients.\n* Determine the overall and progression-free survival of patients treated with this drug.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to prior pelvic radiotherapy (yes vs no).\n\nPatients receive irinotecan IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months for 1 year and then every 6 months for 2 years.\n\nPROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-10 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed transitional cell carcinoma (TCC) of the urothelium, including the bladder, renal pelvis, ureter, and urethra\n\n * Stage T2-4, N0-3, M1 OR stage T2-4, N+, M0, unresectable disease\n * The following additional histologic subtypes are eligible:\n\n * Poorly differentiated TCC\n * Predominant TCC with rare foci of squamous differentiation\n * Predominant TCC with rare foci of adenocarcinoma\n * The following histologic subtypes are ineligible:\n\n * Adenocarcinoma\n * Small cell carcinoma\n * Sarcoma\n * Squamous cell carcinoma\n * Mixed adeno/squamous/transitional histology\n* Incurable by surgery or radiotherapy\n* Progressed or recurred after 1, and only 1, prior cisplatin- or carboplatin-containing systemic regimen for metastatic disease\n* Measurable disease\n\n * Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease\n* No uncontrolled central nervous system (CNS) metastases\n\n * CNS metastases that have responded to or stabilized after prior radiotherapy are allowed\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Zubrod 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Absolute granulocyte count at least 1,200/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin less than 1.5 times upper limit of normal (ULN)\n* Aspartate aminotransferase (SGOT) less than 3 times ULN (5 times ULN if liver metastases are present)\n\nRenal\n\n* Creatinine less than 2 times ULN\n\nOther\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in complete remission\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* See Disease Characteristics\n* At least 28 days since prior chemotherapy\n* No prior topoisomerase I inhibitors (e.g., irinotecan or topotecan)\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* See Disease Characteristics\n* At least 28 days since prior radiotherapy to the pelvis\n\nSurgery\n\n* Not specified\n\nOther\n\n* Recovered from prior therapy\n* Prior adjuvant therapy allowed\n* At least 14 days since prior Hypericum perforatum (St. John's Wort)\n* More than 7 days since prior phenytoin, phenobarbital, carbamazepine, or any other enzyme-inducing anticonvulsant drugs (EIACDs)\n* No St. John's Wort during and for 7 days after study participation\n* No concurrent EIACDs\n* No concurrent medications that cause myelosuppression\n* No concurrent medications that cause diarrhea\n* Concurrent gabapentin or other non-EIACDs are allowed"}, 'identificationModule': {'nctId': 'NCT00066612', 'briefTitle': 'S0306, Irinotecan in Treating Patients With Recurrent or Refractory Advanced Transitional Cell Cancer of the Urothelium Previously Treated With Chemotherapy', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'Phase II Study of Irinotecan in Patients With Advanced Transitional Cell Carcinoma of the Urothelium', 'orgStudyIdInfo': {'id': 'CDR0000316428'}, 'secondaryIdInfos': [{'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}, {'id': 'S0306', 'type': 'OTHER', 'domain': 'SWOG'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Irinotecan', 'interventionNames': ['Drug: irinotecan hydrochloride']}], 'interventions': [{'name': 'irinotecan hydrochloride', 'type': 'DRUG', 'description': 'Irinotecan will be given 250 mg/m\\^2 through intravenous (IV) for 90 minutes on day 1 for every 21 days until tumor progression or unacceptable toxicity or other reason for discontinuation occurs', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Tomasz M. Beer, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'OHSU Knight Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SWOG Cancer Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}