Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-01 @ 2:55 AM
Study NCT ID:
NCT00006351
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2000-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'C115354', 'term': 'lonafarnib'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'lastUpdateSubmitDate': '2012-09-20', 'studyFirstSubmitDate': '2000-10-04', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2012-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-12', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['recurrent bladder cancer', 'stage IV bladder cancer', 'transitional cell carcinoma of the bladder', 'recurrent urethral cancer', 'anterior urethral cancer', 'posterior urethral cancer', 'urethral cancer associated with invasive bladder cancer', 'metastatic transitional cell cancer of the renal pelvis and ureter', 'recurrent transitional cell cancer of the renal pelvis and ureter'], 'conditions': ['Bladder Cancer', 'Transitional Cell Cancer of the Renal Pelvis and Ureter', 'Urethral Cancer']}, 'referencesModule': {'references': [{'pmid': '15911238', 'type': 'RESULT', 'citation': 'Theodore C, Geoffrois L, Vermorken JB, Caponigro F, Fiedler W, Chollet P, Ravaud A, Peters GJ, de Balincourt C, Lacombe D, Fumoleau P. Multicentre EORTC study 16997: feasibility and phase II trial of farnesyl transferase inhibitor & gemcitabine combination in salvage treatment of advanced urothelial tract cancers. Eur J Cancer. 2005 May;41(8):1150-7. doi: 10.1016/j.ejca.2005.02.015.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining SCH 66336 and gemcitabine may kill more tumor cells.\n\nPURPOSE: Phase II trial to study the effectiveness of SCH 66336 plus gemcitabine in treating patients who have advanced cancer of the urinary tract.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the feasibility and toxicity of SCH 66336 and gemcitabine in patients with advanced transitional cell carcinoma of the urinary tract.\n* Determine the time to progression and objective response rate of this treatment regimen in these patients.\n* Assess the pharmacokinetics of this regimen in these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral SCH 66336 twice a day (starting on day 2 of the first course, and starting on day 1 of all subsequent courses). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 8 weeks until disease progression.\n\nPROJECTED ACCRUAL: A total of 7-31 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed metastatic or unresectable primary transitional cell carcinoma of the urinary tract, including bladder, ureter, and renal pelvis\n* At least one measurable lesion\n\n * 20 mm or greater by conventional techniques OR\n * 10 mm or greater by spiral CT scan\n* Must have received one (and only one) prior chemotherapy regimen for advanced or metastatic disease\n* No clinical signs of brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* At least 3 months\n\nHematopoietic:\n\n* Absolute neutrophil count at least 2,000/mm3\n* Platelet count at least 100,000/mm3\n\nHepatic:\n\n* Bilirubin less than 1.5 times upper limit of normal (ULN)\n* Alkaline phosphatase and transaminases no greater than 2.5 times ULN (no greater than 5 times ULN with liver metastases)\n\nRenal:\n\n* Creatinine no greater than 1.7 mg/dL\n\nCardiovascular:\n\n* Normal cardiac function\n* No ischemic heart disease within the past 6 months\n* Normal 12 lead ECG\n\nOther:\n\n* No prior gastrectomy or any gastrointestinal disease that may impair absorption of SCH 66336\n* No unstable systemic disease\n* No active uncontrolled infection\n* No psychological, familial, sociological, or geographical condition that would preclude study\n* No prior or concurrent other malignancy except cone biopsied carcinoma in situ of the cervix or adequately treated basal or squamous cell skin cancer\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n* At least 4 weeks since prior chemotherapy\n* No prior farnesyl protein transferase inhibitors or gemcitabine\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* At least 4 weeks since prior radiotherapy\n\nSurgery:\n\n* At least 2 weeks since prior major surgery\n\nOther:\n\n* No other concurrent anticancer agents\n* No other concurrent investigational therapy'}, 'identificationModule': {'nctId': 'NCT00006351', 'briefTitle': 'SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'Phase II Study on SCH 66336 (Farnesyl Protein Transferase Inhibitor) and Gemcitabine as Second Line Treatment in Advanced Metastatic Urothelial Cancer - EORTC Study 16997', 'orgStudyIdInfo': {'id': 'EORTC-16997'}, 'secondaryIdInfos': [{'id': 'EORTC-16997'}, {'id': 'EORTC-GU-16997'}, {'id': 'EORTC-PAMM-16997'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'gemcitabine hydrochloride', 'type': 'DRUG'}, {'name': 'lonafarnib', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'University Medical Center Nijmegen', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Ronald De Wit, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Daniel Den Hoed Cancer Center at Erasmus Medical Center'}, {'name': 'Pieter H. M. de Mulder, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitair Medisch Centrum St. Radboud - Nijmegen'}, {'name': 'Godefridus Peters, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Free University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}