Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-25 @ 3:06 PM
Study NCT ID:
NCT01191892
Status:
COMPLETED
Last Update Posted:
2019-05-16
First Post:
2010-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carboplatin and Gemcitabine Hydrochloride With or Without Vandetanib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Urinary Tract Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D014516', 'term': 'Ureteral 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': 'D014515', 'term': 'Ureteral Diseases'}, {'id': 'D014522', 'term': 'Urethral Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'C452423', 'term': 'vandetanib'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2016-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-14', 'studyFirstSubmitDate': '2010-08-29', 'studyFirstSubmitQcDate': '2010-08-29', 'lastUpdatePostDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': '1 year', 'description': 'Time to event PFS, follow-up to 1 year'}], 'secondaryOutcomes': [{'measure': 'Tolerability and feasibility', 'timeFrame': '1 year', 'description': 'Rate of randomisation and safety profile of randomised patients'}, {'measure': 'Objective response rate as assessed by RECIST criteria', 'timeFrame': 'Up to 1 year', 'description': 'Proportion of patients responding to treatment'}, {'measure': 'Overall survival', 'timeFrame': '2 years', 'description': 'Patients will be followed up until death by using NHS flagging service.'}, {'measure': 'Change in size of measurable lesions 9 weeks after start of chemotherapy', 'timeFrame': '9 weeks'}, {'measure': 'Toxicity during and after treatment as assessed by NCI CTCAE v 4.0', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['metastatic 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', 'stage III bladder cancer', 'stage IV bladder cancer', 'anterior urethral cancer', 'posterior urethral cancer', 'urethral cancer associated with invasive bladder cancer', 'ureter cancer'], 'conditions': ['Bladder Cancer', 'Transitional Cell Cancer of the Renal Pelvis and Ureter', 'Ureter Cancer', 'Urethral Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vandetanib 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. It is not yet known whether giving carboplatin and gemcitabine hydrochloride is more effective with or without vandetanib as first-line therapy in treating urinary tract cancer.\n\nPURPOSE: This randomized phase II trial is studying giving carboplatin together with gemcitabine hydrochloride and to see how well it works when given with or without vandetanib as first-line therapy in treating patients with locally advanced or metastatic urinary tract cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To determine the antitumor activity (as measured by progression-free survival) of carboplatin and gemcitabine hydrochloride with versus without vandetanib as first-line treatment in patients with locally advanced or metastatic urothelial cell cancer who are not suitable to receive cisplatin.\n\nSecondary\n\n* To determine the safety, feasibility, and tolerability of these regimens in these patients.\n* To determine the objective response rate.\n* To determine the overall survival of patients treated with these regimens\n* To assess the change of size of measurable lesions at 9 weeks of study therapy.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to relevant factors. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive carboplatin IV over 30 minutes on day 1, gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and an oral placebo once daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.\n* Arm II: Patient receive carboplatin and gemcitabine hydrochloride as in arm I. Patients also receive oral vandetanib once daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nBlood and urine samples may be collected for laboratory analysis at baseline and after completion of study.\n\nAfter completion of study treatment, patients are followed up at weeks 18, 26, 39, and 52.\n\nPeer Reviewed and Funded or Endorsed by Cancer Research UK.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed transitional cell carcinoma (pure or mixed histology) of the urothelium (upper or lower urinary tract)\n\n * Cancers with other pathologies are permitted provided the dominant morphology is transitional cell carcinoma\n* Radiologically measurable disease according to RECIST v 1.1 criteria\n* Locally advanced and/or metastatic disease not amenable to curative treatment with surgery or radiotherapy\n* Patient not suitable for cisplatin therapy, meeting 1 or more of the following criteria:\n\n * More than 75 years of age\n * ECOG performance status \\> 2\n * Creatinine clearance \\< 30 mL/min\n * Clinically significant ischemic heart disease (myocardial infarction or unstable angina more than 3 but less than 12 months prior to date of randomization, symptomatic angina, or NYHA class I within 3 months prior to date of randomization)\n * Prior intolerance of cisplatin\n * Any other factor that, in the opinion of the investigator, indicates that cisplatin is not suitable for the patient (e.g., unilateral hearing loss)\n\nPATIENT CHARACTERISTICS:\n\n* See Disease Characteristics\n* ECOG performance status 0-2\n* Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)\n* Creatinine clearance ≥ 30 mL/min\n* Potassium ≥ 4.0 mmol/L OR below the CTCAE grade 1 upper limit\n* Magnesium normal OR below the CTCAE grade 1 upper limit\n* Serum calcium ≤ 2.9 mmol/L (If serum calcium is \\< lower limit of normal \\[LLN\\], then adjusted serum calcium must be ≥ LLN)\n* ALT/AST ≤ 2.5 times ULN\n* Alkaline phosphatase ≤ 2.5 times ULN (\\< 5 times ULN if judged by the investigator to be related to liver metastases)\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective barrier-method contraception during and for 3 months (women) or 2 months (men) after completion of study therapy\n* No evidence of severe or uncontrolled systemic disease or any concurrent condition that, in the investigator's opinion, makes it undesirable for the patient to participate in the trial or that would jeopardize compliance with the protocol\n* No significant risk of cardiac complications, defined as any of the following:\n\n * Clinically significant cardiovascular event (e.g., myocardial infarction, superior vena cava syndrome \\[SVC\\], NYHA classification of heart disease ≥ class II within 3 months prior to entry, or presence of cardiac disease that, in the opinion of the investigator, significantly increases the risk of ventricular arrhythmia)\n * History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) that is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia\n\n * Atrial fibrillation, controlled on medication, is not exclusionary\n* No QTc prolongation with other medications that requires discontinuation of that medication\n* No congenital long QT syndrome or first-degree relative with unexplained sudden death under 40 years of age\n* No QTc that is immeasurable or ≥ 480 msec on screening ECG\n\n * If a patient has a QTc interval ≥ 480 msec on screening ECG, the ECG screen may be repeated twice (at least 24 hours apart) and the average QTc from the three screening ECGs must be \\< 480 msec in order for the patient to be eligible for the study\n * Patients who are receiving a drug that has a risk of Torsades de Pointes are excluded if QTc is ≥ 460 msec\n* No presence of left bundle branch block\n* No hypertension not controlled by medical therapy (systolic blood pressure \\> 160 mm Hg or diastolic blood pressure \\> 100 mm Hg)\n* No currently active diarrhea that, in the investigator's opinion, may affect the ability of the patient to either absorb vandetanib or to tolerate additional diarrhea episodes\n* No previous or current malignancies of other histology within the past 5 years except for carcinoma in situ of the cervix, adequately treated basal cell or squamous cell carcinoma of the skin, or prostate cancer\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* At least 2 weeks since prior and no concurrent known potent CYP3A4 inducers (e.g., barbiturates, rifampicin, rifabutin, phenytoin, carbamazepine, troglitazone, phenobarbital, or St. John wort) or medication that has known adverse interactions with vandetanib\n\n * Dexamethasone (or equivalent) allowed as a pre-medication for chemotherapy\n* At least 4 weeks since prior major surgery and complete surgical wound healing\n* At least 30 days since prior and no other concurrent investigational agents\n* No prior chemotherapy (unless delivered perioperatively and completed \\> 12 months prior to first presentation of recurrent disease)\n* No other concurrent anticancer drug"}, 'identificationModule': {'nctId': 'NCT01191892', 'briefTitle': 'Carboplatin and Gemcitabine Hydrochloride With or Without Vandetanib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Urinary Tract Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cardiff University'}, 'officialTitle': 'A Randomized Phase II Trial of Carboplatin and Gemcitabine +/- Vandetanib in First Line Treatment of Advanced Urothelial Cell Cancer in Patients Who Are Not Suitable to Receive Cisplatin', 'orgStudyIdInfo': {'id': 'CDR0000684016'}, 'secondaryIdInfos': [{'id': 'WCTU-TOUCAN'}, {'id': 'ISRCTN-68146831'}, {'id': 'EUDRACT-2009-010140-33'}, {'id': 'EU-21066'}, {'id': 'CRUK-09/024'}, {'id': 'WCTU-SPON-672-09'}, {'id': 'ZENECA-WCTU-TOUCAN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Carboplatin, Gemcitabine and Placebo', 'interventionNames': ['Drug: carboplatin', 'Drug: gemcitabine hydrochloride', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'vandetanib', 'description': 'Carboplatin, Gemcitabine and vandetanib', 'interventionNames': ['Drug: carboplatin', 'Drug: gemcitabine hydrochloride', 'Drug: vandetanib']}], 'interventions': [{'name': 'carboplatin', 'type': 'DRUG', 'armGroupLabels': ['Placebo', 'vandetanib']}, {'name': 'gemcitabine hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['Placebo', 'vandetanib']}, {'name': 'vandetanib', 'type': 'DRUG', 'armGroupLabels': ['vandetanib']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo of vandetanib tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G12 0YN', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Beatson West of Scotland Cancer Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'CF11 9LJ', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Wales Cancer Trials Unit', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'KA66DX', 'city': 'Ayr', 'country': 'United Kingdom', 'facility': 'Ayr Hospital', 'geoPoint': {'lat': 55.46273, 'lon': -4.63393}}, {'zip': 'BH7 7DW', 'city': 'Bournemouth', 'country': 'United Kingdom', 'facility': 'Royal Bournemouth General Hospital', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'zip': 'DE13 0RB', 'city': 'Burton-on-Trent', 'country': 'United Kingdom', 'facility': 'Queens Hospital', 'geoPoint': {'lat': 52.80728, 'lon': -1.64263}}, {'zip': 'CF142TL', 'city': 'City and County of Cardiff', 'country': 'United Kingdom', 'facility': 'Velindre Hospital'}, {'zip': 'EH4 2XU', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'HX30PW', 'city': 'Halifax', 'country': 'United Kingdom', 'facility': 'Calderdale Royal Infirmary', 'geoPoint': {'lat': 53.71667, 'lon': -1.85}}, {'zip': 'HD3 3EA', 'city': 'Huddersfield', 'country': 'United Kingdom', 'facility': 'Huddersfield Royal Infirmary', 'geoPoint': {'lat': 53.64904, 'lon': -1.78416}}, {'zip': 'LA1 4RP', 'city': 'Lancaster', 'country': 'United Kingdom', 'facility': 'The Royal Lancaster Infirmary', 'geoPoint': {'lat': 54.04649, 'lon': -2.79988}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': "St. James's University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'The Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W21NY', 'city': 'London', 'country': 'United Kingdom', 'facility': 'St Marys Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W68RF', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Charing Cross Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Christie Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'HA6 2RN', 'city': 'Northwood Middlesex', 'country': 'United Kingdom', 'facility': 'Mount Vernon Hospital'}, {'zip': 'OX37LJ', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Churchill Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'S102SJ', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Weston Park Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'S016 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'GU27XX', 'city': 'Surrey', 'country': 'United Kingdom', 'facility': 'Royal Surrey County Hospital'}, {'zip': 'KT2 7QB', 'city': 'Surrey', 'country': 'United Kingdom', 'facility': 'The Royal Marsden Hospital'}], 'overallOfficials': [{'name': 'Robert Jones, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Glasgow'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiff University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}