[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100063608":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":32,"centralContacts":11,"locations":40,"responsibleParty":53,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":11,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":83,"whyStopped":11,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":70},{"fullName":5,"class":6},"University of Miami","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm","EXPERIMENTAL",null,[13,14,15,16],"Drug: cisplatin","Drug: cytochlor","Drug: tetrahydrouridine","Radiation: radiation therapy",[18,22,25,28],{"type":19,"name":20,"description":11,"armGroupLabels":21,"otherNames":11},"DRUG","cisplatin",[9],{"type":19,"name":23,"description":11,"armGroupLabels":24,"otherNames":11},"cytochlor",[9],{"type":19,"name":26,"description":11,"armGroupLabels":27,"otherNames":11},"tetrahydrouridine",[9],{"type":29,"name":30,"description":11,"armGroupLabels":31,"otherNames":11},"RADIATION","radiation therapy",[9],[33,37],{"name":34,"affiliation":35,"role":36},"Luis E. Raez, MD, FACP","University of Miami Sylvester Comprehensive Cancer Center","STUDY_CHAIR",{"name":38,"affiliation":35,"role":39},"May Abdel-Wahab, MD, PhD","PRINCIPAL_INVESTIGATOR",[41],{"facility":35,"status":11,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":11},"Miami","Florida","33136","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-80.19366,25.77427,{"lat":51,"lon":50},{"type":54,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[56],{"name":57,"class":58},"National Cancer Institute (NCI)","NIH","100063608","phase-1-cytochlor-and-tetrahydrouridine-as-radiosensitizers-and-cisplatin-combined-with-radiation-therapy-in-treating-patients-with-advanced-squamous-cell-carcinoma-of-the-oral-cavity-mouth-or-oropharynx-throat-100063608",false,"NCT00077051","Cytochlor and Tetrahydrouridine as Radiosensitizers and Cisplatin Combined With Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity (Mouth) or Oropharynx (Throat)","Translational Phase I Trial of Escalating Doses of 5-Chloro-2'-Deoxycytidine (CldC) With a Fixed Dose of Tetrahydrouridine Combined With a Fixed Dose of Cisplatin Concomitant With Definitive Radiation in Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity and Oropharynx","DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity or oropharynx\n\n  * Stage III disease not eligible for surgery\n  * Stage IV disease allowed if patient is not eligible for chemotherapy or refused chemotherapy\n  * No distant metastasis\n* Previously untreated disease\n* No osteoradionecrosis in patients with tumors involving the maxilla\n* Tumor tissue\u002Fnormal adjacent tissue (T\u002FN) ratio for dC kinase and dCMP deaminase greater than 2.5\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Over 21\n\nPerformance status\n\n* Karnofsky 80-100% OR\n* ECOG 0-1\n\nLife expectancy\n\n* More than 6 months\n\nHematopoietic\n\n* Absolute neutrophil count greater than 1,500\u002Fmm\\^3\n* WBC at least 3,000\u002Fmm\\^3\n* Platelet count greater than 100,000\u002Fmm\\^3\n\nHepatic\n\n* AST\u002FALT less than 2.5 times upper limit of normal\n* Bilirubin normal\n\nRenal\n\n* Creatinine normal OR\n* Creatinine clearance greater than 60 mL\u002Fmin\n\nCardiovascular\n\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No cardiac arrhythmia\n* No impending carotid rupture\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 6 months after study treatment\n* HIV negative\n* No other concurrent uncontrolled illness\n* No active or ongoing infection\n* No alcohol dependence\n* No psychiatric illness or social situation that would preclude study compliance\n* No other malignancy within the past 3 years except low-risk, non-melanomatous skin cancer, carcinoma in situ (e.g., breast, cervix, or bladder), or stage T1-2, low-to-moderate grade prostate cancer (Gleason score no greater than 7)\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No concurrent immunotherapy\n\nChemotherapy\n\n* See Disease Characteristics\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* No concurrent hormonal therapy except contraceptives or replacement steroids\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* See Disease Characteristics\n\nOther\n\n* No prior therapy for head and neck cancer\n* No other concurrent experimental medications\n* No other concurrent anticancer therapy\n* No concurrent combination antiretroviral therapy for HIV-positive patients","ALL","21 Years","120 Years",{"count":70,"type":71},1,"ACTUAL","INTERVENTIONAL",[74],"PHASE1","RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosensitizing drugs, such as cytochlor and tetrahydrouridine, may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as cisplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Combining radiosensitizers with chemotherapy and radiation therapy may kill more tumor cells.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of cytochlor when given together with tetrahydrouridine, cisplatin and radiation therapy in treating patients with advanced squamous cell carcinoma of the oral cavity (mouth) or oropharynx (throat).",[77],"Head and Neck Cancer",[79,80,81,82],"stage III squamous cell carcinoma of the lip and oral cavity","stage III squamous cell carcinoma of the oropharynx","stage IV squamous cell carcinoma of the lip and oral cavity","stage IV squamous cell carcinoma of the oropharynx","COMPLETED","2016-12-14",{"date":86,"type":87},"2016-12-15","ESTIMATED",{"date":89,"type":11},"2004-04",{"date":91,"type":71},"2007-07",{"name":5,"class":6}]