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

Fecha de inicio: 1 de abril de 2004

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity or oropharynx * Stage III disease not eligible for surgery * Stage IV disease allowed if patient is not eligible for chemotherapy or refused chemotherapy * No distant metastasis * Previously untreated disease * No osteoradionecrosis in patients with tumors involving the maxilla * Tumor tissue/normal adjacent tissue (T/N) ratio for dC kinase and dCMP deaminase greater than 2.5 PATIENT CHARACTERISTICS: Age * Over 21 Performance status * Karnofsky 80-100% OR * ECOG 0-1 Life expectancy * More than 6 months Hematopoietic * Absolute neutrophil count greater than 1,500/mm\^3 * WBC at least 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic * AST/ALT less than 2.5 times upper limit of normal * Bilirubin normal Renal * Creatinine normal OR * Creatinine clearance greater than 60 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No impending carotid rupture Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study treatment * HIV negative * No other concurrent uncontrolled illness * No active or ongoing infection * No alcohol dependence * No psychiatric illness or social situation that would preclude study compliance * 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) PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy Chemotherapy * See Disease Characteristics * No other concurrent chemotherapy Endocrine therapy * No concurrent hormonal therapy except contraceptives or replacement steroids Radiotherapy * Not specified Surgery * See Disease Characteristics Other * No prior therapy for head and neck cancer * No other concurrent experimental medications * No other concurrent anticancer therapy * No concurrent combination antiretroviral therapy for HIV-positive patients