Head and Neck Cancer Clinical Trial
Official title:
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
Verified date | December 2016 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
PURPOSE: 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).
Status | Completed |
Enrollment | 1 |
Est. completion date | July 2007 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 120 Years |
Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami | National Cancer Institute (NCI) |
United States,
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