Status:
COMPLETED
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)
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
21-120 years
Phase:
PHASE1
Brief Summary
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. D...
Detailed Description
OBJECTIVES: Primary * Determine the dose range of cytochlor to be used in phase II trials, based on safety, toxicity, and tissue selectivity, in patients with advanced squamous cell carcinoma of the...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00077051
Start Date
April 1 2004
End Date
July 1 2007
Last Update
December 15 2016
Active Locations (1)
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1
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136