Status:
COMPLETED
Carboplatin, Capecitabine, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Ra...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose (MTD) of capecitabine when administered with carboplatin as induction chemotherapy in patients with stage III-IVB squamous cell carcinoma o...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the head and neck, including 1 of the following types:
- Oral cavity
- Oropharynx
- Hypopharynx
- Clinical stage III-IVB (T2-T4, N0-N3, M0) disease
- Measurable disease by physical exam, endoscopy, and/or CT scan or MRI
- Residual measurable disease after fine needle aspiration, core needle biopsy, or incisional or excisional biopsy of the primary tumor
- No evidence of distant metastases (M1)
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Zubrod 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count \> 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Hemoglobin \> 9 g/dL
- No uncontrolled coagulopathy
- Hepatic
- AST \< 2 times normal
- Alkaline phosphatase \< 2 times normal
- Bilirubin normal
- Renal
- Creatinine \< 2.0 mg/dL OR
- Creatinine clearance \> 50 mL/min
- Cardiovascular
- No congestive heart failure
- No symptomatic coronary artery disease
- No uncontrolled cardiac arrhythmias
- No myocardial infarction within the past year
- No other clinically significant cardiac disease
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 30 days after completion of study treatment
- Nutritional and general physical condition must be compatible with proposed study treatment
- Mentally reliable
- No pre-existing peripheral neuropathy \> grade 1
- No history of hypersensitivity to fluorouracil, capecitabine, or carboplatin
- No active infection
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- No major medical, psychiatric, or neurologic illness that would preclude study participation or giving informed consent
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- More than 5 years since prior chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- No prior radiotherapy for head and neck tumor
- No prior radiotherapy to the region of planned study radiotherapy fields
- Surgery
- Recovered from prior surgery
- No unhealed surgical wounds
- Other
- More than 4 weeks since prior investigational drugs
- No concurrent warfarin, diphenylhydantoin, or fluconazole unless willing to undergo careful monitoring and appropriate dose adjustments
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00114153
Start Date
June 1 2003
Last Update
November 26 2009
Active Locations (1)
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1
University of Virginia Cancer Center at UV Health System
Charlottesville, Virginia, United States, 22908