Carboplatin, Capecitabine, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with carboplatin followed by radiation therapy in treating patients with stage III or stage IV head and neck cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine; Carboplatin

Criteria

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