Chemotherapy and Radiation Therapy Following Surgery in Treating Patients With Head and Neck Cancer

OBJECTIVES:

• Determine the feasibility of adjuvant paclitaxel followed by radiotherapy with concurrent paclitaxel and cisplatin in patients undergoing gross complete resection of high-risk stage III or IV squamous cell carcinoma of the head and neck.
• Determine the disease-free and overall survival of patients treated with this regimen.
• Determine the acute and chronic toxicity of this regimen in these patients.
• Determine the patterns of failure in patients treated with this regimen.

OUTLINE: Patients receive adjuvant therapy beginning 7-14 days after gross total surgical resection. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Beginning on approximately day 22, patients undergo radiotherapy once daily 5 days a week for 5.5-6.5 weeks. Patients also receive paclitaxel IV over 1 hour followed by cisplatin IV over 1-3 hours on days 43, 50, and 57. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 11 months.

DISEASE CHARACTERISTICS:

• Histologically proven stage III or IV squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx

• Gross total resection completed or planned

• No less than gross total resection
• No disease requiring staging surgery
• Prior gross total resection completed with one or more of the following risk factors:

• Histologically proven multiple lymph node metastases
• At least 1 lymph node with extracapsular extension of tumor
• Positive margin(s) of resection, including mucosal margins and/or soft tissue or deep margins of resection OR
• Gross total resection planned within 14 days of study enrollment with anticipated need for postoperative radiotherapy for one of the following:

• Multiple clinically/radiologically evident lymph nodes of at least 1.5 cm
• Single clinically/radiologically evident lymph node of at least 3 cm
• Histologically proven lymph node metastases
• No T3, N0 glottic cancer
• No nasopharyngeal or paranasal sinus carcinoma
• No distant metastases

PATIENT CHARACTERISTICS:

Age:

• 21 and over

Performance status:

• Zubrod 0-1

Life expectancy:

• Not specified

Hematopoietic:

• White blood cell (WBC) at least 3,000/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) no greater than 1.5 times ULN

Renal:

• Creatinine no greater than 1.5 ULN

Cardiovascular:

• No unstable angina
• No myocardial infarction within the past 6 months unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty
• No uncontrolled arrhythmia
• No second or third degree heart block or other clinically significant conduction system abnormality unless pacemaker is in place

Pulmonary:

• No severe chronic obstructive pulmonary disease requiring 3 or more hospitalizations within the past year

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No pre-existing grade 2 or greater peripheral neurotoxicity
• No other prior malignancy within the past 3 years except low-risk nonmelanomatous skin cancer; carcinoma in situ (e.g., breast, cervix, or bladder); or stage T1-2, low to moderate grade prostate cancer
• No significant wound infection
• No fistula
• No major wound dehiscence
• Nutritional status adequate

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Concurrent colony-stimulating factors for neutropenic fever during study chemoradiotherapy allowed

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• No prior radiotherapy to head and neck

Surgery:

• See Disease Characteristics