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