Phase II Early Postoperative Paclitaxel Followed By Paclitaxel And Cisplatin Concurrent With Radiation Therapy For Resected, High Risk Squamous Carcinoma Of The Head And Neck
Phase II Early Postoperative Paclitaxel Followed By Paclitaxel And Cisplatin Concurrent With Radiation Therapy For Resected, High Risk Squamous Carcinoma Of The Head And Neck
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy following surgery may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have undergone surgery for stage III or stage IV head and neck cancer.
OBJECTIVES:
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
Prior gross total resection completed with one or more of the following risk factors:
Gross total resection planned within 14 days of study enrollment with anticipated need for postoperative radiotherapy for one of the following:
No T3, N0 glottic cancer
No nasopharyngeal or paranasal sinus carcinoma
No distant metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Birmingham, Alabama 35294-3300, United States
Los Angeles, California 90033-0804, United States
Indianapolis, Indiana 46202, United States
Lexington, Kentucky 40536-0084, United States
Baltimore, Maryland 21201, United States
Jamaica Plain, Massachusetts 02130, United States
Mount Holly, New Jersey 08060, United States
Brooklyn, New York 11203, United States
Syracuse, New York 13217, United States
Winston-Salem, North Carolina 27157-1082, United States
Philadelphia, Pennsylvania 19107-5541, United States
St. John's, Newfoundland and Labrador A1B 3V6, Canada