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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: paclitaxel
* Procedure: conventional surgery
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgery, chemotherapy and radiation therapy<br>Early post-operative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy for resected head and neck cancer. | Drug: cisplatin<br> <br> Drug: paclitaxel<br> <br> Procedure: conventional surgery<br> <br> Radiation: radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient tolerance of the treatment regimen |  | From registration to end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of grade 5 and acute non-hematologic grade 4 toxicity |  | From start of induction chemotherapy to 90 days after start of radiation therapy | 
| Frequency of other acute and late toxicity |  | From start of induction chemotherapy to last follow-up | 
| Local-regional control |  | From registration to date of failure (local or regional progression) or death or last follow-up. Analysis occurs after patients have been followed for at least 2 years. | 
| Disease-free survival |  | From registration to date of failure (local, regional, or distant progression, or second primary or death) or last follow-up. Analysis occurs after patients have been followed for at least 2 years. | 
| Overall survival |  | From registration to date of death or last follow-up. Analysis occurs after patients have been followed for at least 2 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx