NCT00054054
S0216, Combination Chemotherapy and RT in Treating Patients With Stage III or Stage IV Head and Neck Cancer
PHASE2
COMPLETED
NCT00054054
INTERVENTIONAL
Docetaxel (NSC-628503), Cisplatin (NSC-119875), And 5-Fluorouracil (NSC-19893) Induction Chemotherapy Followed By Accelerated Fractionation/Concomitant Boost Radiation And Concurrent Single Agent Cisplatin (NSC-119875), In Patients With Advanced Squamous Cell Head And Neck Cancer
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 more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients with stage III or stage IV head and neck cancer.
DISEASE CHARACTERISTICS:
* Histologically confirmed squamous cell carcinoma of the head and neck (excluding lip, nasopharynx, paranasal sinus, and salivary gland) by biopsy or fine needle aspirate of the primary lesion or neck mass
* Stage III or IV disease
* No evidence of distant metastases
* Negative chest x-ray
* Primary site in the head and neck region must be identified
* No unknown primary site
* Considered to be appropriate for definitive radiotherapy with curative intent
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-1
Life expectancy
* Not specified
Hematopoietic
* Granulocyte count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic
* Bilirubin no greater than upper limit of normal (ULN)
* Alkaline phosphatase less than 2 times ULN
* ALT or AST less than 1.5 times ULN
Renal
* Creatinine less than 1.5 mg/dL
Cardiovascular
* No myocardial infarction within the past 3 months
* No unstable or uncontrolled angina
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
* No evidence of pre-existing peripheral neuropathy
* No active systemic infection
* No history of hypersensitivity reaction to products containing polysorbate 80
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* No prior radiotherapy
Surgery
* No prior surgery for head or neck cancer
Head and Neck Cancer
- TREATMENT
-
- Type: DRUG
- Name: cisplatin
- Description:
- Arm Group Labels:
-
- Type: DRUG
- Name: docetaxel
- Description:
- Arm Group Labels:
-
- Type: DRUG
- Name: fluorouracil
- Description:
- Arm Group Labels:
-
- Type: RADIATION
- Name: radiation therapy
- Description:
- Arm Group Labels:
- SWOG Cancer Research Network