NCT00054054

S0216, Combination Chemotherapy and RT in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT00054054

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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

Summary

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.

Eligibility

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

Disease(s) and\or Condition(s)

Head and Neck Cancer

Primary Purpose

TREATMENT

Intervention/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:

Sponsor

SWOG Cancer Research Network