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 radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cisplatin and radiation therapy in treating patients with stage IV cancer of the head and neck.

Condition	Treatment or Intervention	Phase
stage IV squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the hypopharynx	Drug: cisplatin	Phase II

Further Study Details: 

OBJECTIVES:

I. Determine the percentage of patients for whom a complete course of therapy can be administered using targeted supradose cisplatin chemoradiation in patients with squamous cell carcinoma of the head and neck.

II. Determine the partial and complete response rate of cisplatin chemoradiation.

III. Determine the incidence of adverse events using cisplatin chemoradiation therapy.

IV. Determine the rate of disease-free survival and overall survival in these patients.

V. Determine the incidence and pattern of recurrence in these patients.

VI. Document quality of life measured by disease-specific instruments in these patients.

PROTOCOL OUTLINE:

All patients receive four courses of cisplatin on days 1, 8, 15, and 22 concurrent with radiotherapy. One course of chemotherapy consists of intra-arterial cisplatin given over 3-5 minutes. Radiotherapy is given 5 days a week for 7 weeks. This weekly cisplatin chemoradiation course will be repeated 4 times, providing recovery from toxicity is present.

Dexamethasone is started the evening prior to cisplatin treatment, and continues until the morning following the procedure.

PROJECTED ACCRUAL: 60 patients will be enrolled.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx; No distant metastatic disease; No previous or concurrent head and neck primaries; No lip, nasopharynx, or salivary gland lesions; No recurrent tumors
• Stage IV disease comprised of T4 NO-3 lesions

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: No prior radiotherapy to the head and neck
• Surgery: No prior surgery to study site other than a biopsy
• Other: Protocol treatment must begin within 8 weeks of biopsy

--Patient Characteristics--

• Age: 18 and over
• Performance Status: Karnofsky greater than 60
• Life Expectancy: Not specified
• Hematopoietic: ANC greater than 2,000; Platelet count greater than 100,000
• Hepatic: Not specified
• Renal: Creatinine clearance greater than 50 mL/min
• Cardiovascular: Not specified
• Other: Not pregnant or nursing; No adverse medical illnesses; No imaging studies performed greater than one month preregistration; No laboratory studies greater than 2 weeks preregistration; No other malignancies, except for basal or squamous cell of the skin, within the past 5 years

California
      UCSF Cancer Center and Cancer Research Institute, San Francisco,  California,  94115-0128,  United States
      University of California San Diego Cancer Center, La Jolla,  California,  92093-0658,  United States
Iowa
      University of Iowa Hospitals and Clinics, Iowa City,  Iowa,  52242,  United States
Louisiana
      MBCCOP - LSU Medical Center, New Orleans,  Louisiana,  70112,  United States
Maryland
      Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States
Tennessee
      CCOP - Baptist Cancer Institute, Memphis,  Tennessee,  38117,  United States
      University of Tennessee, Memphis Cancer Center, Memphis,  Tennessee,  38163,  United States
      Vanderbilt Cancer Center, Nashville,  Tennessee,  37232-6838,  United States
Vermont
      Fletcher-Allen Health Care, Burlington,  Vermont,  05401,  United States
      Green Mountain Oncology Group, Rutland,  Vermont,  05701,  United States
Virginia
      Naval Medical Center, Portsmouth, Portsmouth,  Virginia,  23708-2197,  United States
Washington
      University Cancer Center, Seattle,  Washington,  98195,  United States
      University of Washington Neutron Facility and Cancer Center, Seattle,  Washington,  98195,  United States

Study chairs or principal investigators

K. Thomas Robbins,  Study Chair,  Radiation Therapy Oncology Group   

Study ID Numbers:  CDR0000065366; RTOG-9615
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002932
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08