RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses x-rays to damage tumor cells. Drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy and radiation therapy.

PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus cisplatin, paclitaxel, and radiation therapy in treating patients who have advanced unresectable head and neck cancer.

Condition	Treatment or Intervention	Phase
Salivary Gland Cancer lip and oral cavity cancer Head and Neck Cancer Oropharyngeal Cancer	Drug: amifostine  Drug: cisplatin  Drug: paclitaxel	Phase I Phase II

Further Study Details: 

OBJECTIVES: I. Assess the efficacy and role of amifostine as a cytoprotection agent with concurrent chemoradiotherapy in advanced, previously irradiated or metastatic head and neck cancer.

II. Determine the toxicity and response to cisplatin, paclitaxel and radiation therapy in these patients.

III. Determine the toxicity of amifostine in these patients.

PROTOCOL OUTLINE: This is an open label study.

Patients receive paclitaxel by continuous infusion on days 0-3. Amifostine IV is administered over 5 minutes on days 1-5. Radiation therapy is administered once daily on days 1-5. Cisplatin IV is administered on day 5. Patients receive no treatment on days 6-13. Treatment is repeated every 2 weeks for up to 7 courses in the absence of disease progression and unacceptable toxicity.

Patients are followed monthly during the first year, every 2 months during the second year, then every 3 months thereafter.

PROJECTED ACCRUAL: This study will accrue 16-46 patients.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically documented metastatic or previously irradiated recurrent locoregional squamous cell or mucoepidermoid carcinoma of the head and neck
• Unresectable disease

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: At least 1 month since prior chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: At least 3 months since prior radiotherapy (patients with recurrent disease) to head and neck region
• Surgery: Not speciified
• Other: At least 24 hours since antihypertensive medication

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2 OR Karnofsky 70-100%
• Life expectancy: Greater than 4 months
• Hematopoietic: WBC at least 3000/mm3; Platelet count at least 100,000/mm3; Granulocyte count at least 1500/mm3
• Hepatic: Bilirubin no greater than 2.5 times normal; SGOT and SGPT no greater than 2.5 times upper limit of normal
• Renal: Creatinine no greater than 1.5 mg/dL; Creatinine clearance at least 60 mL/min
• Other: No other significant infection; No other medical or psychiatric illness; Not pregnant or nursing; Fertile patients must use effective contraception

Illinois
      University of Illinois at Chicago Health Sciences Center, Chicago,  Illinois,  60612,  United States

Study chairs or principal investigators

Fred R. Rosen,  Study Chair,  University of Illinois   

Study ID Numbers:  CDR0000066133; UIC-H-97-783; NCI-V98-1389; ALZA-UIC-H-97-783
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003251
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08