RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with recurrent or refractory head and neck cancer.

Condition	Treatment or Intervention	Phase
Nose Cancer Oral Cancer	Drug: paclitaxel	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the objective response rate of paclitaxel as salvage therapy in patients with recurrent or refractory head and neck cancer. II. Evaluate the safety of paclitaxel in this patient population. III. Assess the overall survival and quality of life in these patients.

PROTOCOL OUTLINE: This is an open label, multicenter, nonrandomized study. Patients receive intravenous paclitaxel over 1 hour weekly. Each course consists of four weeks. Patients receive treatment until disease progression or unacceptable toxic effects are observed. Patients are followed every 2 months for the first year, then every 4 months until completion of treatment, and then every 3 months until death. Patients complete a quality of life questionnaire prior to each of the first 6 courses, then every 2 courses thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven recurrent or refractory head and neck cancer
• Measurable or evaluable disease
• At least one prior chemotherapy regimen for recurrent or metastatic disease

--Prior/Concurrent Therapy--

• Biologic therapy: At least 3 weeks since prior immunotherapy; No concurrent immunotherapy
• Chemotherapy: See Disease Characteristics; At least 5 weeks since prior nitrosoureas, melphalan, or mitomycin; At least 3 weeks since other prior chemotherapy; Prior taxane therapy allowed only if administered on a 3 week or greater schedule; No concurrent chemotherapy
• Endocrine therapy: At least 3 weeks since prior hormonal therapy; Concurrent megestrol (Megace) allowed; No other concurrent hormonal therapy
• Radiotherapy: At least 3 weeks since prior radiotherapy; No prior radiotherapy to greater than 30% of bone marrow; No concurrent radiotherapy
• Surgery: At least 3 weeks since major surgery
• Other: At least 1 week since prior parenteral antibiotics

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Life expectancy: At least 3 months
• Hematopoietic: Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin no greater than 2 mg/dL; AST or ALT no greater than 2 times upper limit of normal (ULN)
• Renal: Creatinine no greater than 2 times ULN; Calcium within normal limits Cardiovascular: No New York Heart Association class III-IV heart disease; No myocardial infarction within 6 months; No congestive heart failure; No unstable angina; No clinically significant pericardial effusions or arrhythmias
• Neurologic: No peripheral neuropathy greater than grade 1 Other: Not pregnant or nursing; Fertile patients must use effective contraceptive method; Negative pregnancy test; No active infection or serious underlying medical condition; No history of hypersensitivity to drugs containing Cremophor (teniposide, cyclosporine, or vitamin K); No prior invasive malignancies within the past 2 years, except: Curatively treated basal or squamous cell carcinoma of the skin; Carcinoma in situ of the cervix

California
      California Cancer Center, Fresno,  California,  93720,  United States
      Loma Linda University Medical Center, Loma Linda,  California,  92354,  United States
Florida
      Memorial Regional Cancer Center at Memorial Regional Hospital, Hollywood,  Florida,  33021,  United States
      Sylvester Cancer Center, University of Miami, Miami,  Florida,  33136,  United States
Georgia
      Savannah Hematology Oncology Associates, Savannah,  Georgia,  31405,  United States
Illinois
      Decatur Memorial Hospital Cancer Care Institute, Decatur,  Illinois,  62526,  United States
Louisiana
      Mary Bird Perkins Cancer Center, Baton Rouge,  Louisiana,  70809,  United States
Maine
      Maine Center for Cancer Medicine and Blood Disorders, Scarborough,  Maine,  04074,  United States
Maryland
      Johns Hopkins Oncology Center, Baltimore,  Maryland,  21231-2410,  United States
Missouri
      Kansas City Internal Medicine, Kansas City,  Missouri,  64132,  United States
New York
      Lourdes Regional Cancer Center, Binghamton,  New York,  13905,  United States
      Saint Vincent Catholic Medical Center of New York, New York,  New York,  10011,  United States
North Carolina
      Presbyterian Healthcare, Charlotte,  North Carolina,  28233-3549,  United States
Ohio
      Akron City Hospital, Akron,  Ohio,  44309,  United States
      Medical Oncology Hematology Associates, Inc., Dayton,  Ohio,  45409,  United States
Pennsylvania
      Reading Hospital and Medical Center, Reading,  Pennsylvania,  19612-6052,  United States
Texas
      Cancer Care Institute of South Texas, San Antonio,  Texas,  78229,  United States
      Joe Arrington Cancer Research and Treatment Center, Lubbock,  Texas,  79410-1894,  United States
Virginia
      Danville Hematology and Oncology, Inc., Danville,  Virginia,  24541,  United States
Wisconsin
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States

Study chairs or principal investigators

Arlene A. Forastiere,  Study Chair,  Theradex   

Study ID Numbers:  CDR0000066279; THERADEX-B97-5250; NCI-V98-1415; BMS-TAX/MEN.05
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003327
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08