RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine together with paclitaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel works in treating patients with persistent, recurrent, or metastatic head and neck cancer.

Condition	Treatment or Intervention	Phase
Head and Neck Cancer	Drug: gemcitabine  Drug: paclitaxel  Procedure: chemotherapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine overall and progression-free survival probability in patients with persistent, recurrent, or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and paclitaxel.
• Determine the confirmed and unconfirmed response (partial and complete) probability in patients with measurable disease treated with this regimen.
• Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.

Patients are followed every 8 weeks until disease progression, every 6 month for 2 years, and then annually for 1 year.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 10-13 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN)
• Recurrent, persistent, or newly diagnosed metastatic disease
• Measurable or non-measurable disease
• No active or prior CNS metastasis

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• No serious organ dysfunction
• No serious comorbid conditions that would preclude study treatment
• No history of hypersensitivity reaction to products containing polysorbate 80
• No active infection requiring systemic antibiotic therapy
• No symptomatic sensory neuropathy ≥ grade 2
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy

• No concurrent biologic or immunotherapy for SCCHN
• No concurrent gene therapy for SCCHN

Chemotherapy

• No prior chemotherapy for recurrent or newly diagnosed metastatic disease
• At least 6 months since prior induction or adjuvant chemotherapy
• No more than 1 prior induction or adjuvant regimen
• No prior gemcitabine or taxanes as part of induction, adjuvant, or neoadjuvant chemotherapy
• No other concurrent chemotherapy for SCCHN

Endocrine therapy

• Not specified

Radiotherapy

• At least 28 days since prior radiotherapy and recovered
• No concurrent radiotherapy for SCCHN

Surgery

• Not specified

Other

• No other concurrent therapy for SCCHN

Kansas
      Salina Regional Health Center, Salina,  Kansas,  67401,  United States; Recruiting

Study chairs or principal investigators

Omer Kucuk, MD,  Barbara Ann Karmanos Cancer Institute   
Richard H. Wheeler, MD,  University of Utah   

Study ID Numbers:  CDR0000407644; SWOG-S0329; NCT00100789
Record last reviewed:  February 2005
Last Updated:  March 3, 2005
Record first received:  January 6, 2005
ClinicalTrials.gov Identifier:  NCT00100789
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08