Paclitaxel in Treating Patients With Advanced Head and Neck Cancer
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 metastatic head and neck cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Evaluation of Paclitaxel Infusion in Advanced (Recurrent or Metastatic) Squamous Cell Carcinoma of the Head and Neck|
|Study Start Date:||January 1997|
|Primary Completion Date:||September 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Evaluate the response rate and toxic effects of paclitaxel by 96 hour continuous infusion in chemotherapy naive and chemotherapy exposed patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
OUTLINE: Patients receive paclitaxel as a 96 hour continuous IV infusion. Courses repeat every 3 weeks for a maximum of 12 courses. Patients with disease progression after 2 courses or with unacceptable toxicity at any time are removed from study.
PROJECTED ACCRUAL: Approximately 109 patients will be accrued for this study over 4 years.