Fenretinide in Treating Patients With Recurrent or Metastatic 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 fenretinide in treating patients who have recurrent or metastatic head and neck cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Fenretinide in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck|
- To determine the response rate, time to progression, median survival, and percent one-year survival [ Time Frame: one-year survival ] [ Designated as safety issue: Yes ]To determine the response rate, time to progression, median survival, and percent one-year survival.
|Study Start Date:||September 2000|
|Study Completion Date:||July 2004|
|Primary Completion Date:||July 2004 (Final data collection date for primary outcome measure)|
1800 mg/m2 per day for seven consecutive days, in two divided doses of 900 mg/m2 12 hours apart, repeated every 3 weeks.
Other Name: 4-HPR
- Determine the response rate, time to progression, median survival, and percent of 1-year survival in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with fenretinide.
- Determine the pharmacokinetics and safety of this drug in these patients.
OUTLINE: Patients receive oral fenretinide every 12 hours on days 1-7. Treatment repeats every 3 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response continue treatment for 1 year.
PROJECTED ACCRUAL: A total of 16-35 patients will be accrued for this study.
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Bonnie S. Glisson, MD||M.D. Anderson Cancer Center|