A Phase II Study of Fenretinide in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck
- 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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the response rate, time to progression, median survival, and percent one-year survival
To determine the response rate, time to progression, median survival, and percent one-year survival.
Bonnie S. Glisson, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|