Phase II Study of Gemcitabine and Docetaxel (GEMDOC) Combination in Patients With Previously Treated Recurrent or Metatstatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- Determine the response rate in patients with previously treated persistent, recurrent,
or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and
- Determine the toxicity of this regimen in these patients.
- Determine the duration of response and survival of patients treated with this regimen.
OUTLINE: Patients receive gemcitabine IV over 30 minutes and docetaxel IV over 60 minutes on
day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable
toxicity. Patients achieving complete response (CR) receive 4 additional courses of therapy
beyond documentation of CR.
After completion of study treatment, patients are followed for survival.
PROJECTED ACCRUAL: A total of 17-41 patients will be accrued within 42-49 months.
Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
Response rate every 2 months
Omer Kucuk, MD
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|Sinai-Grace Hospital||Detroit, Michigan 48235|