A Phase II Study of Pemetrexed Plus Gemcitabine for Metastatic/Recurrent Head and Neck Cancer (HNSCC)
Pemetrexed (500 mg/m2) and gemcitabine (1250 mg/m2) will be given together on Days 1 and 15
of a 28 day cycle in patients with recurrent or metastatic head and neck squamous cell
carcinoma (HNSCC). Patients will not have received more than 2 prior chemotherapy regimens
in the recurrent/metastatic disease setting. Vitamin B12 and folate supplementation will be
administered per standard guidelines for pemetrexed chemotherapy.
The primary endpoint is the objective radiologic response rate. Radiologic imaging of
evaluable disease will take place after every 2 cycles. Patients may remain on study until
progression of disease or unacceptable toxicity.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the objective radiologic response rate of pemetrexed + gemcitabine administered q14 days to patients with recurrent or metastatic HNSCC.
David G Pfister, MD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|