Pemetrexed (Alimta) in Patients With Head and Neck Squamous Cell Cancer
Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
- To determine the maximum tolerated doses (MTDs) of pemetrexed when given with
dexamethasone. (Please note: One of the three treatment groups will not receive
dexamethasone)
Secondary Objectives:
- To assess dose limiting toxicity (DLT), which is defined as grade 4 neutropenia > 7 days
duration, neutropenic fever, grade 4 thrombocytopenia, or any grade 3 or 4
non-hematologic toxicity excluding nausea/vomiting and excluding grade 3 transaminase
toxicity.
- To determine objective response rate, as defined as complete response (CR) or partial
response (PR), confirmed by 2 CT scans at least 6 weeks apart in patients treated with
pemetrexed as a single agent with advanced squamous cell carcinoma of the head and neck.