drugset / Trial / NCT00507858
Pemetrexed (Alimta) in Patients With Head and Neck Squamous Cell Cancer
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2005-09
- Primary completion
- 2011-09
- Completion
- 2011-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 4 mg | Intravenous |
| Subject | Dexamethasone | Small molecule | 20 mg | Intravenous |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |