15
Participants
Start Date
September 30, 2007
Primary Completion Date
January 31, 2012
Study Completion Date
October 31, 2012
cisplatin
IP cisplatin will be administered on day 2 of each cycle at 75mg per m2 and IP paclitaxel will be administered at 60mg per m2 on day 8 of each cycle. Courses will be repeated every 21 days for up to 6 cycles
paclitaxel
IP cisplatin will be administered on day 2 of each cycle at 75mg per m2 and IP paclitaxel will be administered at 60mg per m2 on day 8 of each cycle. Courses will be repeated every 21 days for up to 6 cycles
pemetrexed disodium
Escalate doses in groups of 3 patients to 60mg per m2, 120 mg per m2, 500 mg per m2, 750 mg per m2, 1000 mg per m2
biologic sample preservation procedure
Plasma samples will be collected on the 1st course at baseline, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours (if possible) and 24 hours after the first IP Alimta® dose.
Arizona Oncology - Scottsdale, Scottsdale
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson
National Cancer Institute (NCI)
NIH
University of Arizona
OTHER