16
Participants
Start Date
March 31, 2008
Primary Completion Date
December 31, 2011
Study Completion Date
December 31, 2011
Erlotinib
"Erlotinib oral tablets are conventional, immediate-release tablets containing erlotinib as the hydrochloride salt. In addition to the active ingredient, erlotinib contains lactose (hydrous), microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, and magnesium stearate.~Tablets containing 25 mg, 100 mg, and 150 mg of erlotinib are available. Each bottle will contain 30 tablets, a quantity sufficient for 4 consecutive weeks of dosing, with overage."
Fluorouracil
Antimetabolite used as a chemotherapy. Administered intravenously as a bolus injection at 400mg/m2 on Day 1 followed by 2400 mg/m2 continuously over 46 hours.
Leucovorin
Chemotherapy agent given as a supplement to Fluorouracil. Given intravenously 400mg/m2 in combination with Fluorouracil dosing.
Oxaliplatin
Platinum-based antineoplastic chemotherapy agent given intravenously at 85 mg/m2.
Irinotecan
Chemotherapy agent given intravenously at 180 mg/m2.
Oregon Health & Science University, Portland
Collaborators (2)
Genentech, Inc.
INDUSTRY
OSI Pharmaceuticals
INDUSTRY
OHSU Knight Cancer Institute
OTHER