Erlotinib and Chemotherapy for 2nd Line Treatment (Tx) of Metastatic Colorectal Cancer (mCRC)

PHASE2TerminatedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

December 31, 2011

Study Completion Date

December 31, 2011

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

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."

DRUG

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.

DRUG

Leucovorin

Chemotherapy agent given as a supplement to Fluorouracil. Given intravenously 400mg/m2 in combination with Fluorouracil dosing.

DRUG

Oxaliplatin

Platinum-based antineoplastic chemotherapy agent given intravenously at 85 mg/m2.

DRUG

Irinotecan

Chemotherapy agent given intravenously at 180 mg/m2.

Trial Locations (1)

97239

Oregon Health & Science University, Portland

Sponsors
All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

collaborator

OSI Pharmaceuticals

INDUSTRY

lead

OHSU Knight Cancer Institute

OTHER

NCT00642746 - Erlotinib and Chemotherapy for 2nd Line Treatment (Tx) of Metastatic Colorectal Cancer (mCRC) | Biotech Hunter | Biotech Hunter