Panitumumab and Chemotherapy in Patients With Advanced Colorectal Cancer After Prior Therapy With Bevacizumab

PHASE2CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

February 1, 2013

Primary Completion Date

August 6, 2018

Study Completion Date

August 6, 2018

Conditions
Mucinous Adenocarcinoma of the ColonMucinous Adenocarcinoma of the RectumRecurrent Colon CancerRecurrent Rectal CancerSignet Ring Adenocarcinoma of the ColonSignet Ring Adenocarcinoma of the RectumStage IV Colon CancerStage IV Rectal Cancer
Interventions
BIOLOGICAL

panitumumab

Each vial of panitumumab will contain 20 mL of a sterile protein solution containing a 20-mg/mL solution of panitumumab. The vial will contain approximately 400mg of panitumumab and is for single dose use only.

DRUG

irinotecan hydrochloride

Diluted with 5% dextrose (D5W) to a total volume of 500 mL and infused intravenously over 90 minutes. Nothing else should be added to the bag. Patients will be given a dose of 180 mg/M2 by intravenous infusion.

DRUG

fluorouracil

Administered intravenously. A bolus of 400 mg/m2 to be followed by a continuous infusion over 46 hrs at a dose of 2400mg/m2.

DRUG

leucovorin calcium

Leucovorin will be administered at a dose of 200 mg/m2 over 120 minutes prior to the 5-FU bolus. Leucovorin may be run simultaneously with irinotecan infusion via y-site connection.

Trial Locations (2)

37232

Vanderbilt-Ingram Cancer Center, Nashville

43210

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

John Hays

OTHER