Study of Hepatic Arterial Infusion With Intravenous Irinotecan, 5FU and Leucovorin With or Without Panitumumab, in Patients With Wild Type RAS Who Have Resected Hepatic Metastases From Colorectal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

March 7, 2011

Primary Completion Date

July 15, 2024

Study Completion Date

July 15, 2024

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

panitumumab

"All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.~All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization to panitumumab 6 mg/kg day 15 and 29 Each cycle repeats every 36 days for a total of 6 cycles"

DRUG

Randomization to No Panitumumab

"All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.~All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization (to no panitumumab) Each cycle repeats every 36 days for a total of 6 cycles"

Trial Locations (8)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester, Harrison

11553

Memorial Sloan Kettering Nassau, Uniondale

11570

Memorial Sloan Kettering Rockville Centre, Rockville Centre

11725

Memorial Sloan Kettering Commack, Commack

07920

Memorial Sloan Kettering Basking Ridge, Basking Ridge

07748

Memorial Sloan Kettering Monmouth, Middletown

07645

Memorial Sloan Kettering Bergen, Montvale

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT01312857 - Study of Hepatic Arterial Infusion With Intravenous Irinotecan, 5FU and Leucovorin With or Without Panitumumab, in Patients With Wild Type RAS Who Have Resected Hepatic Metastases From Colorectal Cancer | Biotech Hunter | Biotech Hunter