Phase I/Randomized Phase II Study of Second Line Therapy With Irinotecan + Cetuximab +/- RAD001 for Colorectal Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

May 31, 2011

Study Completion Date

February 28, 2015

Conditions
Colorectal Cancer
Interventions
DRUG

Irinotecan

Irinotecan 125 mg/m2 IV days 1 and 8

BIOLOGICAL

Cetuximab

Cetuximab 250mg/m2 IV days 1, 8 and 15

BIOLOGICAL

RAD001

Patients on Arm A will crossover and receive RAD001 at disease progression

Trial Locations (14)

46202

IN Onc/Hem Associates, Indianapolis

Indiana University Simon Cancer Center, Indianapolis

46206

St. Vincent Hospital & Health Centers, Indianapolis

46256

Community Regional Cancer Center, Indianapolis

46321

Monroe Medical Associates, Munster

46601

Northern Indiana Cancer Research Consortium, South Bend

47150

Center for Cancer Care, Inc., P.C., New Albany

47403

Cancer Care Center of Southern Indiana, Bloomington

47714

Oncology Hematology Associates of SW Indiana, Evansville

47904

Arnett Cancer Care, Lafayette

47905

Horizon Oncology Center, Lafayette

60611

Northwestern University Feinberg School of Medicine, Chicago

61401

Medical & Surgical Specialists, LLC, Galesburg

63110

Siteman Cancer Center, St Louis

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

collaborator

Pfizer

INDUSTRY

lead

Hoosier Cancer Research Network

OTHER