A Phase II Trial of Irinotecan and AZD2171 in Patients With Metastatic Colorectal Cancer After Progression on First-Line Oxaliplatin, Fluoropyrimidine, and Bevacizumab
OBJECTIVES:
Primary
- To determine the proportion of patients who are free from progression at 12 weeks from
the start of second-line therapy.
Secondary
- To determine objective response rate.
- To determine overall survival.
- To further define the dosing and safety profile of irinotecan hydrochloride and
cediranib.
OUTLINE: This is a multicenter study.
Patients receive irinotecan hydrochloride IV over 90 minutes on days 1 and 8 and oral
cediranib once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in
the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for up to 2 years
from study entry.
Interventional
Masking: Open Label, Primary Purpose: Treatment
The proportion of patients who are progression-free at 12 weeks from the start of second-line therapy
No
Bert H. O'Neil, MD
Study Chair
UNC Lineberger Comprehensive Cancer Center
United States: Federal Government
CDR0000580967
NCT00588900
March 2008
Name | Location |
---|---|
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
Hematology Oncology Associates of the Quad Cities | Bettendorf, Iowa 52722 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Howard Community Hospital | Kokomo, Indiana 46904 |
South Bend Clinic | South Bend, Indiana 46617 |
Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
Fort Wayne Medical Oncology and Hematology | Fort Wayne, Indiana 46815 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Immanuel Medical Center | Omaha, Nebraska 68122 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Iredell Memorial Hospital | Statesville, North Carolina 28677 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
Evanston Hospital | Evanston, Illinois 60201-1781 |
Elkhart Clinic, LLC | Elkhart, Indiana 46514-2098 |
Michiana Hematology-Oncology, PC - South Bend | Mishawaka, Indiana 46545-1470 |
Lakeside Cancer Specialists, PLLC | Saint Joseph, Michigan 49085 |
Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Rex Cancer Center at Rex Hospital | Raleigh, North Carolina 27607 |
Kinston Medical Specialists | Kinston, North Carolina 28501 |
Lakes Region General Hospital | Laconia, New Hampshire 03246 |
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | Concord, New Hampshire 03301 |
New Hampshire Oncology - Hematology, PA - Hooksett | Hooksett, New Hampshire 03106 |