Spots Global Cancer Trial Database for Irinotecan and Cediranib in Treating Patients With Metastatic Colorectal Cancer That Did Not Respond to Previous Oxaliplatin, Fluoropyrimidine, and Bevacizumab
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Trial Identification
Brief Title: Irinotecan and Cediranib in Treating Patients With Metastatic Colorectal Cancer That Did Not Respond to Previous Oxaliplatin, Fluoropyrimidine, and Bevacizumab
Official Title: A Phase II Trial of Irinotecan and AZD2171 in Patients With Metastatic Colorectal Cancer After Progression on First-Line Oxaliplatin, Fluoropyrimidine, and Bevacizumab
Study ID: NCT00588900
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving irinotecan together with cediranib may kill more tumor cells. PURPOSE: This phase II clinical trial is studying how well giving irinotecan together with cediranib works in treating patients with metastatic colorectal cancer that did not respond to previous oxaliplatin, fluoropyrimidine, and bevacizumab.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Evanston Hospital, Evanston, Illinois, United States
Elkhart Clinic, LLC, Elkhart, Indiana, United States
Elkhart General Hospital, Elkhart, Indiana, United States
Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States
Howard Community Hospital, Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend, South Bend, Indiana, United States
Saint Joseph Regional Medical Center, South Bend, Indiana, United States
South Bend Clinic, South Bend, Indiana, United States
Hematology Oncology Associates of the Quad Cities, Bettendorf, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Lakeside Cancer Specialists, PLLC, Saint Joseph, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph, St. Joseph, Michigan, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
Cancer Resource Center - Lincoln, Lincoln, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Immanuel Medical Center, Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center, Omaha, Nebraska, United States
Creighton University Medical Center, Omaha, Nebraska, United States
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care, Concord, New Hampshire, United States
New Hampshire Oncology - Hematology, PA - Hooksett, Hooksett, New Hampshire, United States
Lakes Region General Hospital, Laconia, New Hampshire, United States
CCOP - Hematology-Oncology Associates of Central New York, East Syracuse, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States
Kinston Medical Specialists, Kinston, North Carolina, United States
Rex Cancer Center at Rex Hospital, Raleigh, North Carolina, United States
Iredell Memorial Hospital, Statesville, North Carolina, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Contact Details
Name: Bert H. O'Neil, MD
Affiliation: UNC Lineberger Comprehensive Cancer Center
Role: STUDY_CHAIR
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