A Randomized Phase II Study of Irinotecan and Cetuximab With or Without the Anti-Angiogenic Antibody, Ramucirumab (IMC-1121B), in Advanced, K-ras Wild-Type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy
A Randomized Phase II Study of Irinotecan and Cetuximab With or Without the Anti-Angiogenic Antibody, Ramucirumab (IMC-1121B), in Advanced, K-ras Wild-Type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy
RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and ramucirumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab and ramucirumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not yet know whether giving cetuximab and irinotecan hydrochloride together is more effective with or without ramucirumab in treating colorectal cancer.
PURPOSE: This randomized phase II trial is studying the side effects and how well giving cetuximab and irinotecan hydrochloride with or without ramucirumab work in treating patients with advanced colorectal cancer with progressive disease after treatment with bevacizumab-containing chemotherapy.
OBJECTIVES:
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to performance status (0 vs 1), discontinuation of oxaliplatin before disease progression (yes vs no), and time to disease progression since last treatment (≤ 6 months vs > 6 months). Patients are randomized to 1 of 2 treatment arms.
In all arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up periodically for 5 years.
Inclusion Criteria:
Exclusion Criteria:
Grand Junction, Colorado 81502, United States
Hartford, Connecticut 06105, United States
Savannah, Georgia 31405, United States
Chicago, Illinois 60611-3013, United States
Libertyville, Illinois 60048, United States
Moline, Illinois 61265, United States
Peoria, Illinois 61615, United States
Indianapolis, Indiana 46202-5289, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
Wichita, Kansas 67214, United States
Springfield, Massachusetts 01199, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
Flemington, New Jersey 08822, United States
Albuquerque, New Mexico 87110, United States
Harrisburg, Pennsylvania 17110-2098, United States
Philadelphia, Pennsylvania 19104-4283, United States
Philadelphia, Pennsylvania 19107-5541, United States
Reading, Pennsylvania 19612-6052, United States
Scranton, Pennsylvania 18508, United States
Wilkes-Barre, Pennsylvania 18711, United States
Sioux Falls, South Dakota 57117-5039, United States
Dallas, Texas 75390, United States
Charleston, West Virginia 25304, United States
Green Bay, Wisconsin 54311, United States
Madison, Wisconsin 53792-6164, United States
Manitowoc, Wisconsin 54221-1450, United States
Summit, Wisconsin 53066, United States
Wausau, Wisconsin 54401, United States