Phase II Trial of SU5416 (NSC #696819) in Patients With Advanced Colorectal Cancer
I. Determine the objective response rate and disease stabilization rates of patients with
previously treated metastatic or locally recurrent colorectal cancer treated with SU5416.
II. Determine the median and overall survival and time to progression in this patient
population receiving this treatment.
III. Determine the toxicity of SU5416 in these patients.
OUTLINE: This is a multicenter study.
Patient receive SU5416 IV over 60 minutes twice weekly for 4 weeks. Treatment continues for
a minimum of 2 courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 2 weeks for 4 weeks.
PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study within 12-18
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Hedy L. Kindler, MD
University of Chicago
United States: Food and Drug Administration
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Evanston Northwestern Health Care||Evanston, Illinois 60201|
|Louis A. Weiss Memorial Hospital||Chicago, Illinois 60640|
|University of Illinois at Chicago||Chicago, Illinois 60612|
|Cancer Care Specialists of Central Illinois, S.C.||Decatur, Illinois 62526|
|Oncology/Hematology Associates of Central Illinois, P.C.||Peoria, Illinois 61602|
|Central Illinois Hematology Oncology Center||Springfield, Illinois 62701|
|Fort Wayne Medical Oncology and Hematology, Inc.||Fort Wayne, Indiana 46885-5099|
|Michiana Hematology/Oncology P.C.||South Bend, Indiana 46617|
|Division of Hematology/Oncology||Park Ridge, Illinois 60068|