A Phase II Trial of MGI-114 (NSC# 683863) Administered as a 5-Minute Infusion Daily for Five Days Every 4 Weeks in Patients With Previously Untreated Advanced Colorectal Cancer
OBJECTIVES: I. Determine the objective response rate of patients with metastatic or locally
recurrent adenocarcinoma of the colon or rectum treated with 6-hydroxymethylacylfulvene
(MGI-114). II. Determine the toxicity of this treatment regimen in this patient population.
III. Study pharmacokinetics of MGI-114 in these patients. IV. Determine the relationship
between pharmacokinetics of MGI-114 and clinical outcomes including toxicity and response to
therapy in these patients.
OUTLINE: This is an open label, multicenter study. Patients receive
6-hyroxymethylacylfulvene (MGI-114) IV over 5 minutes daily for 5 days. Courses are repeated
every 4 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable
toxic effects or disease progression. Patients are followed until death.
PROJECTED ACCRUAL: A total of 14-35 patients will be accrued for this study within 6-12
months.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical Response Rate
3 years
No
Hedy L. Kindler, MD
Study Chair
University of Chicago
United States: Federal Government
9635
NCT00003786
April 1999
November 2000
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Lutheran General Cancer Care Center | Park Ridge, Illinois 60068 |
James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
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 |
Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne, Indiana 46885-5099 |
Michiana Hematology/Oncology P.C. | South Bend, Indiana 46617 |
Illinois Oncology Research Association | Peoria, Illinois 61602 |