A Phase I/II Study of E7389 Halichondrin B Analog (NSC # 707389; IND # 64395) in Metastatic Urothelial Tract Cancer and Renal Insufficiency
PRIMARY OBJECTIVES:
I. To establish whether E7389 can be given safely to patients with moderate and severe renal
dysfunction at 1.4 mg/m2/week (the MTD previously defined for patients with normal renal
function) on days 1 and 8 of a 21-day cycle. (Phase I) II. To characterize the
pharmacokinetic (PK) profile of E7389 in patients with moderate and severe renal
dysfunction. (Phase I) III. To determine the response rate of patients with advanced
urothelial carcinomas to E7389 in the first-line setting. (Phase II) IV. To determine the
6-month, progression-free survival and overall survival of patients with advanced urothelial
carcinomas treated with E7389. (Phase II) V. To document the toxicity associated with the
administration of E7389 to patients with advanced urothelial carcinoma patients and varying
degrees of renal dysfunction. (Phase II) VI. To determine the response rate of patients with
advanced urothelial carcinomas to E7389 in the setting of progression after prior
platinum-based chemotherapy for advanced or recurrent disease, in two cohorts:
tubulin-inhibitor treated or tubulin-inhibitor naïve. (Tubulin inhibitors in common use for
urothelial cancer include paclitaxel, docetaxel and vinblastine). (Phase II) VII. To
determine the 6-month progression-free survival and overall survival of patients with
advanced urothelial carcinomas treated with E7389 after platinum-based therapy for recurrent
or advanced disease. (Phase II) VIII. To document the toxicity associated with the
administration of E7389 to patients with advanced urothelial carcinoma patients in the
second line and later setting. (Phase II)
OUTLINE: This is a multicenter, dose-escalation, phase I study followed by an open-label
phase II study. Patients in the phase I portion of the study are stratified by renal
dysfunction (moderate vs severe).
PHASE I: Patients receive eribulin mesylate intravenously (IV) over 1-2 minutes on days 1
and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable
toxicity.
PHASE II: Patients receive eribulin mesylate IV over 1-2 minutes on days 1 and 8 at the MTD.
Treatment repeats every 21 days in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed periodically for at least 6
months.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD and RP2D of eribulin mesylate graded according to CTCAE v4.0 (phase I)
21 days
Yes
David Quinn
Principal Investigator
City of Hope Medical Center
United States: Food and Drug Administration
NCI-2009-00170
NCT00365157
October 2006
Name | Location |
---|---|
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Ingalls Memorial Hospital | Harvey, Illinois 60426 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Central Illinois Hematology Oncology Center | Springfield, Illinois 62701 |
City of Hope Medical Center | Duarte, California 91010 |
City of Hope | Duarte, California 91010 |
Contra Costa Regional Medical Center | Martinez, California 94553-3156 |
Tower Cancer Research Foundation | Beverly Hills, California 90211 |
University of Chicago | Chicago, Illinois 60637 |
USC Norris Comprehensive Cancer Center | Los Angeles, California 90089 |
UC Davis Comprehensive Cancer Center | Sacramento, California 95817 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
University of Southern California | Los Angeles, California 90033 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Joliet Oncology-Hematology Associates Limited | Joliet, Illinois 60435 |
Illinois CancerCare-Peoria | Peoria, Illinois 61615 |
Fort Wayne Medical Oncology and Hematology Inc - State Boulevard | Fort Wayne, Indiana 46845 |
Saint John's Mercy Medical Center | Saint Louis, Missouri 63141 |
University of Maryland Greenebaum Cancer Center | Baltimore, Maryland 21201 |
Oncology Care Associates PLLC | St. Joseph, Michigan 49085 |
City of Hope Medical Group Inc | Pasadena, California 91105 |
Community Howard Regional Health | Kokomo, Indiana 46904 |
Veterans Administration Hospital - Martinez | Martinez, California 94553 |
Kellogg Cancer Center - Evanston Hospital | Evanston, Illinois 60201 |
Southern Illinois University School of Medicine - Department of Surgery | Springfield, Illinois 62702 |
UPMC Cancer Center - Pittsburgh | Pittsburgh, Pennsylvania 15241 |