An Open-Label, Single-Arm, Phase II Safety and Tolerability Study of Catumaxomab (Anti-EpCAM x Anti-CD3) in Women With Advanced Epithelial Ovarian Cancer After a Complete Response to Chemotherapy
A multi-center, phase II study of catumaxomab in ovarian cancer patients who experience a
complete response to chemotherapy. Each eligible patient will receive four ascending doses
of catumaxomab, administered intraperitoneally via an indwelling catheter or port.
Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval
of 3-4 days. Each patient will participate in this study for up to 4 months (includes the
baseline screening period, 11 to 21 days treatment period, and up to 90 days/3 months
follow-up), with post-study follow-up every 3 months for 2 years.
Catumaxomab is a trifunctional antibody targeting epithelial cell adhesion molecule (EpCAM)
on tumor cells and CD3 (cluster of differentiation 3) on T cells. Trifunctional antibodies
represent a new concept for targeted anticancer therapy. This new antibody class has the
capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells [DCs]
and natural killer [NK] cells) to the tumor site. According to preclinical data,
trifunctional antibodies activate these different immune effector cells, which can trigger a
complex anti-tumor immune response.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants Who Completed a 4-dose Series of Catumaxomab Infusions (Defined as 10-20-50-150 Micrograms) Within 21 Days
21 days
Yes
Michael V Seiden, MD, Ph.D
Principal Investigator
Massachusetts General Hospital
United States: Food and Drug Administration
IP-CAT-OC-01
NCT00377429
September 2006
February 2008
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
Florida Hospital Cancer Institute | Orlando, Florida 32804 |
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
South Carolina Oncology Associates | Columbia, South Carolina 29201 |
University of New Mexico | Albuquerque, New Mexico 87131 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
Stanford University of Obstetrics and Gynecology | Stanford, California 94305 |
Gynecologic Oncology - Hinsdale | Hinsdale, Illinois 60521 |
Michiana Hematology Oncology P.C. | South Bend, Indiana 46617 |
Magee-Women Hospital of UPMC | Pittsburg, Pennsylvania 15213 |