A Single-Arm, Open-Label, Phase II Study to Assess the Safety and Efficacy of the Trifunctional Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) Administered Intraperitoneally in Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites
A multi-center, phase II study of catumaxomab in ovarian cancer patients with recurrent
symptomatic malignant ascites requiring therapeutic paracentesis. Each eligible patient will
receive four ascending doses of catumaxomab, administered intraperitoneally via an
indwelling catheter. 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 7
months (includes the baseline therapeutic paracentesis and screening period, 11 to 21 days
treatment period, and up to 180 days/6 months follow-up), with monthly post-study follow-up
for the lifetime of the patient.
Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The Proportion of Patients Who Achieved at Least a 4-fold Increase of Puncture/Paracentesis-free Interval Following Catumaxomab Relative to Their Pre-treatment Interval.
The parameter to be estimated is the proportion of patients who achieve at least a 4-fold increase in their puncture/paracentesis-free interval. The pretreatment interval is defined as the length of time between the patient's most recent paracentesis (baseline) and the subsequent paracentesis necessitated by her increasing ascites-related symptoms. The post-treatment interval is defined as the time between the last dose of catumaxomab plus 1 day to the time of recurrence of ascites requiring therapeutic paracentesis or death, whichever occurred sooner.
Jonathan Berek, MD MMSc
Stanford University Hospital and Clinics, Department of Obstetrics and Gynecology
United States: Food and Drug Administration
|Huntsman Cancer Institute||Salt Lake City, Utah 84112|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Wayne State University||Detroit, Michigan 48202|
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|University of Miami||Miami, Florida 33136|
|The Methodist Hospital||Houston, Texas 77030|
|Johns Hopkins Medical Institute||Baltimore, Maryland 21231|
|University of Arizona Cancer Center||Tucson, Arizona 85724|
|Northern Indiana Cancer Research Consortium||South Bend, Indiana|
|University of Oklahoma Health Science Center||Oklahoma City, Oklahoma 73104|
|Stanford University Hospital and Clinics||Stanford, California|
|Florida Hospital Cancer Center||Orlando, Florida|
|University of Louisville Cancer Center||Louisville, Kentucky|
|Dartmouth-Hitchock Medical Center||Lebanon, New Hampshire|
|Wake-Forest University||Winston-Salem, North Carolina|
|Magee Women's Hospital, University of Pittsburgh||Pittsburgh, Pennsylvania|
|University of San Diego||La Jolla, California|
|Columbia University Cancer center||New York, New York|