Study of the Trifunctional Antibody Catumaxomab to Treat Recurrent Symptomatic Malignant Ascites

Completed · Phase 2

Conditions studied: Malignant Ascites

In brief

The purpose of this study is to determine whether the investigational drug catumaxomab is a safe and effective treatment for recurrent symptomatic malignant ascites.

Key facts

Study ID

NCT00326885

Run by

Neovii Biotech

People needed

32

Starts

2006-06-01

Expected to finish

2010-08-01

Last updated by the study team

2018-10-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Signed and dated informed consent
• Histologically confirmed diagnosis of epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer; any stage at diagnosis [International Federation of Gynecology and Obstetrics (FIGO) Stages I through IV].
• Progression on or ≤ 12 months after primary platinum-based systemic or intraperitoneal (IP) chemotherapy OR relapse following reinduction ≥ 12 months after primary chemotherapy.
• Have refused, failed, or have been deemed not suitable candidates for gemcitabine or liposomal doxorubicin.
• Recurrent symptomatic malignant ascites requiring therapeutic paracentesis
• At least 1 therapeutic paracentesis within 4 weeks prior to baseline paracentesis
• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Life expectancy ≥ 16 weeks
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, and total bilirubin ≤ 1.5 x ULN
• Absolute neutrophil count (ANC) ≥ 1,500/mm3 and platelet count ≥ 75,000/mm3
• Negative serum pregnancy test result at screening in women of childbearing potential (applies to patients without documented menopause or sterility).
• Willingness of patients of childbearing potential to use an effective contraceptive method (i.e., oral contraceptive, cervical cap, diaphragm with spermicide, condom with spermicide, or intrauterine device) during the study and for at least 6 months after the last infusion.

You may not qualify if…

• Acute or chronic systemic infection
• Exposure to investigational drugs, chemotherapy or radiotherapy 21 days prior to the first dose of catumaxomab
• Major surgery 2 weeks prior to first dose
• Previous treatment with mouse or rat antibodies
• Known or suspected hypersensitivity to catumaxomab or other monoclonal antibodies
• Body mass index (BMI) < 19 (body weight after paracentesis to be used for calculation of BMI)
• Serum albumin level < 2.0 g/dL
• Reduced nutritional status requiring predominantly parenteral nutrition (> 50% of energy intake). Permanent naso-gastric (NG) feeding tube.
• Ileus in a location that precludes paracentesis
• Extensive liver metastases (> 70% organ volume comprises malignancy)
• Documented brain metastases
• History of myocardial infarction, congestive heart failure or relevant cardiac arrhythmia 3 months prior to the first dose of catumaxomab
• Portal vein obstruction or portal vein thrombosis diagnosed by computed tomography (CT) scan at screening
• Persistent massive pleural effusion or inadequate respiratory function of any other etiology (except if related to ascites symptoms) in the opinion of the investigator
• Any other condition which, according to the investigator, results in an undue risk to the patient by participating in the study
• Prior exposure to catumaxomab

Where it is running

• University of Arizona Cancer Center — Tucson, Arizona, United States
• University of San Diego — La Jolla, California, United States
• Stanford University Hospital and Clinics — Stanford, California, United States
• University of Miami — Miami, Florida, United States
• Florida Hospital Cancer Center — Orlando, Florida, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• University of Louisville Cancer Center — Louisville, Kentucky, United States
• Johns Hopkins Medical Institute — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States
• Dartmouth-Hitchock Medical Center — Lebanon, New Hampshire, United States
• Columbia University Cancer center — New York, New York, United States
• Wake-Forest University — Winston-Salem, North Carolina, United States
• University of Oklahoma Health Science Center — Oklahoma City, Oklahoma, United States
• Magee Women's Hospital, University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• The Methodist Hospital — Houston, Texas, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.