Jonathan S. Berek
Study of the Trifunctional Antibody Catumaxomab to Treat Recurrent Symptomatic Malignant Ascites
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of this study is to determine whether the investigational drug catumaxomab is a safe and effective treatment for recurrent symptomatic malignant ascites.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: catumaxomab
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- 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 primary platinum-based systemic chemotherapy or progression after at least 2 chemotherapy regimens
- Recurrent symptomatic malignant ascites requiring therapeutic paracentesis
- At least 1 therapeutic paracentesis within 4 weeks prior to baseline paracentesis
- Age >= 18 years
- 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/mm^3 and platelet count >= 75,000/mm^3
- 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.
Key Exclusion Criteria:
- 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 ascite 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
Additional Study Details
Official Title:
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 AscitesAnticipated start date:
1/2/2007Lead Sponsor:
Fresenius Biotech North America, Inc.Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- paracentesis-free interval post-treatment compared to pre-treatment interval
Secondary Outcomes:
- clinical benefit by evaluation of ascites-related signs and symptoms
- safety and tolerability
Total Number to be Enrolled:
38Total Number to be Enrolled at Stanford:
3More Information
Secondary ID(s):
- 97167
- GYNOVA0003
- IP-REM-AC-02-US
- NCT00326885
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
8/24/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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