Status:
COMPLETED
Randomized, Multicenter, 2-Dose Level. Open-Label, Phase IIa Study With the Intraperitoneally Infused Trifunctional Bispecific Antibody Removab(TM) (Anti-EpCAM x Anti-CD3) to Select the Better Dose Level in Platinum Refractory Epithelial Ovarian Cancer Patients
Lead Sponsor:
AGO Study Group
Conditions:
Ovarian Cancer
Fallopian Tube Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Patients with epithelial ovarian cancer, fallopian tube or peritoneal cancer who receive surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance of entering comple...
Eligibility Criteria
Inclusion
- women 18 years and older histologically confirmed epithelial ovarian cancer, cancer of the fallopian tube or peritoneum measurable disease signed and dated informed consent one or two prior chemotherapies, the last platinum containing platinum refractory disease ECOG performance status 0-2
Exclusion
- acute or chronic infections previous treatment with mouse monoclonal antibodies known or suspected hypersensitivity to removab inadequate renal function inadequate hepatic function ileus cachectic patients
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00189345
Start Date
May 1 2004
End Date
October 1 2005
Last Update
November 8 2006
Active Locations (1)
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1
Dept. of Gynecology, University of Marburg
Marburg, Germany, 35037