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

Phase 2

Completed

• Conditions: Ovarian Cancer; Fallopian Tube Neoplasms; Peritoneal Neoplasms

• Registration Number: NCT00189345
• Lead Sponsor: AGO Study Group

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 complete clinical remission but about 70% will eventually relapse. Many patients respond to additional cytotoxic treatment with partial or complete responses, yet approximately 100% of these patients will ultimately progress. Novel consolidation strategies following treatment for recurrent disease are needed and an immunologic approach is an attractive option.EpCAM is expressed in a large number of epithelial ovarian cancer, fallopian tube or peritoneal cancer tissues. Thus targeting these cancers with an anti-EpCAM antibody is a promising innovative therapeutic approach.

Detailed Description

Not available

Study Timeline

• Status Verified: 2003-12
• Study Start: 2004-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2005-10
• Last Update Submitted: 2006-11-07
• Last Update Posted: 2006-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

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 Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Selection of better dose level based on the confirmed tumor response.

Secondary Outcome Measures

Name	Time	Method
Evaluation of safety and tolerability
Effects of removab(TM)

Trial Locations

Locations (1)

Dept. of Gynecology, University of Marburg; 🇩🇪 Marburg, Germany