Back to resultsRandomized, 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
Primary Purpose
Ovarian Cancer, Fallopian Tube Neoplasms, Peritoneal Neoplasms
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
anti-EpCAM x anti-CD3 (removab)
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Cancer, Cancer alternative therapies, ovarian cancer
Eligibility Criteria
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
Sites / Locations
- Dept. of Gynecology, University of Marburg
Outcomes
Primary Outcome Measures
Selection of better dose level based on the confirmed tumor response.
Secondary Outcome Measures
Evaluation of safety and tolerability
Effects of removab(TM)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00189345
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AGO Study Group
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Tube Neoplasms, Peritoneal Neoplasms
Keywords
Cancer, Cancer alternative therapies, ovarian cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
anti-EpCAM x anti-CD3 (removab)
Primary Outcome Measure Information:
Title
Selection of better dose level based on the confirmed tumor response.
Secondary Outcome Measure Information:
Title
Evaluation of safety and tolerability
Title
Effects of removab(TM)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uwe Wagner, Prof.Dr.
Organizational Affiliation
AGO Study Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Gynecology, University of Marburg
City
Marburg
ZIP/Postal Code
35037
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
21733566
Citation
Baumann K, Pfisterer J, Wimberger P, Burchardi N, Kurzeder C, du Bois A, Loibl S, Sehouli J, Huober J, Schmalfeldt B, Vergote I, Luck HJ, Wagner U. Intraperitoneal treatment with the trifunctional bispecific antibody Catumaxomab in patients with platinum-resistant epithelial ovarian cancer: a phase IIa study of the AGO Study Group. Gynecol Oncol. 2011 Oct;123(1):27-32. doi: 10.1016/j.ygyno.2011.06.004. Epub 2011 Jul 5.
Results Reference
derived
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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
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