Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Selection of better dose level based on the confirmed tumor response.
Principal Investigator
Uwe Wagner, Prof.Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
AGO Study Group
Authority:
Germany: Paul-Ehrlich-Institut
Study ID:
AGO-OVAR 2.10
NCT ID:
NCT00189345
Start Date:
May 2004
Completion Date:
October 2005
Related Keywords:
- Ovarian Cancer
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
- Cancer
- Cancer alternative therapies
- ovarian cancer
- Neoplasms
- Fallopian Tube Neoplasms
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Neoplasms, Glandular and Epithelial