Fallopian Tube Neoplasms, Ovarian Cancer, Peritoneal Neoplasms
Conditions
Keywords
Cancer, Cancer alternative therapies, ovarian cancer
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.
Interventions
BIOLOGICALanti-EpCAM x anti-CD3 (removab)
Sponsors
AGO Study Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Selection of better dose level based on the confirmed tumor response. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of safety and tolerability | — |
| Effects of removab(TM) | — |
Countries
Germany
Outcome results
None listed