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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Fallopian Tube Neoplasms, Peritoneal Neoplasms

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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

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