AzTrials
AzTrials

Ovarian CancerPhase 2NCT00189345

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

A Phase 2 study testing anti-EpCAM x anti-CD3 (removab) in people with Ovarian Cancer and Fallopian Tube Neoplasms, run by AGO Study Group at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
anti-EpCAM x anti-CD3 (removab)
How many people
44 participants
Where
1 siteGermany
Study dates
May 2004to Oct 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Dept. of Gynecology, University of Marburg

    Marburg, 35037

Other trials in Germany

About this study

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.

Being tested
anti-EpCAM x anti-CD3 (removab)
Keywords
Cancer, Cancer alternative therapies, ovarian cancer
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anti-EpCAM x anti-CD3 (removab)Biological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Selection of better dose level based on the confirmed tumor response.

Secondary outcomes (2)

  1. Evaluation of safety and tolerability

  2. Effects of removab(TM)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2005 (estimated)
  2. Study startMay 2004
  3. Study completionOct 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00189345
Sponsor's protocol ID
AGO-OVAR 2.10
Status last verified
Dec 2003
First submitted
12 Sep 2005
Last updated
8 Nov 2006
Results posted
No

Publications

  • 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.

    PubMed 21733566

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anti-EpCAM x anti-CD3 (removab) in people with Ovarian Cancer and Fallopian Tube Neoplasms, run by AGO Study Group at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Selection of better dose level based on the confirmed tumor response.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00189345, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2006.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in