Evidence map›Paper›PMID 20473913›Full record

Trial reportInternational journal of cancer2010

The trifunctional antibody catumaxomab for the treatment of malignant ascites due to epithelial cancer: Results of a prospective randomized phase II/III trial.

Markus M Heiss, Pawel Murawa, Piotr Koralewski, Elzbieta Kutarska, Olena O Kolesnik, Vladimir V Ivanchenko, Alexander S Dudnichenko, Birute Aleknaviciene, Arturas Razbadauskas, Martin Gore and 10 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of cancer, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 236 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
236citing papers in PubMed, 5 pooled it
42.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00326885 phase2completednot on this map

A Single-Arm, Open-Label, Phase II Study to Assess the Safety and Efficacy of the Trifunctional Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) Administered Intraperitoneally in Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites

TypeinterventionalSponsorNeovii BiotechRan2006 to 2010Enrolled32ConditionsMalignant AscitesArmscatumaxomab
NCT00836654 phase2 / phase3completednot on this map

Two-Arm, Randomized (2:1), Open-Label Phase II/III Study in EpCAM Positive Cancer Patients With Symptomatic Malignant Ascites Using the Trifuncitonal Bispecific Antibody Removab (Anti-EpCAM x Anti-CD3) Versus an Untreated Control Group

TypeinterventionalSponsorNeovii BiotechRan2004 to 2006Enrolled258ConditionsEpCam Positive Tumor (e.g.Ovarian, Gastric, Colon, Breast), Malignant AscitesArmsCatumaxomab (Removab), paracentesis
3 · Its place in the literature

Who cites it

236 citing papers in PubMed, 5 syntheses or guidelines pooled it, 548 citations in OpenAlex.

  1. Pooled it
  2. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer.The Cochrane database of systematic reviews · 2023
    Pooled it
  3. Pooled it
  4. Management of drainage for malignant ascites in gynaecological cancer.The Cochrane database of systematic reviews · 2019
    Pooled it
  5. Antigen-specific active immunotherapy for ovarian cancer.The Cochrane database of systematic reviews · 2018
    Pooled it
  6. Oncolytic adenovirus in treating malignant ascites: A phase II trial and longitudinal single-cell study.Molecular therapy : the journal of the American Society of Gene Therapy · 2024
    Trial
  7. Trial
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  10. A phase II study of catumaxomab administered intra- and postoperatively as part of a multimodal approach in primarily resectable gastric cancer.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2015
    Trial
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  12. Trial
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  17. Trial
  18. Review
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176 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 16 institutions in 6 countries.

Markus M HeissDepartment of Surgery, Cologne-Merheim Medical Center, University of Witten-Herdecke, Cologne, Germany.
Pawel Murawa
Piotr Koralewski
Elzbieta Kutarska
Olena O Kolesnik
Vladimir V Ivanchenko
Alexander S Dudnichenko
Birute Aleknaviciene
Arturas Razbadauskas
Martin Gore
Elena Ganea-Motan
Tudor Ciuleanu
Pauline Wimberger
Alexander Schmittel
Barbara Schmalfeldt
Alexander Burges
Carsten Bokemeyer
Horst Lindhofer
Angelika Lahr
Simon L Parsons
Charité - Universitätsmedizin Berlin · DEGreater Poland Cancer Center · PLInstitute of Oncology Prof. Dr. Ion Chiricuta · ROKharkiv Medical Academy of Postgraduate Education · UALublin Oncology Center · PLNeovii Biotech (Germany) · DENottingham University Hospitals NHS Trust · GBPharmalog (Germany) · DERepublic Klaipeda Hospital · LTRoyal Marsden Hospital · GBSpitalul Clinic de Urgenta Sfantul Ioan · ROTechnical University of Munich · DEUniversität Hamburg · DEUniversity of Duisburg-Essen · DEVilnius University · LTWitten/Herdecke University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Malignant ascites is a common manifestation of advanced cancers, and treatment options are limited. The trifunctional antibody catumaxomab (anti-epithelial cell-adhesion molecule x anti-CD3) represents a targeted immunotherapy for the intraperitoneal (i.p.) treatment of malignant ascites secondary to epithelial cancers. In this phase II/III trial (EudraCT 2004-000723-15; NCT00836654), cancer patients (n = 258) with recurrent symptomatic malignant ascites resistant to conventional chemotherapy were randomized to paracentesis plus catumaxomab (catumaxomab) or paracentesis alone (control) and stratified by cancer type (129 ovarian and 129 nonovarian). Catumaxomab was administered as an i.p. infusion on Days 0, 3, 7 and 10 at doses of 10, 20, 50 and 150 mug, respectively. The primary efficacy endpoint was puncture-free survival. Secondary efficacy parameters included time to next paracentesis, ascites signs and symptoms and overall survival (OS). Puncture-free survival was significantly longer in the catumaxomab group (median 46 days) than the control group (median 11 days) (hazard ratio = 0.254: p < 0.0001) as was median time to next paracentesis (77 versus 13 days; p < 0.0001). In addition, catumaxomab patients had fewer signs and symptoms of ascites than control patients. OS showed a positive trend for the catumaxomab group and, in a prospectively planned analysis, was significantly prolonged in patients with gastric cancer (n = 66; 71 versus 44 days; p = 0.0313). Although adverse events associated with catumaxomab were frequent, they were manageable, generally reversible and mainly related to its immunologic mode of action. Catumaxomab showed a clear clinical benefit in patients with malignant ascites secondary to epithelial cancers, especially gastric cancer, with an acceptable safety profile.

Indexed as

AdultAgedAged, 80 and overAntibodies, BispecificAscitesCombined Modality TherapyDrug Administration ScheduleHumansMiddle AgedNeoplasms, Glandular and EpithelialParacentesisAntibodies, Bispecificcatumaxomab

Identifiers

PMID20473913
PMCPMC2958458
OpenAlexW2038476799

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.