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.

Abstract

OBJECTIVE:

The aim of this study was to select the best catumaxomab regimen for further investigation in ovarian cancer based on confirmed tumour response.

METHODS:

Randomised open-label phase IIa study in women with platinum-resistant or -refractory epithelial ovarian cancer. Catumaxomab (6-hour intraperitoneal infusion on days 0, 3, 7 and 10) was administered at a low (10, 10, 10 and 10 μg) or high dose (10, 20, 50 and 100 μg). Responders were patients with either a complete (CR) or partial (PR) response.

RESULTS:

Forty-five patients were randomised to receive either low dose (23) or high dose (22). There were no responders in the low-dose versus one patient (5%) in the high-dose group with a PR. In the low-dose group, two patients (9%) had stable disease compared with five patients (23%) in the high-dose group. Catumaxomab was well tolerated and there was no difference between the dose groups in the incidence of treatment-induced adverse events, the most common of which were gastrointestinal and injection-site reactions.

CONCLUSION:

Catumaxomab had modest activity in platinum-resistant ovarian cancer. The high-dose regimen was associated with a slightly better therapeutic index than the low dose regimen.

• Authors: K Baumann, J Pfisterer, P Wimberger, N Burchardi, C Kurzeder, A du Bois, S Loibl, J Sehouli, J Huober, B Schmalfeldt, I Vergote, H J Lück, U Wagner
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 123 Issue 1 Pg. 27-32 (Oct 2011) ISSN: 1095-6859 [Electronic] United States
• PMID: 21733566 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2011 Elsevier Inc. All rights reserved.

Chemical References

• Antibodies, Bispecific
• Organoplatinum Compounds
• catumaxomab

Topics

• Adult
• Aged
• Aged, 80 and over
• Antibodies, Bispecific (administration & dosage)
• Carcinoma, Ovarian Epithelial
• Disease-Free Survival
• Dose-Response Relationship, Drug
• Drug Resistance, Neoplasm
• Female
• Humans
• Infusions, Parenteral
• Middle Aged
• Neoplasms, Glandular and Epithelial (drug therapy)
• Organoplatinum Compounds (pharmacology)
• Ovarian Neoplasms (drug therapy)