A phase II trial of EMD72000 (matuzumab), a humanized anti-EGFR monoclonal antibody, in patients with platinum-resistant ovarian and primary peritoneal malignancies.

Abstract

OBJECTIVE:

The primary objective of this study was to determine the rate of response to matuzumab in patients with recurrent, EGFR-positive ovarian, or primary peritoneal cancer. Secondary end points included safety and tolerability, time to tumor progression, duration of response, and overall survival.

METHODS:

A multi-institutional single arm phase II trial.

RESULTS:

Of 75 women screened for the study, 37 were enrolled and treated. Median age of the treated patient population was 58 years, and most patients had more than four prior lines of chemotherapy. Therapy was well tolerated, the most common toxicities being a constellation of skin toxicities, including rash, acne, dry skin, and paronychia, as well as headache, fatigue, and diarrhea. Serious adverse events were very rare but included a single episode of pancreatitis that may have been drug related. All patients completed therapy, receiving 1 to 30 infusions of matuzumab. There were no formal responses (RR=0%, 95% CI: 0-9.5%), although 7 patients (21%) were on therapy for more than 3 months with stable disease.

CONCLUSIONS:

Matuzumab at the dose and schedule selected is well tolerated. In this population of very heavily pretreated patients with epithelial ovarian and primary peritoneal malignancies, there was no evidence of significant clinical activity when matuzumab was administered as monotherapy.

• Authors: M V Seiden, H A Burris, U Matulonis, J B Hall, D K Armstrong, J Speyer, J D A Weber, F Muggia
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 104 Issue 3 Pg. 727-31 (Mar 2007) ISSN: 0090-8258 [Print] United States
• PMID: 17126894 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Antineoplastic Agents
• Organoplatinum Compounds
• ErbB Receptors
• Cetuximab

Topics

• Adult
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal (therapeutic use)
• Antibodies, Monoclonal, Humanized
• Antineoplastic Agents (therapeutic use)
• Cetuximab
• Drug Resistance, Neoplasm
• ErbB Receptors (biosynthesis, immunology)
• Female
• Humans
• Middle Aged
• Organoplatinum Compounds (pharmacology)
• Ovarian Neoplasms (drug therapy, enzymology, immunology)
• Peritoneal Neoplasms (drug therapy, immunology)