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.