A Study in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

A Phase II Trial of Single-agent Cetuximab Dose Escalated to Rash in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

The purpose of this study is to determine the overall response rate, time to progression, and 1 yr survival with cetuximab in patients with ovarian or primary peritoneal carcinoma.

To determine the overall response rate of cetuximab alone in subjects with ovarian or primary peritoneal carcinoma who have persistent or recurrent disease following 1-2 previous regimens of chemotherapy. Potential relationship between response, dose, and the occurence of rash in the treatment of subjects who have stable disease after the initial 6 weeks of treatment, time to progression, and 1 yr survival.

Inclusion Criteria:

• subjects must have recurrent or persistent epithelial ovarian or primary peritoneal carcinoma. Histologic confirmation of the original primary tumor is required.
• EGFR expression must be positive as determined by an outside reference lab
• Subjects must have had a treatment-free interval following platinum of <12 mos
• All subjects must have measurable disease at baseline
• Subjects must have at least one recurrent lesion to be used to assess response
• Recovery from effect of recent surgery, radiotherapy or chemotherapy

Exclusion Criteria:

• Subjects with other invasive malignancies (including peritoneal mesotheliomas)
• Subjects with unstable cardiac disease or MI within 6 mos
• Subjects with Acute hepatitis
• Subjects with active or uncontrolled infection
• A history of prior cetuximab or other therapy which targets the EGFR pathway or prior history of prior chimerized or murine monoclonal antibody therapy