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

Stopped early · Phase 2

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT00082212

Run by

Eli Lilly and Company

People needed

25

Starts

2004-11-01

Expected to finish

2007-06-01

Last updated by the study team

2010-04-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ImClone Investigational Site — Birmingham, Alabama, United States
• ImClone Investigational Site — Orlando, Florida, United States
• ImClone Investigational Site — New York, New York, United States
• ImClone Investigational Site — Philadelphia, Pennsylvania, United States
• ImClone Investigational Site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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