Status:
TERMINATED
A Study in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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 chemother...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00082212
Start Date
November 1 2004
End Date
June 1 2007
Last Update
April 9 2010
Active Locations (5)
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1
ImClone Investigational Site
Birmingham, Alabama, United States, 35233
2
ImClone Investigational Site
Orlando, Florida, United States, 32804
3
ImClone Investigational Site
New York, New York, United States, 10021
4
ImClone Investigational Site
Philadelphia, Pennsylvania, United States, 19111