Ovarian Cancer Clinical Trial

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

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.

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Full 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 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.

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Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT00082212

Recruitment Status:

Terminated

Sponsor:

Eli Lilly and Company

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There are 5 Locations for this study

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ImClone Investigational Site
Birmingham Alabama, 35233, United States
ImClone Investigational Site
Orlando Florida, 32804, United States
ImClone Investigational Site
New York New York, 10021, United States
ImClone Investigational Site
Philadelphia Pennsylvania, 19111, United States
ImClone Investigational Site
Seattle Washington, 09104, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT00082212

Recruitment Status:

Terminated

Sponsor:


Eli Lilly and Company

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