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

Lilly

Status and phase

Terminated

Phase 2

Conditions

Ovarian Cancer

Treatments

Biological: Cetuximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00082212

CA225-046

Details and patient eligibility

About

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.

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.

Enrollment

25 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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