A Study in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
Phase 2
Terminated
- Conditions
- Ovarian Cancer
- Interventions
- Biological: Cetuximab
- Registration Number
- NCT00082212
- Lead Sponsor
- Eli Lilly and Company
- 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 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 25
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Cetuximab 400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles
- Primary Outcome Measures
Name Time Method Overall response rate Every six weeks
- Secondary Outcome Measures
Name Time Method Relationship between response, dose, and occurence of rash Every six weeks
Trial Locations
- Locations (1)
ImClone Investigational Site
🇺🇸Seattle, Washington, United States