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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Trial of Single-agent Cetuximab Dose Escalated to Rash in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Biological: Cetuximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles | Biological: Cetuximab<br>* 400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles<br>* Other names: Erbitux;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | Every six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between response, dose, and occurence of rash |  | Every six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian, primary peritoneal cancer, Persistent or Recurrent Ovarian Cancer, Primary Peritoneal Carcinoma