A Phase II Trial of Single-agent Cetuximab Dose Escalated to Rash in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
Cetuximab
Urogenital Diseases+15
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: November 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
ImClone Investigational Site
Orlando, United StatesImClone Investigational Site
New York, United StatesImClone Investigational Site
Philadelphia, United States