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A Phase II Study in Patients with Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma



A Phase II Study in Patients with Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

For Condition: Primary Peritoneal Carcinoma,Persistent or Recurrent Ovarian Cancer
Status: Not yet recruiting
Sponsor(s): Bristol-Myers Squibb , ImClone Systems
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry 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 measureable 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
Total Enrollment: 50

Location and Contact Information:

Memorial Sloan-Kettering Cancer Center
New York City,  New York,  10021
United States
Carol  Aghajanian 212-639-2252

Fox Chase Cancer Center
Philadelphia,  Pennsylvania,  19111
United States
Russell  Schilder 215-728-3545

M.D. Anderson Cancer Center
Houston,  Texas,  77030
United States
David  Gershenson 713-745-2565

Pacific Gynecology Specialists
Seattle,  Washington,  09104
United States
Charles  Drescher 206-215-3200

University of Alabama at Birmingham
Birmingham,  Alabama,  35233
United States
Ronald  Alvarez 205-975-6714


Additional Information:
Study ID Numbers:
  CA225-046; 
Study Start Date: 
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082212

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