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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00082212
Recruitment Status : Terminated (Due to lack of sufficient efficacy.)
First Posted : May 5, 2004
Last Update Posted : April 9, 2010
Bristol-Myers Squibb
Information provided by:
ImClone LLC

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Biological: Cetuximab Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Single-agent Cetuximab Dose Escalated to Rash in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
Study Start Date : November 2004
Primary Completion Date : June 2007
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles
Biological: Cetuximab
400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles
Other Name: Erbitux

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: Every six weeks ]

Secondary Outcome Measures :
  1. Relationship between response, dose, and occurence of rash [ Time Frame: Every six weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082212

United States, Alabama
ImClone Investigational Site
Birmingham, Alabama, United States, 35233
United States, Florida
ImClone Investigational Site
Orlando, Florida, United States, 32804
United States, New York
ImClone Investigational Site
New York, New York, United States, 10021
United States, Pennsylvania
ImClone Investigational Site
Philadelphia, Pennsylvania, United States, 19111
United States, Washington
ImClone Investigational Site
Seattle, Washington, United States, 09104
Sponsors and Collaborators
ImClone LLC
Bristol-Myers Squibb
Study Chair: E-mail: ClinicalTrials@ ImClone.com ImClone LLC

Responsible Party: Chief Medical Officer, ImClone LLC
ClinicalTrials.gov Identifier: NCT00082212     History of Changes
Other Study ID Numbers: CA225-046
First Posted: May 5, 2004    Key Record Dates
Last Update Posted: April 9, 2010
Last Verified: April 2010

Keywords provided by ImClone LLC:
primary peritoneal cancer
Persistent or Recurrent Ovarian Cancer
Primary Peritoneal Carcinoma

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Antineoplastic Agents