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

This study has been terminated.
( Due to lack of sufficient efficacy. )

Sponsors and Collaborators: ImClone Systems
Bristol-Myers Squibb
Information provided by: ImClone Systems
ClinicalTrials.gov Identifier: NCT00082212
  Purpose

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 Intervention Phase
Ovarian Cancer
Biological: Cetuximab
Phase II

MedlinePlus related topics:   Cancer    Ovarian Cancer    Rashes   

Drug Information available for:   Cetuximab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
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

Further study details as provided by ImClone Systems:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relationship between response, dose, and occurence of rash [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]

Enrollment:   25
Study Start Date:   November 2004
Study Completion Date:   June 2007
Primary Completion Date:   June 2007 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
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

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082212

Locations
United States, Alabama
University of Alabama at Birmingham    
      Birmingham, Alabama, United States, 35233
United States, Florida
Florida Hospital Cancer Institute    
      Orlando, Florida, United States, 32804
United States, New York
Memorial Sloan-Kettering Cancer Center    
      New York, New York, United States, 10021
United States, Pennsylvania
Fox Chase Cancer Center    
      Philadelphia, Pennsylvania, United States, 19111
United States, Washington
Pacific Gynecology Specialists    
      Seattle, Washington, United States, 09104

Sponsors and Collaborators
ImClone Systems
Bristol-Myers Squibb

Investigators
Study Chair:     Russell Schilder, MD     Fox Chase Cancer Center    
  More Information


Responsible Party:   ImClone Systems Incorporated ( Eric Rowinsky/ Chief Medical Officer )
Study ID Numbers:   CA225046
First Received:   May 3, 2004
Last Updated:   November 7, 2008
ClinicalTrials.gov Identifier:   NCT00082212
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Cetuximab
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Recurrence
Carcinoma
Genital Diseases, Female
Exanthema
Endocrinopathy
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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