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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.)
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
ImClone LLC
ClinicalTrials.gov Identifier:
NCT00082212
First received: May 3, 2004
Last updated: April 8, 2010
Last verified: April 2010

May 3, 2004
April 8, 2010
November 2004
June 2007   (final data collection date for primary outcome measure)
Overall response rate [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00082212 on ClinicalTrials.gov Archive Site
Relationship between response, dose, and occurence of rash [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Study in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
A Phase II Trial of Single-agent Cetuximab Dose Escalated to Rash in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
Biological: Cetuximab
400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles
Other Name: Erbitux
Experimental: 1
400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles
Intervention: Biological: Cetuximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
June 2007
June 2007   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00082212
CA225-046
No
Chief Medical Officer, ImClone LLC
ImClone LLC
Bristol-Myers Squibb
Study Chair: E-mail: ClinicalTrials@ ImClone.com ImClone LLC
ImClone LLC
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP