A Study in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma - Full Text View

Sponsor:	ImClone LLC
Collaborator:	Bristol-Myers Squibb
Information provided by:	ImClone LLC
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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer Rashes

Drug Information available for: Cetuximab

U.S. FDA Resources

Further study details as provided by ImClone LLC:

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
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

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
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

Investigators

Study Chair:

E-mail: ClinicalTrials@ ImClone.com

ImClone LLC

More Information

No publications provided

Responsible Party:	Chief Medical Officer, ImClone LLC
ClinicalTrials.gov Identifier:	NCT00082212 History of Changes
Other Study ID Numbers:	CA225-046
Study First Received:	May 3, 2004
Last Updated:	April 8, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by ImClone LLC:

ovarian
primary peritoneal cancer
Persistent or Recurrent Ovarian Cancer
Primary Peritoneal Carcinoma

Additional relevant MeSH terms:

Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases

Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012