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

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

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