A Trial of Erbitux for Recurrent and Metastatic Mucinous Gastrointestinal Adenocarcinoma Involving the Peritoneal Surfaces

This study has been completed.

First Received: September 9, 2005 Last Updated: June 27, 2008 History of Changes

Sponsors and Collaborators:	Bristol-Myers Squibb ImClone LLC
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00162110

Purpose

This is a Phase II open-label trial evaluating the efficacy, and safety of Erbitux in patients with mucinous gastrointestinal adenocarcinoma involving the peritoneal surface.

Condition	Intervention	Phase
Mucinous Gastrointestinal Adenocarcinoma	Drug: cetuximab	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Trial of Erbitux for Recurrent and Metastatic Mucinous Gastrointestinal Adenocarcinoma Involving the Peritoneal Surfaces

Resource links provided by NLM:

Drug Information available for: Cetuximab

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Evaluate the efficacy of Erbitux in the treatment of mucinous gastrointestinal adenocarcinoma involving the peritoneal surfaces based on clinical response rate.

Secondary Outcome Measures:

To evaulate surgically resected tumor specimens of the EGF receptor, mucins 1-6, and anglogenic indices such as vessel counts, VEGF expression, and Ki-67 expression. To evaluate the safety of Erbitux monotherapy in this patient population.

Estimated Enrollment:	40
Study Start Date:	November 2004
Study Completion Date:	January 2007

Arms	Assigned Interventions
1: Active Comparator	Drug: cetuximab mg, IV, 225 mg/m2, weekly, 4-52 weeks depending on response.

Eligibility

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

Criteria

Inclusion Criteria:

Able to take care of self. Out of bed less than 50% of the day
Absolute neutrophil count >=1,500
Platelet count >=100,000
Total bilirubin count <=1.5 times the upper limit of normal

Exclusion Criteria:

Prior epidermal growth factor receptor antibody
Prior treatment with Erbitux
Other cancers

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162110

Locations

United States, New York
Local Institution
New York, New York, United States
United States, Ohio
Local Institution
Cincinnati, Ohio, United States

Sponsors and Collaborators

Bristol-Myers Squibb

ImClone LLC

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CA225-063
Study First Received:	September 9, 2005
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00162110 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Cetuximab
Adenocarcinoma
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Cetuximab

Adenocarcinoma
Pharmacologic Actions
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 11, 2009