A Trial of Erbitux for Recurrent and Metastatic Mucinous Gastrointestinal Adenocarcinoma Involving the Peritoneal Surfaces
This study has been completed.
Information provided by:
First received: September 9, 2005
Last updated: February 12, 2010
Last verified: June 2008
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Erbitux for Recurrent and Metastatic Mucinous Gastrointestinal Adenocarcinoma Involving the Peritoneal Surfaces|
Resource links provided by NLM:
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.
|Study Start Date:||November 2004|
|Study Completion Date:||January 2007|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
|Active Comparator: 1||
mg, IV, 225 mg/m2, weekly, 4-52 weeks depending on response.
Other Name: Erbitux
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162110
|United States, New York|
|New York, New York, United States|
|United States, Ohio|
|Cincinnati, Ohio, United States|
Sponsors and Collaborators
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|