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

This study has been completed.
Sponsor:
Collaborator:
ImClone LLC
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00162110
First received: September 9, 2005
Last updated: February 12, 2010
Last verified: June 2008

September 9, 2005
February 12, 2010
November 2004
January 2007   (final data collection date for primary outcome measure)
Evaluate the efficacy of Erbitux in the treatment of mucinous gastrointestinal adenocarcinoma involving the peritoneal surfaces based on clinical response rate.
Same as current
Complete list of historical versions of study NCT00162110 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
A Trial of Erbitux for Recurrent and Metastatic Mucinous Gastrointestinal Adenocarcinoma Involving the Peritoneal Surfaces
A Phase II Trial of Erbitux for Recurrent and Metastatic Mucinous Gastrointestinal Adenocarcinoma Involving the Peritoneal Surfaces

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mucinous Gastrointestinal Adenocarcinoma
Drug: cetuximab
mg, IV, 225 mg/m2, weekly, 4-52 weeks depending on response.
Other Name: Erbitux
Active Comparator: 1
Intervention: Drug: cetuximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2007
January 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00162110
CA225-063
Not Provided
Not Provided
Bristol-Myers Squibb
ImClone LLC
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2008

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