A Phase II Trial of Erbitux for Recurrent and Metastatic Mucinous Gastrointestinal Adenocarcinoma Involving the Peritoneal Surfaces
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Mucinous Gastrointestinal Adenocarcinoma
Both
Mucinous Gastrointestinal Adenocarcinoma
Trial Information
A Phase II Trial of Erbitux for Recurrent and Metastatic Mucinous Gastrointestinal Adenocarcinoma Involving the Peritoneal Surfaces
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Evaluate the efficacy of Erbitux in the treatment of mucinous gastrointestinal adenocarcinoma involving the peritoneal surfaces based on clinical response rate.
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA225-063
NCT ID:
NCT00162110
Start Date:
November 2004
Completion Date:
January 2007
Related Keywords:
- Mucinous Gastrointestinal Adenocarcinoma
- Adenocarcinoma
- Adenocarcinoma, Mucinous
Name | Location |
|---|---|
| Local Institution | Bronx, New York |
| Local Institution | Cincinnati, Ohio |
