A Trial of Erbitux for Recurrent and Metastatic Mucinous Gastrointestinal Adenocarcinoma Involving the Peritoneal Surfaces
- Registration Number
- NCT00162110
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 cetuximab -
- Primary Outcome Measures
Name Time Method Evaluate the efficacy of Erbitux in the treatment of mucinous gastrointestinal adenocarcinoma involving the peritoneal surfaces based on clinical response rate.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Local Institution
🇺🇸Cincinnati, Ohio, United States