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

Phase 2

Completed

• Conditions: Mucinous Gastrointestinal Adenocarcinoma
• Interventions: Drug: cetuximab

• 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

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-13
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-26
• Last Update Posted: 2015-10-28

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