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

Mucinous Gastrointestinal Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162110
• Other study ID #: CA225-063
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: October 26, 2015
• Start date: November 2004
• Est. completion date: January 2007

Study information

• Verified date: October 2015
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Mucinous Gastrointestinal Adenocarcinoma

Intervention

Drug:
• cetuximab
mg, IV, 225 mg/m2, weekly, 4-52 weeks depending on response.

Locations

Country	Name	City	State
United States	Local Institution	Cincinnati	Ohio
United States	Local Institution	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	ImClone LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the efficacy of Erbitux in the treatment of mucinous gastrointestinal adenocarcinoma involving the peritoneal surfaces based on clinical response rate.
Secondary	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.

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm