Back to resultsA Trial of Erbitux for Recurrent and Metastatic Mucinous Gastrointestinal Adenocarcinoma Involving the Peritoneal Surfaces
Primary Purpose
Mucinous Gastrointestinal Adenocarcinoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cetuximab
Sponsored by
About this trial
This is an interventional treatment trial for Mucinous Gastrointestinal Adenocarcinoma
Eligibility Criteria
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
Sites / Locations
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Evaluate the efficacy of Erbitux in the treatment of mucinous gastrointestinal adenocarcinoma involving the peritoneal surfaces based on clinical response rate.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00162110
First Posted
September 9, 2005
Last Updated
October 26, 2015
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00162110
Brief Title
A Trial of Erbitux for Recurrent and Metastatic Mucinous Gastrointestinal Adenocarcinoma Involving the Peritoneal Surfaces
Official Title
A Phase II Trial of Erbitux for Recurrent and Metastatic Mucinous Gastrointestinal Adenocarcinoma Involving the Peritoneal Surfaces
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucinous Gastrointestinal Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
mg, IV, 225 mg/m2, weekly, 4-52 weeks depending on response.
Primary Outcome Measure Information:
Title
Evaluate the efficacy of Erbitux in the treatment of mucinous gastrointestinal adenocarcinoma involving the peritoneal surfaces based on clinical response rate.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
New York
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Cincinnati
State/Province
Ohio
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Trial of Erbitux for Recurrent and Metastatic Mucinous Gastrointestinal Adenocarcinoma Involving the Peritoneal Surfaces
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