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

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ClinicalTrials.gov Identifier: NCT00162110
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : October 28, 2015
Sponsor:
Collaborator:
ImClone LLC
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Mucinous Gastrointestinal Adenocarcinoma Drug: cetuximab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Erbitux for Recurrent and Metastatic Mucinous Gastrointestinal Adenocarcinoma Involving the Peritoneal Surfaces
Study Start Date : November 2004
Primary Completion Date : January 2007
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Drug: cetuximab
mg, IV, 225 mg/m2, weekly, 4-52 weeks depending on response.
Other Name: Erbitux



Primary Outcome Measures :
  1. Evaluate the efficacy of Erbitux in the treatment of mucinous gastrointestinal adenocarcinoma involving the peritoneal surfaces based on clinical response rate.

Secondary Outcome Measures :
  1. 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162110


Locations
United States, New York
Local Institution
New York, New York, United States
United States, Ohio
Local Institution
Cincinnati, Ohio, United States
Sponsors and Collaborators
Eli Lilly and Company
ImClone LLC
Investigators
Study Director: 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) Eli Lilly and Company

Additional Information:
ClinicalTrials.gov Identifier: NCT00162110     History of Changes
Other Study ID Numbers: CA225-063
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Cetuximab
Antineoplastic Agents