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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00162110
First Posted: September 13, 2005
Last Update Posted: October 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ImClone LLC
Information provided by:
Eli Lilly and Company
  Purpose
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 Intervention Phase
Mucinous Gastrointestinal Adenocarcinoma Drug: cetuximab Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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.

Estimated Enrollment: 40
Study Start Date: November 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: cetuximab
mg, IV, 225 mg/m2, weekly, 4-52 weeks depending on response.
Other Name: Erbitux

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00162110     History of Changes
Other Study ID Numbers: CA225-063
First Submitted: September 9, 2005
First Posted: September 13, 2005
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