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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:
Collaborator:
ImClone LLC
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00162110
First received: September 9, 2005
Last updated: February 12, 2010
Last verified: June 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

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

Further study details as provided by Bristol-Myers Squibb:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Bristol-Myers Squibb
ImClone LLC
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00162110     History of Changes
Other Study ID Numbers: CA225-063
Study First Received: September 9, 2005
Last Updated: February 12, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Cystic, Mucinous, and Serous
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013