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A Phase I Study of Cetuximab in Combination With Gefitinib in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00162318
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
The purpose of this study is to find a safe and effective dose of Erbitux and Iressa for subject with non small cell lung cancer.

Condition Intervention Phase
Non-Small-Cell Lung Carcinoma Drug: Cetuximab + Gefitinib Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Cetuximab in Combination With Gefitinib in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Safe and effective dose of combination of Erbitux and Iressa therapy.

Secondary Outcome Measures:
  • Response will be measured by radiographic measurement of disease every 4 weeks.

Estimated Enrollment: 30
Study Start Date: March 2005
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Cetuximab + Gefitinib
IV solution + tablet, IV + oral, ERB (100 mg/m2, 200 mg/m2 + 250 mg/m2 IV) +GEF 250 mg tablet, ERB weekly/ GEF once daily, Until disease progression.
Other Name: Erbitux

  Eligibility

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:

  • Subjects with advanced or metastatic non small cell lung cancer.
  • Subjects should have had at least one prior chemotherapy with a platinum based therapy.

Exclusion Criteria:

  • Subjects are excluded from this study if they do not have non small cell lung cancer that is advanced or metastatic or have not had at least one prior platinum based chemotherapy.
  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): NCT00162318


Locations
United States, Pennsylvania
Local Institution
Pittsburgh, Pennsylvania, 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: NCT00162318     History of Changes
Other Study ID Numbers: CA225-064
First Submitted: September 9, 2005
First Posted: September 13, 2005
Last Update Posted: October 28, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Cetuximab
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action