ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00162318
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:
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 or disease Intervention/treatment Phase
Non-Small-Cell Lung Carcinoma Drug: Cetuximab + Gefitinib Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
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
Study Start Date : March 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
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



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

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


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:

  • 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.

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

Additional Information:
ClinicalTrials.gov Identifier: NCT00162318     History of Changes
Other Study ID Numbers: CA225-064
First Posted: September 13, 2005    Key Record Dates
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