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:
Collaborator:
ImClone LLC
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00162318
First received: September 9, 2005
Last updated: April 7, 2011
Last verified: July 2008

September 9, 2005
April 7, 2011
March 2005
April 2006   (final data collection date for primary outcome measure)
Safe and effective dose of combination of Erbitux and Iressa therapy.
Same as current
Complete list of historical versions of study NCT00162318 on ClinicalTrials.gov Archive Site
Response will be measured by radiographic measurement of disease every 4 weeks.
Same as current
Not Provided
Not Provided
 
A Phase I Study of Cetuximab in Combination With Gefitinib in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
A Phase I Study of Cetuximab in Combination With Gefitinib in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small-Cell Lung Carcinoma
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
Experimental: A
Intervention: Drug: Cetuximab + Gefitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2006
April 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00162318
CA225-064
Not Provided
Not Provided
Bristol-Myers Squibb
ImClone LLC
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP