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.
Information provided by:
First received: September 9, 2005
Last updated: April 7, 2011
Last verified: July 2008
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.
|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 I Study of Cetuximab in Combination With Gefitinib in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
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.
|Study Start Date:||March 2005|
|Study Completion Date:||April 2006|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162318
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States|
Sponsors and Collaborators
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|