Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251498
Status:
COMPLETED
Last Update Posted:
2008-08-21
First Post:
2005-11-08
Brief Title:
Phase II Study of Cetuximab in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
Veeda Oncology
Organization:
Veeda Oncology
Study Overview
Official Title:
Phase II Study of Cetuximab in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to determine the efficacy response rate of cetuximab when administered in combination with docetaxel and carboplatin for treatment of patients with advanced non-small cell lung cancer
The secondary objectives of this study are
to determine the time to progression and overall survival for patients with advanced NSCLC who are treated with the combination docetaxel carboplatin and cetuximab
to determine the toxicity of the combination in patients with advanced NSCLC
Patients with stages IIIB pleural or pericardial effusion and IV NSCLC who have not received any prior chemotherapy will be eligible to participate in the trial Other eligibility criteria include ECOG PS 0-1 normal hepatic and renal function age 18 years Specific inclusion and exclusion criteria are detailed in Sections 42 and 43
The secondary objectives of this study are
to determine the time to progression and overall survival for patients with advanced NSCLC who are treated with the combination docetaxel carboplatin and cetuximab
to determine the toxicity of the combination in patients with advanced NSCLC
Patients with stages IIIB pleural or pericardial effusion and IV NSCLC who have not received any prior chemotherapy will be eligible to participate in the trial Other eligibility criteria include ECOG PS 0-1 normal hepatic and renal function age 18 years Specific inclusion and exclusion criteria are detailed in Sections 42 and 43
Detailed Description:
This is a phase II open label non-randomized study in patients with histologicallycytologically confirmed stage IIIB pleural or pericardial effusion or stage IV NSCLC who have not received prior chemotherapy The trial will evaluate the efficacy and safety profile of the combination of docetaxel carboplatin and cetuximab for patients with advanced NSCLC
Patients will receive a combination of docetaxel and carboplatin administered every 3 weeks plus cetuximab given weekly A maximum of four cycles of chemotherapy will be administered to patients Patients who demonstrate an ongoing response CRPRSD at the end of 4th cycle of chemotherapy may receive two more cycles of treatment Patients who continue to respond CRPRSD after six cycles of therapy may receive therapy with single agent cetuximab 250 mgm2week for up to 1 year or until disease progression or unacceptable toxicity whichever occurs first
Patients will be evaluated for response time to progression and overall survival In addition the safety profile of the combination will be assessed
Patients will receive a combination of docetaxel and carboplatin administered every 3 weeks plus cetuximab given weekly A maximum of four cycles of chemotherapy will be administered to patients Patients who demonstrate an ongoing response CRPRSD at the end of 4th cycle of chemotherapy may receive two more cycles of treatment Patients who continue to respond CRPRSD after six cycles of therapy may receive therapy with single agent cetuximab 250 mgm2week for up to 1 year or until disease progression or unacceptable toxicity whichever occurs first
Patients will be evaluated for response time to progression and overall survival In addition the safety profile of the combination will be assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None