Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103207
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2005-02-07
Brief Title:
Cetuximab in Treating Patients With Recurrent or Stage IIIB or Stage IV Lung Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Study of C225 Cetuximab for the Treatment of Patients With Advanced Bronchioalveolar Carcinoma BAC or Adenocarcinoma With BAC Features
Status:
COMPLETED
Status Verified Date:
2023-06
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:
RATIONALE Monoclonal antibodies such as cetuximab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them
PURPOSE This phase II trial is studying how well cetuximab works in treating patients with recurrent or stage IIIB or stage IV lung cancer
PURPOSE This phase II trial is studying how well cetuximab works in treating patients with recurrent or stage IIIB or stage IV lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the objective response rate in patients with recurrent or stage IIIB or IV bronchoalveolar carcinoma BAC or adenocarcinoma of the lung with BAC features treated with cetuximab
Secondary
Determine the overall survival and time to progression in patients treated with this drug
Determine the toxic effects of this drug in these patients
Correlate expression of total and phosphorylated epidermal growth factor receptor EGFR total and phosphorylated AKT3 and total and phosphorylated MAPKinase with response in patients treated with this drug
Determine whether the presence of polymorphisms or mutations in the EGFR gene influences response in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive cetuximab IV over 1-2 hours once on days 1 8 15 and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
ACTUAL ACCRUAL A total of 72 patients were accrued for this study
Primary
Determine the objective response rate in patients with recurrent or stage IIIB or IV bronchoalveolar carcinoma BAC or adenocarcinoma of the lung with BAC features treated with cetuximab
Secondary
Determine the overall survival and time to progression in patients treated with this drug
Determine the toxic effects of this drug in these patients
Correlate expression of total and phosphorylated epidermal growth factor receptor EGFR total and phosphorylated AKT3 and total and phosphorylated MAPKinase with response in patients treated with this drug
Determine whether the presence of polymorphisms or mutations in the EGFR gene influences response in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive cetuximab IV over 1-2 hours once on days 1 8 15 and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
ACTUAL ACCRUAL A total of 72 patients were accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA021115 | NIH | None | None |
| E1504 | OTHER | Eastern Cooperative Oncology Group ECOG | httpsreporternihgovquickSearchU10CA021115 |