Trials / Completed
CompletedNCT00103207
Cetuximab in Treating Patients With Recurrent or Stage IIIB or Stage IV Lung Cancer
Phase II Study of C225 (Cetuximab) for the Treatment of Patients With Advanced Bronchioalveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Eastern Cooperative Oncology Group · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | cetuximab |
Timeline
- Start date
- 2005-10-13
- Primary completion
- 2010-04-01
- Completion
- 2012-08-01
- First posted
- 2005-02-08
- Last updated
- 2023-06-28
- Results posted
- 2013-01-04
Locations
157 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00103207. Inclusion in this directory is not an endorsement.