Phase II Study of C225 (Cetuximab) for the Treatment of Patients With Advanced Bronchioalveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 72
- Locations
- 314
- Primary Endpoint
- Objective Response Rate (Proportion of Patients With Objective Response)
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Objective Response Rate (Proportion of Patients With Objective Response)
Time Frame: Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years
Response was evaluated using RECIST 1.0 criteria. Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= \>=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.
Secondary Outcomes
- Overall Survival(Every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years)
- Time to Progression(Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years)
- Overall Survival by Smoking Status(Overall survival assessed every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline)
- Time to Progression by Smoking Status(Progression assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline)