Cetuximab and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

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. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with radiation therapy works in treating patients with stage III non-small cell lung cancer.

Detailed Description
-----------------
OBJECTIVES: Primary * Determine the 11 month survival rate in older and/or poor performance status patients with stage IIIA or stage IIIB non-small cell lung cancer treated with cetuximab and radiotherapy. Secondary Determine the tumor response rate, overall survival, and time to disease progression in patients treated with this regimen. Determine the toxicity of this regimen in these patients. Determine whether fear of death is less severe in the oldest of patients treated with this regimen. Determine whether fear of death predicts survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, and 43. Beginning on day 8, patients receive concurrent radiotherapy once daily on days 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed within 1 week, at 1 and 4 months, and then every 3 months for up to 3 years. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 20 months

Official Title
-----------------
Cetuximab (C225) and Radiation in Elderly and /or Poor Performance Status Patients With Locally Advanced Non-Small Cell Lung Cancer: A Phase II Study to Evaluate Survival and Toxicity

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Biological: cetuximab
* Radiation: radiation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Stage IIIA or IIIB disease Must be a candidate for curative radiotherapy Not a candidate for other concurrent chemotherapy and radiotherapy No surgical treatment available No pleural effusion suspected or proven to be malignant No stage IV disease by bone scan or positron emission tomography scan, CT scan or MRI of the brain, and CT scan of the chest within the past 30 days PATIENT CHARACTERISTICS: Age * 18 and over Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 (age ≥ 65 years) ECOG 2 (age 18 to 64 years) Life expectancy * At least 12 weeks Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL Hepatic Bilirubin ≤ 2 times upper limit of normal (ULN) AST ≤ 3 times ULN Renal Creatinine ≤ 1.5 times ULN Pulmonary FEV_1 ≥ 1 L No idiopathic pulmonary fibrosis Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Magnesium normal No uncontrolled infection No other severe underlying disease that would preclude study entry No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma No major psychiatric illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy See Disease Characteristics No prior chemotherapy for NSCLC Endocrine therapy * Not specified Radiotherapy No prior therapeutic radiotherapy to the chest No concurrent intensity modulated radiotherapy Other * No prior epidermal growth factor receptor inhibitors

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cetuximab/Radiation<br>Cetuximab (C225) and Radiation | Biological: cetuximab<br> <br> Radiation: radiation therapy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 11-month Survival Rate | Eleven-month survival was chosen as the survival endpoint in this trial because it represents an improvement over the median survival that is observed with radiation alone. 11-month survival will be considered synonymous with success, unless specified otherwise. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. All evaluable patients will be followed from the time of protocol enrollment until death or a minimum of 11 months. | From baseline to 11 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Time | Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. | From baseline to up to 3 years | 
| Time to Disease Progression | Time to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. | From Baseline to up to 3 years | 
| Tumor Response (Complete and Partial) | A confirmed tumor response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 3 months apart. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. | Baseline, 1 month and 4 months after completion of treatment and then every 3 months until Progressive Disease (PD) or up to a maximum of 3 years from registration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer