Cetuximab and Vinorelbine in Elderly Subjects With Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is it to determine how well patients with non-small cell lung cancer respond to cetuximab plus vinorelbine. We would also like to determine the safety of cetuximab plus vinorelbine in people 70 years of age or older with advanced non-small cell lung cancer.

Detailed Description
-----------------
Each cycle of study treatment is 21 days long. Cetuximab will be administered weekly intravenously on days 1, 8 and 15 of the 21-day cycle. Vinorelbine will be administered intravenously on days 1 and 8 of the 21-day cycle. On the days when the patient receives both cetuximab and vinorelbine, cetuximab will be given first. For the first cycle only, the first infusion of cetuximab will be in a larger dose and over a two-hour period of time. Beginning with the second treatment of cetuximab, the patient will receive a smaller dose over a one-hour period of time. For the first treatment of cetuximab, the patient will have their blood pressure, temperature, breathing rate and heart rate (vital signs) taken at the following time points: before the infusion, 1/2 hour into the infusion, at the end of infusion, and one hour after the infusion. For each subsequent cetuximab treatment, vital signs will be taken before each infusion and one hour after the end of infusion. The patient will be required to remain in the infusion room for one hour after the end of each cetuximab treatment for observation. CT scan(s), MRI(s), and/or x-rays(s) of the site(s) of cancer will be done every six weeks (every two cycles) while the patient is on the study to assess the extent of the cancer and the response to treatment. The duration of active participation in this study will depend on how the patients non-small cell lung cancer responds to treatment and how well they tolerate the treatment. The patient may receive up to six cycles of treatment with vinorelbine and cetuximab. After these six cycles the patient may continue on cetuximab alone as long as they are tolerating the drug and the cancer doesn't progress.

Official Title
-----------------
Phase II Trial of Cetuximab Plus Vinorelbine in Previously Untreated Patients > 70 With Advanced NSCLC

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Cetuximab
* Drug: Vinorelbine (Navelbine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 70 years of age or greater Stage IV or IIIB Non-small cell lung cancer Must at least be able to walk and capable of taking care of yourself although unable to carry out work activities 3 or more weeks since completing prior radiotherapy 3 or more weeks since prior major surgery Blood tests that show your kidneys, liver and bone marrow to be working adequately Life expectancy of 8 weeks or more Exclusion Criteria: Prior anticancer therapy within the past 3 years, including chemotherapy Other currently active cancer Uncontrolled Central Nervous System (CNS) problems Pre-existing disease or abnormality of the nervous system Hepatitis or Known HIV Active uncontrolled infection Incomplete healing from previous major surgery Significant history of uncontrolled cardiac disease such as high blood pressure, recent heart attack (within past 6 months), congestive heart failure, etc. Prior therapy which targets the ErbB pathway Prior severe infusion reaction to an antibody Chemotherapy or other investigational agent not indicated in the study protocol occuring at the same time as this study treatment A medical condition that could make it unsafe for you to participate in this study

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cetuximab|nan|
|Drug: Vinorelbine (Navelbine)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the overall response of cetuximab plus vinorelbine in patients 70 years or older with non-small lung cancer. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety of cetuximab plus vinorelbine in patients 70 years or older |  |  | 
| to determine the time to progression and survival rates of patients treated with cetuximab plus vinorelbine. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-small cell lung cancer, Cetuximab, Vinorelbine, Navelbine, Previously untreated lung cancer