Cetuximab and Vinorelbine in Elderly Subjects With Lung Cancer

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00165334

Collaborator

Massachusetts General Hospital (Other), Brigham and Women's Hospital (Other), Beth Israel Deaconess Medical Center (Other), Bristol-Myers Squibb (Industry)

Enrollment

Locations

Duration (Months)

17.7

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Drug: Cetuximab Drug: Vinorelbine (Navelbine)	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2005

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Outcome Measures

Primary Outcome Measures

To determine the overall response of cetuximab plus vinorelbine in patients 70 years or older with non-small lung cancer. []

Secondary Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02115
3	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115