Phase II Trial of Cetuximab Plus Vinorelbine in Previously Untreated Patients > 70 With Advanced NSCLC
- 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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the overall response of cetuximab plus vinorelbine in patients 70 years or older with non-small lung cancer.
Pasi A Janne, MD, PhD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|