Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:07 AM
Study NCT ID:
NCT00165334
Status:
COMPLETED
Last Update Posted:
2009-07-22
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cetuximab and Vinorelbine in Elderly Subjects With Lung Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
Phase II Trial of Cetuximab Plus Vinorelbine in Previously Untreated Patients > 70 With Advanced NSCLC
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: