Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250978
Status:
COMPLETED
Last Update Posted:
2008-04-30
First Post:
2005-11-07
Brief Title:
Ph IBevacizumab Chemotherapy in Pts wMalig Pleural Effusion Due to Adv NSCLC
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase I of Bevacizumab Plus Chemotherapy in Patients With Malignant Pleural Effusion Due to Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2008-04
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:
Your lung cancer has caused fluid to build up in the space around your lung This fluid is called a malignant pleural effusion This fluid takes up space in your chest and prevents your lung from fully filling with air As a result you may be experiencing shortness of breath cough or chest discomfort Your doctors have determined that you would feel better if a surgeon or pulmonary specialist removed this fluid immediately Your doctors are offering to admit you to the hospital and drain the fluid using a Pleur-XTM catheter
Once the Pleur-X catheter is in place your doctors would like to start your chemotherapy
Your doctors have decided to treat you with chemotherapy If the chemotherapy works to kill the cancer cells in your body the cancer will make less fluid and your doctors will be able to remove the Pleur-XTM catheter sooner
It is possible that adding a second drug to the chemotherapy called bevacizumab may make he fluid dry up even faster It is not known whether adding bevacizumab to chemotherapy for patients with a Pleur-XTM catheter in place is more helpful or potentially more harmful than using chemotherapy alone For this reason only patients enrolled in this research protocol can receive both chemotherapy and bevacizumab while they have a Pleur-XTM catheter in place
The purpose of this research study is to determine whether chemotherapy may be delivered safely with a Pleur-XTM catheter in place
Once the Pleur-X catheter is in place your doctors would like to start your chemotherapy
Your doctors have decided to treat you with chemotherapy If the chemotherapy works to kill the cancer cells in your body the cancer will make less fluid and your doctors will be able to remove the Pleur-XTM catheter sooner
It is possible that adding a second drug to the chemotherapy called bevacizumab may make he fluid dry up even faster It is not known whether adding bevacizumab to chemotherapy for patients with a Pleur-XTM catheter in place is more helpful or potentially more harmful than using chemotherapy alone For this reason only patients enrolled in this research protocol can receive both chemotherapy and bevacizumab while they have a Pleur-XTM catheter in place
The purpose of this research study is to determine whether chemotherapy may be delivered safely with a Pleur-XTM catheter in place
Detailed Description:
The study will be conducted in patients with advanced NSCLC stage IIIB-IV who have MPE requiring therapeutic drainage and are also eligible for treatment with chemotherapy plus bevacizumab as defined in protocol Section 60 All patients will undergo placement of a Pleur-XTM catheter as part of routine practice Eligible patients may enroll in the protocol prior to or within 10 days following placement of their Pleur-XTM catheter Upon enrollment patients will be given a logsheet on which to record the volume of pleural fluid drained from their catheter Only patients who in the opinion of the treating physician do not have a hemorrhagic pleural effusion grossly bloody or pleural fluid hemoglobin concentration 25 of blood hemoglobin concentration may remain on study In addition only patients who in the opinion of the treating physician have satisfactory placement of their Pleur-XTM catheter may remain on study
Approximately 15 patients will be enrolled with the goal to treat 10 patients with chemotherapy plus bevacizumab The additional enrollments will be necessary in that it is estimated that approximately 1 in 3 patients will be taken off study due to failure of Pleur-XTM catheter placement or discovery of hemorrhagic effusion
Patients who remain on study will begin chemotherapy All eligible patients will receive bevacizumab 15mgkg IV x 1 dose as a single agent Three weeks later chemotherapy will be initiated according to routine clinical practice along with continued use of bevacizumab Acceptable chemotherapy regimens for this protocol are detailed in Section 50 of the protocol Only the administration of bevacizumab will be governed by the protocol Section 110 Dose reductions of all other drugs will be made according to routine clinical practice Pleural fluid will be drained from the Pleur-XTM at least every other day qod and volume recorded by the patient in a log book Pleur-XTM catheters may be removed when pleural symphysis is achieved defined in Section 120 or at the discretion of the treating physician The schedule of follow-up visits may vary according to the chemotherapy regimen however all patients must be evaluated in the clinic at least every 3 weeks with a doctor visit to record drainage volume and status of their Pleur-XTM catheter
Approximately 15 patients will be enrolled with the goal to treat 10 patients with chemotherapy plus bevacizumab The additional enrollments will be necessary in that it is estimated that approximately 1 in 3 patients will be taken off study due to failure of Pleur-XTM catheter placement or discovery of hemorrhagic effusion
Patients who remain on study will begin chemotherapy All eligible patients will receive bevacizumab 15mgkg IV x 1 dose as a single agent Three weeks later chemotherapy will be initiated according to routine clinical practice along with continued use of bevacizumab Acceptable chemotherapy regimens for this protocol are detailed in Section 50 of the protocol Only the administration of bevacizumab will be governed by the protocol Section 110 Dose reductions of all other drugs will be made according to routine clinical practice Pleural fluid will be drained from the Pleur-XTM at least every other day qod and volume recorded by the patient in a log book Pleur-XTM catheters may be removed when pleural symphysis is achieved defined in Section 120 or at the discretion of the treating physician The schedule of follow-up visits may vary according to the chemotherapy regimen however all patients must be evaluated in the clinic at least every 3 weeks with a doctor visit to record drainage volume and status of their Pleur-XTM catheter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None