Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00271505
Status:
COMPLETED
Last Update Posted:
2020-05-11
First Post:
2005-12-29
Brief Title:
AvastinDocetaxelCarboplatin in Non-Small Cell Lung Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Evaluation of Avastin in Combination With Docetaxel and Carboplatin as Chemotherapy in Patients With Metastatic Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2020-04
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:
The goal of this clinical research study is to evaluate the effectiveness of Avastin in combination with docetaxel and carboplatin in the treatment of lung cancer The safety of this combination will also be studied
Detailed Description:
Avastin is a humanized monoclonal antibody that binds to vascular endothelial growth factor VEGF VEGF plays an important role in the growth of both normal and abnormal blood vessels Avastin is designed to prevent or slow down the growth of cancer cells by blocking the effects of VEGF
Docetaxel and carboplatin are standard chemotherapy drugs that have been approved by the FDA for the treatment of NSCLC Docetaxel and carboplatin are designed to work by stopping the division of cancer cells
If you are found to be eligible you will begin receiving Avastin docetaxel and carboplatin Avastin carboplatin and docetaxel will be given by vein once every 3 weeks The first dose of Avastin will be given over 90 minutes The second dose of Avastin will be given over 60 minutes All other doses of Avastin will be given over 30 minutes Carboplatin and docetaxel will always be given over 30 minutes They will be given on the same day every 3 weeks 1 cycle You may receive up to 6 cycles of treatment You will receive standard premedication with dexamethasone to help decrease the risk of side effects Dexamethasone will be taken before you receive your docetaxel infusion
During the study you will have blood tests about 2 teaspoons every 3 weeks to look at your blood counts These samples will be used only for routine lab tests You will be seen by a physician every 3 weeks and given a physical exam Your blood pressure will be monitored and you will be asked about any side effects you are experiencing A performance status evaluation will also be done In addition you will have a urine test every 2 cycles of treatment
After 2 cycles of treatment 6 weeks you will have a chest x-ray and computerized tomography CT or magnetic resonance imaging MRI scan to evaluate the status of the disease These will be repeated every 2 cycles Your continued participation in this study depends on how your cancer responds to the study drugs Your doctor may decide to take you off this study if you experience significant side effects or your medical condition worsens You may continue receiving bevacizumab for as long as your cancer responds to study treatment
You will be followed-up on by phone or at routine clinic visits for at least 12 months to monitor your condition and disease status
This is an investigational study Avastin has been approved by the FDA for the treatment of colorectal cancer Docetaxel and carboplatin are FDA approved and commercially available The use of these drugs together in this study is experimental A total of 50 patients will take part in this study All participants will be enrolled at M D Anderson
Docetaxel and carboplatin are standard chemotherapy drugs that have been approved by the FDA for the treatment of NSCLC Docetaxel and carboplatin are designed to work by stopping the division of cancer cells
If you are found to be eligible you will begin receiving Avastin docetaxel and carboplatin Avastin carboplatin and docetaxel will be given by vein once every 3 weeks The first dose of Avastin will be given over 90 minutes The second dose of Avastin will be given over 60 minutes All other doses of Avastin will be given over 30 minutes Carboplatin and docetaxel will always be given over 30 minutes They will be given on the same day every 3 weeks 1 cycle You may receive up to 6 cycles of treatment You will receive standard premedication with dexamethasone to help decrease the risk of side effects Dexamethasone will be taken before you receive your docetaxel infusion
During the study you will have blood tests about 2 teaspoons every 3 weeks to look at your blood counts These samples will be used only for routine lab tests You will be seen by a physician every 3 weeks and given a physical exam Your blood pressure will be monitored and you will be asked about any side effects you are experiencing A performance status evaluation will also be done In addition you will have a urine test every 2 cycles of treatment
After 2 cycles of treatment 6 weeks you will have a chest x-ray and computerized tomography CT or magnetic resonance imaging MRI scan to evaluate the status of the disease These will be repeated every 2 cycles Your continued participation in this study depends on how your cancer responds to the study drugs Your doctor may decide to take you off this study if you experience significant side effects or your medical condition worsens You may continue receiving bevacizumab for as long as your cancer responds to study treatment
You will be followed-up on by phone or at routine clinic visits for at least 12 months to monitor your condition and disease status
This is an investigational study Avastin has been approved by the FDA for the treatment of colorectal cancer Docetaxel and carboplatin are FDA approved and commercially available The use of these drugs together in this study is experimental A total of 50 patients will take part in this study All participants will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-01621 | REGISTRY | NCI CTRP | None |