Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411593
Status:
WITHDRAWN
Last Update Posted:
2012-02-08
First Post:
2006-12-12
Brief Title:
Phase I-II for Patients With Recurrent or Refractory Non-small Cell Lung Cancer NSCLC
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I-II Study of Avastin Bortezomib for Patients With Recurrent or Refractory Non-Squamous NSCLC
Status:
WITHDRAWN
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of Patient Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective
The primary objective of this phase I-II study is to evaluate
Phase I Assess the maximum tolerated dose MTD of bortezomib in a weekly schedule with bevacizumab given every 3 weeks
Phase II Using the MTD established in phase I assess efficacy of the combination as indicated by progression-free survival
Secondary Objectives
The secondary objectives of this study are to evaluate
Response rates and duration of response
1 year survival
Overall survival
Qualitative and quantitative toxicity
Circulating endothelial cells CECs prior to treatment prior to cycle 2 andor at the time of progression
The primary objective of this phase I-II study is to evaluate
Phase I Assess the maximum tolerated dose MTD of bortezomib in a weekly schedule with bevacizumab given every 3 weeks
Phase II Using the MTD established in phase I assess efficacy of the combination as indicated by progression-free survival
Secondary Objectives
The secondary objectives of this study are to evaluate
Response rates and duration of response
1 year survival
Overall survival
Qualitative and quantitative toxicity
Circulating endothelial cells CECs prior to treatment prior to cycle 2 andor at the time of progression
Detailed Description:
Bortezomib is designed to enter cells and interfere with a substance found inside cells that is responsible for allowing cells to divide
Avastin is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels
If you are found to be eligible to take part in this study depending on when you enroll you will be assigned to one of up to 4 treatment groups There will be 3 participants in each of the first few groups and an additional 30 participants in the last group The first few 2 or 3 groups are part of the first phase of the study and the last group 3rd or 4th is part of the second phase All participants will receive the same dose level of Avastin The amount of bortezomib you receive will depend on when you enroll in the study The exact dose of bortezomib that you receive will be based on your height and weight In the first phase of the study groups of participants will be assigned to one of 2 bortezomib dose levels The first group will receive the highest dose The next groups will receive either that same dose level or if intolerable side effects occurred a lower dose level For the second part of the study the last group will receive the highest dose level that did not cause intolerable side effects in the other groups
A cycle of treatment is 3 weeks 21 days Bortezomib will be given once a week for the first 2 weeks of each cycle Avastin will be given every 3 weeks On Day 1 of each cycle you will receive both bortezomib and Avastin
Bortezomib will be injected through a needle in your vein Each injection will last about 3-5 seconds After receiving each dose of bortezomib the clinic staff will check how well you are tolerating the drug During that time you will be asked about any side effects you may be experiencing Your doctor may decrease or pause the dose of bortezomib if you experience certain side effects
Avastin will be given as an infusion through a needle in your vein over 90 minutes If you tolerate the 90-minute infusion well the second infusion will be given over 60 minutes If you tolerate the 60-minute infusion well all following infusions will be given over 30 minutes If you do not tolerate the shorter infusion time future infusion times will be increased until a tolerable level is reached
Every 3 weeks you will have a physical exam including measurement of vital signs and weight Blood about 2 teaspoons will be drawn for routine tests You will have a performance status evaluation On Day 8 of each cycle of treatment blood about 2 teaspoons will be drawn for routine tests The level of protein in your urine will be monitored at least every 6 weeks
You may continue receiving study treatment for as long as the cancer responds to the treatment or for up to 1 year Your doctor may decide to take you off this study if you experience intolerable side effects or your health gets worse
After you have stopped taking the study treatment you will have a physical exam including measurement of vital signs Blood about 2 teaspoons will be drawn for routine tests You will have a performance status evaluation chest x-ray and a CT or MRI scan On an indefinite basis the study nurse will contact you by telephone from time to time to see how you are doing
This is an investigational study Bortezomib has been FDA approved and it is registered in Europe for the treatment of multiple myeloma patients who have received at least one prior therapy Avastin has been FDA approved for the treatment of metastatic colorectal cancer and non-small cell lung cancer However bortezomib and Avastin are not FDA-approved for this type of cancer and they have been authorized for use together in research only Up to 42 patients will take part in this study All will be enrolled at M D Anderson
Avastin is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels
If you are found to be eligible to take part in this study depending on when you enroll you will be assigned to one of up to 4 treatment groups There will be 3 participants in each of the first few groups and an additional 30 participants in the last group The first few 2 or 3 groups are part of the first phase of the study and the last group 3rd or 4th is part of the second phase All participants will receive the same dose level of Avastin The amount of bortezomib you receive will depend on when you enroll in the study The exact dose of bortezomib that you receive will be based on your height and weight In the first phase of the study groups of participants will be assigned to one of 2 bortezomib dose levels The first group will receive the highest dose The next groups will receive either that same dose level or if intolerable side effects occurred a lower dose level For the second part of the study the last group will receive the highest dose level that did not cause intolerable side effects in the other groups
A cycle of treatment is 3 weeks 21 days Bortezomib will be given once a week for the first 2 weeks of each cycle Avastin will be given every 3 weeks On Day 1 of each cycle you will receive both bortezomib and Avastin
Bortezomib will be injected through a needle in your vein Each injection will last about 3-5 seconds After receiving each dose of bortezomib the clinic staff will check how well you are tolerating the drug During that time you will be asked about any side effects you may be experiencing Your doctor may decrease or pause the dose of bortezomib if you experience certain side effects
Avastin will be given as an infusion through a needle in your vein over 90 minutes If you tolerate the 90-minute infusion well the second infusion will be given over 60 minutes If you tolerate the 60-minute infusion well all following infusions will be given over 30 minutes If you do not tolerate the shorter infusion time future infusion times will be increased until a tolerable level is reached
Every 3 weeks you will have a physical exam including measurement of vital signs and weight Blood about 2 teaspoons will be drawn for routine tests You will have a performance status evaluation On Day 8 of each cycle of treatment blood about 2 teaspoons will be drawn for routine tests The level of protein in your urine will be monitored at least every 6 weeks
You may continue receiving study treatment for as long as the cancer responds to the treatment or for up to 1 year Your doctor may decide to take you off this study if you experience intolerable side effects or your health gets worse
After you have stopped taking the study treatment you will have a physical exam including measurement of vital signs Blood about 2 teaspoons will be drawn for routine tests You will have a performance status evaluation chest x-ray and a CT or MRI scan On an indefinite basis the study nurse will contact you by telephone from time to time to see how you are doing
This is an investigational study Bortezomib has been FDA approved and it is registered in Europe for the treatment of multiple myeloma patients who have received at least one prior therapy Avastin has been FDA approved for the treatment of metastatic colorectal cancer and non-small cell lung cancer However bortezomib and Avastin are not FDA-approved for this type of cancer and they have been authorized for use together in research only Up to 42 patients will take part in this study All will be enrolled at M D Anderson
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