Ignite Creation Date:
2024-05-06 @ 12:40 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01636622
Status:
COMPLETED
Last Update Posted:
2020-06-18
First Post:
2012-07-06
Brief Title:
Study of Vemurafenib Carboplatin and Paclitaxel
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Study of the Combination of Vemurafenib With Carboplatin and Paclitaxel in Patients With Advanced Malignancy
Status:
COMPLETED
Status Verified Date:
2020-06
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 find the highest tolerable dose of vemurafenib that can be given in combination with carboplatin and paclitaxel patients with advanced cancer The safety of the study drug combination will also be studied
Vemurafenib is designed to block a protein called mutated BRAF that is only found in moles spots of the skin and certain types of cancer cells This drug may slow the growth of or kill these cells
Carboplatin is designed to slow the growth of cancer cells by stopping them from making new DNA the genetic material of cells
Paclitaxel is designed to slow the growth of cancer cells by stopping them from dividing into new cells
Vemurafenib is designed to block a protein called mutated BRAF that is only found in moles spots of the skin and certain types of cancer cells This drug may slow the growth of or kill these cells
Carboplatin is designed to slow the growth of cancer cells by stopping them from making new DNA the genetic material of cells
Paclitaxel is designed to slow the growth of cancer cells by stopping them from dividing into new cells
Detailed Description:
Study Groups
If you are found to be eligible and decide to take part you will be assigned to a study group based on when you join this study Up to 8 groups of 3-6 participants will be enrolled in this study
The dose of vemurafenib and the doses of carboplatin and paclitaxel you receive will depend on when you joined this study The first group of participants will receive the lowest dose level of vemurafenib carboplatin and paclitaxel Each new group will receive a higher dose level of the study drug combination than the group before it if no intolerable side effects were seen This will continue until the highest tolerable dose of the combination is found After that 10 additional participants will be enrolled
Study Drug Administration
Each study cycle is 3 weeks
You will start taking paclitaxel and carboplatin on Day 1 of Cycle 1 Paclitaxel will be given by vein over 3 hours and carboplatin will be given by vein over 30-60 minutes You may be given medications to reduce the risk of nausea and allergic reaction before these study drugs are given Both paclitaxel and carboplatin will be given every 3 weeks
You will start taking vemurafenib by mouth in the evening on Day 1 of Cycle 1 You will then take vemurafenib twice a day every day starting with Day 2 of Cycle 1
Study Visits
At every study visit you will be asked about any drugs you may be taking how you are feeling and if you have had any side effects
On Day 1 of Cycle 1
You will have a physical exam including measurement of your weight and vital signs if not done in the past 8 days
Your performance status will be recorded
Blood about 1 tablespoon will be drawn for routine tests if this was not done in the past 10 days
On Day 8 of Cycle 1
You will have a physical exam including measurement of your vital signs
Your performance status will be recorded
Blood about 1 tablespoon will be drawn for routine tests
On Day 1 of Cycles 2 and beyond
You will have a physical exam including measurement of your weight and vital signs
Your performance status will be recorded
Blood about 1 tablespoon will be drawn for routine tests
In Cycle 2 only you will have an ECG
After Cycle 4 if you are tolerating the study drug combination well and the study doctor agrees you may have your Day 1 visit every other cycle
Every 6 weeks every 2 cycles you will have a CT scan MRI scan bone scan andor x-ray to check the status of the disease
Length of Study Participation
You may continue taking the study drug combination for as long as the doctor thinks it is in your best interest
You will no longer be able to take the study drugs if the disease gets worse if you start having other health problems if intolerable side effects occur or if you are unable to follow study directions
Your participation on the study will be over when you have completed the End-of-Study Visit
End-of-Study Visit
Within 4 weeks after your last dose of study drugs
You will have a physical exam including measurement of your weight and vital signs
Your performance status will be recorded
Blood about 1 tablespoon will be drawn for routine tests
You will have an ECG
You will have a CT scan MRI scan bone scan andor x-ray to check the status of the disease
This is an investigational study Vemurafenib is FDA approved and commercially available to treat advanced melanoma with mutated BRAF Carboplatin and paclitaxel are FDA approved for certain types of cancers including lung and ovarian cancers Using the study drug combination to treat advanced cancer with a BRAF mutation is considered investigational
Up to 96 participants will be enrolled in this study All will take part at MD Anderson
If you are found to be eligible and decide to take part you will be assigned to a study group based on when you join this study Up to 8 groups of 3-6 participants will be enrolled in this study
The dose of vemurafenib and the doses of carboplatin and paclitaxel you receive will depend on when you joined this study The first group of participants will receive the lowest dose level of vemurafenib carboplatin and paclitaxel Each new group will receive a higher dose level of the study drug combination than the group before it if no intolerable side effects were seen This will continue until the highest tolerable dose of the combination is found After that 10 additional participants will be enrolled
Study Drug Administration
Each study cycle is 3 weeks
You will start taking paclitaxel and carboplatin on Day 1 of Cycle 1 Paclitaxel will be given by vein over 3 hours and carboplatin will be given by vein over 30-60 minutes You may be given medications to reduce the risk of nausea and allergic reaction before these study drugs are given Both paclitaxel and carboplatin will be given every 3 weeks
You will start taking vemurafenib by mouth in the evening on Day 1 of Cycle 1 You will then take vemurafenib twice a day every day starting with Day 2 of Cycle 1
Study Visits
At every study visit you will be asked about any drugs you may be taking how you are feeling and if you have had any side effects
On Day 1 of Cycle 1
You will have a physical exam including measurement of your weight and vital signs if not done in the past 8 days
Your performance status will be recorded
Blood about 1 tablespoon will be drawn for routine tests if this was not done in the past 10 days
On Day 8 of Cycle 1
You will have a physical exam including measurement of your vital signs
Your performance status will be recorded
Blood about 1 tablespoon will be drawn for routine tests
On Day 1 of Cycles 2 and beyond
You will have a physical exam including measurement of your weight and vital signs
Your performance status will be recorded
Blood about 1 tablespoon will be drawn for routine tests
In Cycle 2 only you will have an ECG
After Cycle 4 if you are tolerating the study drug combination well and the study doctor agrees you may have your Day 1 visit every other cycle
Every 6 weeks every 2 cycles you will have a CT scan MRI scan bone scan andor x-ray to check the status of the disease
Length of Study Participation
You may continue taking the study drug combination for as long as the doctor thinks it is in your best interest
You will no longer be able to take the study drugs if the disease gets worse if you start having other health problems if intolerable side effects occur or if you are unable to follow study directions
Your participation on the study will be over when you have completed the End-of-Study Visit
End-of-Study Visit
Within 4 weeks after your last dose of study drugs
You will have a physical exam including measurement of your weight and vital signs
Your performance status will be recorded
Blood about 1 tablespoon will be drawn for routine tests
You will have an ECG
You will have a CT scan MRI scan bone scan andor x-ray to check the status of the disease
This is an investigational study Vemurafenib is FDA approved and commercially available to treat advanced melanoma with mutated BRAF Carboplatin and paclitaxel are FDA approved for certain types of cancers including lung and ovarian cancers Using the study drug combination to treat advanced cancer with a BRAF mutation is considered investigational
Up to 96 participants will be enrolled in this study All will take part at MD 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-2012-01221 | REGISTRY | NCI CTRP | None |