Phase I Study of the Combination of Vemurafenib With Carboplatin and Paclitaxel in Patients With Advanced Malignancy
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, and/or 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, and/or 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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
Maximum tolerated dose (MTD) defined as highest dose studied in which the incidence of the dose limiting toxicity (DLT) is < 33%. If at any time more than or equal to one third of participants at a dose level experience DLT, that dose is considered to be above the MTD.
6 weeks
Yes
Gerald Falchook, MD,MS
Principal Investigator
UT MD Anderson Cancer Center
United States: Institutional Review Board
2012-0394
NCT01636622
July 2012
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |