Phase I Study of Weekly LOC-paclitaxel Injection
The Study Drug:
Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.
LOC-paclitaxel is a redesigned version of paclitaxel. Fatty acid is added to paclitaxel,
which may help paclitaxel to stay in the tumor for longer at higher concentrations. This is
the first study using LOC-paclitaxel in humans.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose
level of LOC-paclitaxel based on when you joined this study. Up to 9 dose levels of
LOC-paclitaxel will be tested. Three (3) to 6 participants will be enrolled at each dose
level. The first group of participants will receive the lowest dose level. Each new group
will receive a higher dose than the group before it, if no intolerable side effects were
seen. This will continue until the highest tolerable dose of LOC-paclitaxel is found.
Once the highest tolerable dose of LOC-paclitaxel is found, 12 participants will receive the
study drug at that dose level.
Study Drug Administration:
Each study cycle is 6 weeks.
You will receive LOC-paclitaxel by vein over 1 hour on Days 1, 8, 15, 22, and 29 of each
cycle.
If you experience side effects, your dose of study drug may be lowered.
Study Visits:
On Day 1 of each cycle:
- 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 and to test for tumor
markers.
- If you have melanoma of the head and neck, you will have a CT scan of the neck.
- If you have skin lesions, photographs will be taken of the lesions. Your private areas
will be covered (as much as possible), and a picture of your face will not be taken
unless there are lesions on your face. You will not be able to be identified by any
pictures that may be taken of your lesions.
Once a week:
- Blood (about 1 teaspoon) will be drawn to check your blood cell counts.
- Urine will be collected for routine tests.
- You will be asked if you experienced any side effects.
Every 6 weeks, you will have x-rays and CT scans to check the status of the disease as per
standard of care. If you have had a response to treatment (the disease has disappeared or
the tumors have gotten smaller), the x-rays and CT scans will be repeated again in 4 weeks.
After that, they will be repeated every 6 weeks.
If you experience low blood counts while you are on study, and the doctor thinks it is
severe, you will have a bone marrow biopsy to check for the cause of the low blood counts.To
collect a bone marrow biopsy, an area of the hip is numbed with anesthetic, and a small
amount of bone marrow and bone is withdrawn through a large needle.
If the doctor thinks it is needed, you will have ECGs and extra blood (about 1 teaspoon)
will be drawn.
Any of the procedures listed in this consent form may be performed more frequently, if your
doctor thinks they are needed.
Pharmacokinetic (PK) Testing:
Extra blood will also be drawn for PK testing. PK testing measures the amount of study drug
in the body at different time points. Blood (about 2 teaspoons each time) will be drawn at
the following times:
- On Day 1 of Cycle 1, blood will be drawn before the dose of LOC-paclitaxel, at the end
of the dose, and then 5 more times over the next 11 hours after the dose.
- On Days 2-7 of Cycle 1, blood will be drawn 1 time each day.
- On Days 8, 15, and 22 of Cycle 1, blood will be drawn 1 time each day.
- On Day 29 of Cycle 1, blood will be drawn before the dose, at the end of the dose, and
then 5 more times over the next 11 hours after the dose.
- On Days 30-35 of Cycle 1, blood will be drawn 1 time each day.
Length of Study:
You will be on study for as long as you are benefiting. You will be taken off the study if
you experience intolerable side effects or the disease gets worse.
End-of-Study Visit:
After you are off study, you will have an end-of-study visit. At this visit, the following
tests and procedures will be performed:
- 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 and to measure tumor
markers.
- You will have CT scans to check the status of the disease.
- If you are having low blood counts, you will have a bone marrow biopsy to check for
side effects.
- If you have skin lesions, photographs will be taken of the lesions.
After you go off study, extra tests may be needed for your safety. This may include routine
blood tests (about 1 tablespoon) and will be continued until you have recovered from any
side effects, which may be 3-4 weeks.
This is an investigational study. LOC-paclitaxel is not FDA approved or commercially
available. LOC-paclitaxel is currently being used for research purposes only.
Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
6 week cycles
Yes
Agop Y. Bedikian, MD, BS
Study Chair
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2009-0432
NCT01039844
December 2009
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |