An Open Label Phase I/II Study of Cabazitaxel With or Without Carboplatin in Patients With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Therapy
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to 1 of 2
treatment groups (depending on when you enroll).
- If you are in Group 1, you will receive cabazitaxel plus prednisone.
- If you are in Group 2, you will receive cabazitaxel in combination with carboplatin
plus prednisone.
The first 9-18 participants will be assigned to Group 2 and enrolled in the Phase I portion
of the study. If you are enrolled in the Phase I portion, the combination dose of
carboplatin and cabazitaxel you receive will depend on when you joined this study. The
first group of participants will receive the lowest combination dose level. Each new group
will receive a higher combination dose than the group before it, if no intolerable side
effects were seen. This will continue until the highest tolerable combination dose of
carboplatin and cabazitaxel is found.
Once the highest tolerable combination dose is found, all patients enrolled after that will
be randomly assigned (as in the flip of a coin) to a study group in Phase 2. You will have
an equal chance of being assigned to each group.
Your study doctor will tell you which phase and group you are in, and the dose level of the
drugs you will receive.
All participants will receive the same dose level of prednisone.
Study Drug Administration:
You will receive cabazitaxel by vein over about 60 minutes on Day 1 of each 21-day study
cycle. If you receive carboplatin, you will also receive it by vein, after your cabazitaxel
dose, over about 60 minutes on Day 1 of each cycle. You will take prednisone tablets by
mouth twice a day (morning and evening), on Day 1 of each cycle.
About 30 minutes before you receive the study drug(s), you will be given drugs (for example,
the drug filgrastim) to help prevent side effects. Your doctor will describe these drugs to
you in more detail, including how they are given and any side effects you may expect.
Study Visits:
On Day 1 of each cycle:
- Your complete medical history will be recorded.
- You will have a physical exam.
- Your weight and vital signs will be recorded.
- You will be asked about any side effects you may have experienced and about any drugs
you may be taking.
- Blood (about 3 teaspoons) and urine will be collected for routine tests. These tests
can be done up to 7 days before this visit.
On 1 day between Days 7 and 10 of Cycle 1, blood (about 3 teaspoons) will be drawn for
routine tests. If the doctor thinks it is needed during any other cycle, this blood draw
will be repeated.
After every 2 cycles, you will have a bone scan and either a CT scan or MRI scan of your
chest, abdomen, and pelvis to check the status of the disease.
Length of Treatment:
You may receive the study drug(s) for up to 10 total cycles. You will be taken off study if
intolerable side effects occur, if you are unable to follow study directions, or if the
disease gets worse.
Your participation on the study will be over once you have completed the end-of-dosing and
follow-up visits.
End-of-Dosing Visit:
After you are no longer receiving the study drug(s), you will have an end-of-dosing visit.
The following tests and procedures will be performed:
- Your complete medical history will be recorded.
- You will have a physical exam.
- Your weight and vital signs will be recorded.
- You will be asked about any side effects you may have experienced and about any drugs
you may be taking.
- Blood (about 3 tablespoons) and urine will be collected for routine tests.
- You will have either a CT or MRI scan of your chest, abdomen, and pelvis to check the
status of the disease.
- If your doctor thinks it is needed, you will have a bone scan to check the status of
the disease.
Long-term Follow-up:
After the end-of-dosing visit, the study staff will call you or review your medical record.
If contacted by phone, you will be asked about how you are feeling and any side effects you
may have had. Each follow-up call will take about 5 minutes. Follow-up will take place
every 6 months after you stop taking the study drugs.
This is an investigational study. Cabazitaxel, carboplatin, and prednisone are FDA approved
and commercially available. The use of these drugs in combination for the treatment of
prostate cancer is investigational.
Up to 178 patients will be enrolled in this study. Up to 128 will be enrolled at MD
Anderson.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Progression Free Survival (PFS)
Evaluation of measurable disease response will follow the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines. Complete Response: The disappearance of all target lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease: At least a 20% increase in the sum of the longest diameter of target lesions. Stable Disease: Insufficient shrinkage to qualify for partial response, or insufficient increase to qualify for progressive disease.
42 days
Yes
Paul Corn, MD,PHD
Principal Investigator
UT MD Anderson Cancer Center
United States: Institutional Review Board
2011-0727
NCT01505868
July 2012
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |