A Phase II Trial of Pazopanib in Von Hippel-Lindau Syndrome
Study Groups and Study Drug Administration:
If you are found to be eligible to take part in this study, you will take pazopanib by mouth
1 time every day, at about the same time each day, at least 1 hour before or 2 hours after a
meal.
If you have any side effects from the drug, tell the study doctor right away. The study
doctor may then lower the dose or keep the dose level the same.
Each study cycle is 4 weeks.
Study Visits:
On Day 1 of Cycle 1:
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your vital signs and weight.
- You will be asked about any drugs or treatments you may be receiving.
- Your performance status will be recorded.
Every 2 weeks (for the first 8 weeks) and then once every cycle, blood (about 3 teaspoons)
will be drawn for routine tests.
Every 12 weeks (+/-7 days):
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your vital signs and weight.
- Your performance status will be recorded.
- You will be asked about any drugs or treatments you may be receiving and any side
effects that you have had.
At the end of Cycles 3 and 6 and then every 12 weeks:
- You will have CT scans and MRI scans to check the status of the disease.
- If the doctor thinks it is needed, you will have an eye exam.
Length of Study:
You may receive treatment on this study for up to 24 weeks (6 cycles). If your doctor thinks
you are benefitting, you may continue on study for an extra 18 cycles. You will no longer
be able to take the study drug if the disease gets worse, intolerable side effects occur, or
if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-study visit
and follow-up.
Early Withdrawal/End-of-Study Visit:
If you leave the study for any reason, the following tests will be performed.
- You will have a physical exam.
- Your performance status will be recorded.
- You will be asked about any drugs or treatments you may be receiving and any side
effects that you have had.
- Blood (about 3 teaspoons) will be drawn for routine tests.
- You will have CT scans and MRI scans to check the status of the disease.
- If the doctors thinks it is needed, you will have an eye exam.
Long-Term Follow-up:
After you are off-study, the study staff will collect information about how you are doing
either by checking your medical record or by calling you. If you are called, it will be
about 30 days after the last dose and then about every 3 months for up to 24 weeks. Each
call should only last about 5 minutes.
This is an investigational study. Pazopanib is FDA approved and commercially available for
kidney cancer. Its use to treat VHL is investigational.
Up to 40 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
RECIST Overall Response (OR) Rate = Number of Participants with Complete Response and Partial Response (CR+PR) at 24 weeks
Modified Response Evaluation Criteria in Solid Tumors (RECIST), evaluation of target lesions (organ-specific). Complete Response (CR): Disappearance all target lesions; Partial Response (PR): > 30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): > 20% increase in sum LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or > new lesions; Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD, reference smallest sum LD since treatment started.
24 weeks
No
Eric Jonasch, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2011-0465
NCT01436227
January 2012
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |