A Phase II Study of Dose-Dense Temozolomide and Lapatinib for Recurrent Low-Grade and Anaplastic Supratentorial, Infratentorial and Spinal Cord Ependymoma
The Study Drugs:
Temozolomide is designed to kill cancer cells by damaging DNA (the genetic material of
cells). This could cause the tumor cells to die.
Lapatinib is designed to prevent or slow down the growth of cancer cells by blocking
proteins inside the cancer cell, called the Her2/neu receptor and the epidermal growth
factor receptor (EGFR).
Study Drug Administration:
If you are found to be eligible to take part in this study, every day, you will take
lapatinib by mouth once a day in the morning. You should take lapatinib 1 hour before or 1
hour after eating, with at least 1 cup (about 8 oz.) of water.
On Days 1-7 and 15-21 of each cycle, you will take temozolomide by mouth 1 time each day.
You will start to take a lower dose of temozolomide for the first 2 cycles, then take a
higher dose for Cycles 3 and beyond if you tolerate the treatment. It should be taken at
least 2 hours before and 2 hours after eating with 1 cup (about 8 oz.) of water.
You should swallow temozolomide and/or lapatinib whole, one right after the other, without
chewing either of the study drugs. If you vomit while taking temozolomide and lapatinib, you
cannot take more capsules before the next scheduled dose. You should report any missed
pills or trouble you have with taking the pills to your study doctor. Your study doctor
will give you a form (patient diary) to fill out to keep track of your treatment. You will
be asked to return your completed diary and pill bottles at each visit with your doctor.
Each study "cycle" is 28 days.
Study Visits:
Every 2 weeks, blood (about 2-3 teaspoons) will be drawn for routine tests and to check your
blood's ability to clot.
Every 8 weeks, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs.
- You will have a neurological exam.
- Your performance status will be recorded.
- You will be asked about any drugs you may be taking and if you have experienced any
side effects.
- You will complete the quality of life questionnaire.
- You will have an MRI scan to check the status of the disease.
- You will have either a MUGA scan (if the doctor thinks it is needed) or an
echocardiogram.
Length of Study:
You will be on study treatment for up to 2 years. You will be taken off study treatment
early if the disease gets worse or you experience intolerable side effects.
After you are off study, you may be able to continue taking lapatinib for as long as the
doctor thinks it is in your best interest. Your doctor will discuss this with you.
End-of-Study Visit:
After you go off study treatment, 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.
- Your performance status will be recorded.
- You will be asked about any drugs you may be taking and if you have experienced any
side effects.
- You will have a neurological exam.
- Blood (about 3 teaspoons) will be drawn for routine tests and to check your blood's
ability to clot.
- You will complete the questionnaire.
- You will have an MRI scan to check the status of the disease.
- You will have either a MUGA scan (if the doctor thinks it is needed) or an
echocardiogram.
Long-Term Follow-up Visit:
If you go off treatment (having completed the maximum 24 months on study drug treatment) and
have stable disease or response, you will have an MRI scan to check the status of the
disease every 2 months for first year after you are off study, then every 3 months for the
second year, then every 4 months for the third year, and then every 6 months from then on.
If you continue taking lapatinib after you have completed up to 24 months on study
treatment, you will have a clinic visit and an MRI scan to check the status of the disease
every 2 months for as long as the doctor thinks it is needed. At the clinic visits, you
will be asked how you are doing.
If you went off study treatment because the disease got worse or you experienced intolerable
side effects, after the end-of-study visit, the study staff will call you every 3 months
from then on to check how you are doing. Each phone call will take about 5 minutes.
This is an investigational study. Temozolomide is FDA approved or commercially available
for the treatment of tumors of the nervous system. Lapatinib is FDA approved and
commercially available for the treatment of breast cancer. However, lapatinib is not FDA
approved for the treatment of brain tumors. The use of lapatinib with temozolomide in the
treatment of brain tumors and spinal tumors is investigational.
Up to 50 patients will take part in this multicenter study. Up to 30 will be enrolled at MD
Anderson.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Progression
Assessed every two months till disease progression
Yes
Mark R Gilbert, MD, BS
Principal Investigator
M.D. Anderson Cancer Center
United States: Institutional Review Board
CERN08-02
NCT00826241
January 2009
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
University of California, San Francisco | San Francisco, California 94143 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
UT MD Anderson Cancer Center | Houston, Texas 77030 |
University of Wisconsin School of Medicine and Public Health | Madison, Wisconsin 53792-5666 |
University of Pittsburgh Medical Center - Hillman Cancer Center | Pittsburgh, Pennsylvania 15232 |