Phase II Study of Imatinib Mesylate and Docetaxel in Pretreated Patients With Metastatic NSCLC
Imatinib mesylate is a medication that blocks certain proteins important in the development
of cancer. Docetaxel is a drug that is designed to target and destroy cancer cells.
If you are found to be eligible to take part in this study, you will take 4 imatinib
mesylate tablets by mouth once a day. Docetaxel will be given through a vein in your arm on
the first day of each treatment cycle for a total of 6 cycles. The infusion will take 1
hour. A treatment cycle on this study is 21 days.
You will need to take steroids (dexamethasone) before receiving docetaxel to try to prevent
fluid accumulation and hypersensitivity reactions. The dexamethasone will come in a pill
form to be taken every 12 hours for 3 days starting the day before chemotherapy. You will
also receive additional dexamethasone by vein before the docetaxel is given.
After you complete 6 treatment cycles, you will continue to take 4 imatinib mesylate tablets
each day until your cancer gets worse, or you experience unacceptable side effects, or you
withdraw from the study.
While on this study, you will have a physical exam every 3 weeks. During the first 5 weeks
of the study, you will have blood tests each week. About 3 teaspoons of blood will be drawn
each time. After the first 5 weeks, you will have blood tests (3 teaspoons each) at the
beginning of each treatment cycle. In addition, your tumor will be measured by a CT or MRI
scan every 6 weeks.
You must agree not to use herbal remedies or other over-the-counter therapies (e.g., shark
cartilage) during treatment.
If you develop any unacceptable symptoms or changes in your laboratory tests, your treatment
may be delayed and/or the dose decreased until the symptoms are gone. It may even be
necessary to stop your treatment. Your doctor will inform you of any changes in your dosing
schedule or in the doses of your medication after he/she evaluates you in the clinic.
After treatment ends, you will have a follow-up visit at the clinic. At this visit, you
will have a complete physical exam, including blood (about 3 teaspoons) and urine tests. You
will also have a CT scan to measure the size of the tumor in your body.
This is an investigational study. Imatinib mesylate is FDA approved for the treatment of
leukemia. Docetaxel is FDA approved for the treatment of breast, prostate, and NSCLC. Up to
50 patients will take part in this study. All will be enrolled at UTMDACC.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Patient Response Rate
Response rate to new regimen defined as the percentage of complete or partial response within the total number of patients treated. Treatment response assessed by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Baseline and with each 3 week cycle
Anne S. Tsao, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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