Imatinib Mesylate and Docetaxel in Non-Small Cell Lung Cancer (NSCLC)
The goal of this clinical research study is to learn how effective the combination of the drugs imatinib mesylate (Gleevec®) and docetaxel (Taxotere®) is in treating non-small cell lung cancer (NSCLC). The safety and tolerability of this drug combination will also be studied.
Non-small Cell Lung Cancer
Drug: Imatinib Mesylate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Imatinib Mesylate and Docetaxel in Pretreated Patients With Metastatic NSCLC|
- Patient Response Rate [ Time Frame: Baseline and with each 3 week cycle ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2005|
|Study Completion Date:||July 2011|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
Experimental: Imatinib Mesylate + Docetaxel
Imatinib Mesylate (Gleevec) Oral 400 mg daily + Docetaxel (Taxotere) 60 mg/m2 over 1 hour intravenous infusion repeated every 21 days.
Drug: Imatinib Mesylate
Oral 400 mg daily
Other Names:Drug: Docetaxel
60 mg/m2 over 1 hour intravenous infusion repeated every 21 days.
Other Name: Taxotere
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083589
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Anne S. Tsao, MD||UT MD Anderson Cancer Center|