Imatinib Mesylate (Gleevec) and Docetaxel in Patients With Head and Neck Squamous Cell Cancer
- To determine the efficacy of the combination of imatinib mesylate and docetaxel in recurrent or metastatic head and neck squamous cell cancer by serial measurements of tumor response (extent, frequency, duration).
- To assess the safety and tolerability of imatinib mesylate and docetaxel in patients with recurrent or metastatic head and neck squamous cell cancer.
- To explore the biologic effects of imatinib mesylate and docetaxel on tumor tissue by immunohistochemical analysis of microvessel density and phosphorylation of Platelet-derived growth factor receptors (PDGF-R).
- To explore the effects of imatinib mesylate and docetaxel on surrogate markers in serum.
- To assess the rate of survival.
|Head and Neck Cancer Squamous Cell Cancer||Drug: Imatinib Mesylate Drug: Docetaxel||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of Imatinib Mesylate and Docetaxel in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Cancer|
- Participant Response Rate [ Time Frame: At 6 weeks reconfirmed 6 weeks later ]Response rate to regimen defined as the number of complete or partial response divided by the total number of participants treated. Tumor response defined by Response Evaluation Criteria In Solid Tumors (RECIST). All complete and partial responses confirmed by a second assessment six weeks later.
|Study Start Date:||January 2007|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Experimental: Imatinib Mesylate + Docetaxel
Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
Drug: Imatinib Mesylate
400 mg by mouth daily
Other Names:Drug: Docetaxel
60 mg/m^2 by vein (IV) over 1 hour every 3 weeks
Other Name: Taxotere
Imatinib mesylate is designed to block certain proteins important in the growth of cancer. Docetaxel 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 with a meal and a large glass of water (about 8-10 ounces.) A treatment cycle on this study is 21 days. You should keep normal eating habits, however a low-fat breakfast is recommended (for example, a light continental breakfast of toast and juice). Foods and drinks containing caffeine or grapefruit should be avoided. You should wait at least 1 hour after taking the last tablet before going to bed. If vomiting occurs, do not take any extra study medication.
You will be given a patient diary to record when you take your medication. You should bring the diary to each clinic visit, and the study nurse will review it each time.
Docetaxel will be given through a vein in your arm on the first day of each 21-day treatment cycle for a total of 6 cycles. The infusion will take 1 hour.
You will need to take steroids (dexamethasone) before receiving docetaxel to try to prevent fluid accumulation and allergic reactions. You will take dexamethasone by mouth twice a day on the day before the docetaxel infusion, the day of the infusion, and the day after infusion. You will receive an extra dose of dexamethasone (either through a needle in a vein or by mouth) on the day of infusion of the chemotherapy either through a needle in a vein or by mouth.
Every 3 weeks while on this study, you will have a physical exam, including measurement of your vital signs and weight, and a performance status evaluation. During the first 4 weeks, blood (about 3 teaspoons each time) will be drawn once a week for routine tests. After that, blood (about 3 teaspoons each time) will be drawn once at Week 5, once at Week 7, and then every 3 weeks after that. In addition, your tumor will be measured by a computed tomography (CT) or magnetic resonance imaging (MRI) scan every 6 weeks (at Weeks 7, 13, and 19).
If you develop any intolerable symptoms or certain changes in your blood tests, your treatment may be delayed and/or the dose may be decreased until the symptoms are gone. It may even be necessary to stop your treatment. You will be informed of any changes in your dosing schedule or in the doses of your medication after your doctor evaluates you in the clinic.
You may receive up to 6 cycles of the study treatment. Your continued participation in this study depends on how the cancer responds to the study drugs. Your doctor may decide to take you off this study if you experience intolerable side effects or the medical condition gets worse.
After you have completed all of your treatment, you will have an end-of-study visit. At this visit you will have a physical exam, including measurement of your vital signs and weight. You will have a performance status evaluation. You will have blood (about 3-4 teaspoons) drawn for routine tests. Your tumor will be measured by a CT or MRI scan.
This is an investigational study. Imatinib mesylate is FDA approved and docetaxel are FDA approved for other types of cancer however their use together in this study is investigational. Dexamethasone is required to be given with docetaxel. All three drugs are commercially available. Up to 58 patients will take part in this study. All will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485485
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Anne S. Tsao, MD||M.D. Anderson Cancer Center|